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1. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: Results from the PRINTO/PRCSG registry

Author

Lovell, D, Tzaribachev, N, Henrickson, M, Simonini, G, Griffin, T, Alexeeva, E, Bohnsack, J, Zeft, A, Horneff, G, Vehe, R, Stanevica, V, Tarvin, S, Trachana, M, Del Rio, A, Huber, A, Kietz, D, Orban, I, Dare, J, Foeldvari, I, Quartier, P, Dominique, A, Simon, T, Martini, A, Brunner, H, Ruperto, N, Brunner, J, Fernandes, T, Appenzeller, S, Oliveira, S, Terreri, M, Minden, K, Hufnagel, M, Helling-Bakki, A, Herlin, T, Moreno, E, Anton, J, Del-Castillo, P, Udaondo, C, Penades, I, Brochard, K, Ramanan, A, Hashkes, P, Olivieri, A, Zulian, F, Montin, D, Peroni, D, Stanevicha, V, Cornejo, G, Wulffraat, N, Kamphuis, S, Gastanaga, M, Miraval, T, Oliveira-Ramos, F, Lazar, C, Nikishina, I, Sarychev, A, Chasnyk, V, Grebenkina, L, Suwairi, W, Koskova, E, Ally, M, Louw, I, Breedt, J, Ting, T, Taylor, J, Huggins, J, Dewitt, E, Grom, A, Schulert, G, Rodriguez-Smith, J, Morris, P, Sukumarain, S, Gitelman, M, Miller, M, Curran, M, Alperin, R, Ardalan, K, De Ranieri, D, Hiskey, M, Nolan, B, Chalom, B, Zelf, A, Spalding, S, Costanzo, D, Rennebohm, R, Waugaman, B, Brodus, E, Robinson, A, Panupattanapong, S, Rosenkranz, M, Cassidy, E, Torok, K, Kingsbury, D, Cartwright, V, Lasky, A, Brown, D, Reiff, A, Shaham, B, Marzan, K, Wagner-Weiner, L, Onel, K, Tesher, M, Edens, C, Moore, T, Syed, R, Pepmueller, P, Tuttle, P, Dalrymple, A, Barhula, S, Feller, L, Horwitz, M, Justice, M, Nocton, J, Olson, J, Williams, C, Versbsy, J, Co, D, Roth-Wojcicki, E, Correll, C, Binstadt, B, Hobday, P, Brueck, D, Gillispie-Taylor, M, Vora, S, O'Neil, K, Ballinger, S, Blakley, M, Klausmeier, T, Oliver, M, Stevens, B, Rodriguez, M, Go, E, Inman, C, Hersh, A, Stern, S, Woodward, A, Durkee, D, Boulva, S, James, K, Treemarcki, E, Goldsmith, D, Lvovich, S, Toib, D, Patel, J, Jerath, R, Sharma, N, Newhall, L, Carrasco, R, Moorthy, N, Boneparth, A, Quintero, A, Graham, T, Spence, S, Davis, A, Gotte, A, Mehta, J, Walters, H, Mian, Z, Parkinson, E, Hui-Yen, J, Steigerwald, K, Guzman, M, Gottlieb, B, Whitaker, C, Kelly, L, Succimarri, R, Hazel, E, Chedeville, G, Compillo, S, Leblance, C, Tucker, L, Cabral, D, Houghton, K, Guzman, J, Morishita, K, Stringer, E, Ramsey, S, Lang, B, Levy, D, Silverman, E, Schmeling, H, Johnson, N, Luca, N, Dhalla, M, Lovell D. J., Tzaribachev N., Henrickson M., Simonini G., Griffin T. A., Alexeeva E., Bohnsack J. F., Zeft A., Horneff G., Vehe R. K., Stanevica V., Tarvin S., Trachana M., Del Rio A. Q., Huber A. M., Kietz D., Orban I., Dare J., Foeldvari I., Quartier P., Dominique A., Simon T. A., Martini A., Brunner H. I., Ruperto N., Brunner J., Fernandes T., Appenzeller S., Oliveira S., Terreri M. T., Minden K., Hufnagel M., Helling-Bakki A., Herlin T., Moreno E., Anton J., Del-Castillo P. M. -., Udaondo C., Penades I. C., Brochard K., Ramanan A., Hashkes P. P., Olivieri A. N., Zulian F., Montin D., Peroni D., Stanevicha V., Cornejo G. V., Wulffraat N., Kamphuis S., Gastanaga M. E. P., Miraval T., Oliveira-Ramos F., Lazar C., Nikishina I., Sarychev A., Chasnyk V., Grebenkina L., Suwairi W. M. S., Koskova E., Ally M., Louw I., Breedt J., Brunner H., Ting T., Taylor J., Huggins J., Dewitt E. M., Grom A., Lovell D., Schulert G., Rodriguez-Smith J., Morris P., Sukumarain S., Gitelman M. K., Miller M., Curran M., Alperin R., Ardalan K., De Ranieri D., Hiskey M., Nolan B., Chalom B., Zelf A., Spalding S., Costanzo D., Rennebohm R., Waugaman B., Brodus E., Robinson A., Panupattanapong S., Rosenkranz M., Cassidy E., Torok K., Kingsbury D., Cartwright V., Lasky A., Brown D., Reiff A., Shaham B., Marzan K., Wagner-Weiner L., Onel K., Tesher M., Edens C., Moore T., Syed R., Pepmueller P., Tuttle P., Dalrymple A., Barhula S., Feller L., Horwitz M., Justice M., Nocton J., Olson J., Williams C., Versbsy J., Co D., Roth-Wojcicki E., Correll C., Vehe R., Binstadt B., Hobday P., Brueck D., Griffin T., Gillispie-Taylor M., Vora S., O'Neil K., Ballinger S., Blakley M., Klausmeier T., Oliver M., Stevens B., Rodriguez M., Go E., Bohnsack J., Inman C., Hersh A., Stern S., Woodward A., Durkee D., Boulva S. F., James K., Treemarcki E., Goldsmith D., Lvovich S., Toib D., Patel J., Jerath R., Sharma N., Newhall L., Carrasco R., Moorthy N., Boneparth A., Quintero A., Graham T., Spence S., Davis A., Gotte A., Mehta J., Walters H., Mian Z., Parkinson E., Hui-Yen J., Steigerwald K., Guzman M., Gottlieb B., Whitaker C., Kelly L., Succimarri R., Hazel E., Chedeville G., Compillo S., Leblance C., Tucker L., Cabral D., Houghton K., Guzman J., Morishita K., Huber A., Stringer E., Ramsey S., Lang B., Levy D., Silverman E., Schmeling H., Johnson N., Luca N., Dhalla M., Lovell, D, Tzaribachev, N, Henrickson, M, Simonini, G, Griffin, T, Alexeeva, E, Bohnsack, J, Zeft, A, Horneff, G, Vehe, R, Stanevica, V, Tarvin, S, Trachana, M, Del Rio, A, Huber, A, Kietz, D, Orban, I, Dare, J, Foeldvari, I, Quartier, P, Dominique, A, Simon, T, Martini, A, Brunner, H, Ruperto, N, Brunner, J, Fernandes, T, Appenzeller, S, Oliveira, S, Terreri, M, Minden, K, Hufnagel, M, Helling-Bakki, A, Herlin, T, Moreno, E, Anton, J, Del-Castillo, P, Udaondo, C, Penades, I, Brochard, K, Ramanan, A, Hashkes, P, Olivieri, A, Zulian, F, Montin, D, Peroni, D, Stanevicha, V, Cornejo, G, Wulffraat, N, Kamphuis, S, Gastanaga, M, Miraval, T, Oliveira-Ramos, F, Lazar, C, Nikishina, I, Sarychev, A, Chasnyk, V, Grebenkina, L, Suwairi, W, Koskova, E, Ally, M, Louw, I, Breedt, J, Ting, T, Taylor, J, Huggins, J, Dewitt, E, Grom, A, Schulert, G, Rodriguez-Smith, J, Morris, P, Sukumarain, S, Gitelman, M, Miller, M, Curran, M, Alperin, R, Ardalan, K, De Ranieri, D, Hiskey, M, Nolan, B, Chalom, B, Zelf, A, Spalding, S, Costanzo, D, Rennebohm, R, Waugaman, B, Brodus, E, Robinson, A, Panupattanapong, S, Rosenkranz, M, Cassidy, E, Torok, K, Kingsbury, D, Cartwright, V, Lasky, A, Brown, D, Reiff, A, Shaham, B, Marzan, K, Wagner-Weiner, L, Onel, K, Tesher, M, Edens, C, Moore, T, Syed, R, Pepmueller, P, Tuttle, P, Dalrymple, A, Barhula, S, Feller, L, Horwitz, M, Justice, M, Nocton, J, Olson, J, Williams, C, Versbsy, J, Co, D, Roth-Wojcicki, E, Correll, C, Binstadt, B, Hobday, P, Brueck, D, Gillispie-Taylor, M, Vora, S, O'Neil, K, Ballinger, S, Blakley, M, Klausmeier, T, Oliver, M, Stevens, B, Rodriguez, M, Go, E, Inman, C, Hersh, A, Stern, S, Woodward, A, Durkee, D, Boulva, S, James, K, Treemarcki, E, Goldsmith, D, Lvovich, S, Toib, D, Patel, J, Jerath, R, Sharma, N, Newhall, L, Carrasco, R, Moorthy, N, Boneparth, A, Quintero, A, Graham, T, Spence, S, Davis, A, Gotte, A, Mehta, J, Walters, H, Mian, Z, Parkinson, E, Hui-Yen, J, Steigerwald, K, Guzman, M, Gottlieb, B, Whitaker, C, Kelly, L, Succimarri, R, Hazel, E, Chedeville, G, Compillo, S, Leblance, C, Tucker, L, Cabral, D, Houghton, K, Guzman, J, Morishita, K, Stringer, E, Ramsey, S, Lang, B, Levy, D, Silverman, E, Schmeling, H, Johnson, N, Luca, N, Dhalla, M, Lovell D. J., Tzaribachev N., Henrickson M., Simonini G., Griffin T. A., Alexeeva E., Bohnsack J. F., Zeft A., Horneff G., Vehe R. K., Stanevica V., Tarvin S., Trachana M., Del Rio A. Q., Huber A. M., Kietz D., Orban I., Dare J., Foeldvari I., Quartier P., Dominique A., Simon T. A., Martini A., Brunner H. I., Ruperto N., Brunner J., Fernandes T., Appenzeller S., Oliveira S., Terreri M. T., Minden K., Hufnagel M., Helling-Bakki A., Herlin T., Moreno E., Anton J., Del-Castillo P. M. -., Udaondo C., Penades I. C., Brochard K., Ramanan A., Hashkes P. P., Olivieri A. N., Zulian F., Montin D., Peroni D., Stanevicha V., Cornejo G. V., Wulffraat N., Kamphuis S., Gastanaga M. E. P., Miraval T., Oliveira-Ramos F., Lazar C., Nikishina I., Sarychev A., Chasnyk V., Grebenkina L., Suwairi W. M. S., Koskova E., Ally M., Louw I., Breedt J., Brunner H., Ting T., Taylor J., Huggins J., Dewitt E. M., Grom A., Lovell D., Schulert G., Rodriguez-Smith J., Morris P., Sukumarain S., Gitelman M. K., Miller M., Curran M., Alperin R., Ardalan K., De Ranieri D., Hiskey M., Nolan B., Chalom B., Zelf A., Spalding S., Costanzo D., Rennebohm R., Waugaman B., Brodus E., Robinson A., Panupattanapong S., Rosenkranz M., Cassidy E., Torok K., Kingsbury D., Cartwright V., Lasky A., Brown D., Reiff A., Shaham B., Marzan K., Wagner-Weiner L., Onel K., Tesher M., Edens C., Moore T., Syed R., Pepmueller P., Tuttle P., Dalrymple A., Barhula S., Feller L., Horwitz M., Justice M., Nocton J., Olson J., Williams C., Versbsy J., Co D., Roth-Wojcicki E., Correll C., Vehe R., Binstadt B., Hobday P., Brueck D., Griffin T., Gillispie-Taylor M., Vora S., O'Neil K., Ballinger S., Blakley M., Klausmeier T., Oliver M., Stevens B., Rodriguez M., Go E., Bohnsack J., Inman C., Hersh A., Stern S., Woodward A., Durkee D., Boulva S. F., James K., Treemarcki E., Goldsmith D., Lvovich S., Toib D., Patel J., Jerath R., Sharma N., Newhall L., Carrasco R., Moorthy N., Boneparth A., Quintero A., Graham T., Spence S., Davis A., Gotte A., Mehta J., Walters H., Mian Z., Parkinson E., Hui-Yen J., Steigerwald K., Guzman M., Gottlieb B., Whitaker C., Kelly L., Succimarri R., Hazel E., Chedeville G., Compillo S., Leblance C., Tucker L., Cabral D., Houghton K., Guzman J., Morishita K., Huber A., Stringer E., Ramsey S., Lang B., Levy D., Silverman E., Schmeling H., Johnson N., Luca N., and Dhalla M.

Abstract

Objective: The aim of this study was to report the interim 5-year safety and effectiveness of abatacept in patients with JIA in the PRINTO/PRCSG registry. Methods: The Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Results: As of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% CI: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections [IR 1.48 (95% CI: 0.88, 2.34)]. As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improvement over 5 years across JIA categories. Conclusion: Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission.

Published
2024

2. Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study

Author

Brunner, H, Pacheco-Tena, C, Louw, I, Vega-Cornejo, G, Alexeeva, E, Appenzeller, S, Chasnyk, V, Griffin, T, Suarez, C, Knupp-Oliveira, S, Zeft, A, Aviel, Y, De Ranieri, D, Gottlieb, B, Levy, D, Rabinovich, C, Silva, C, Spivakovsky, Y, Uziel, Y, Ringold, S, Xu, X, Leu, J, Lam, E, Wang, Y, Lovell, D, Martini, A, Ruperto, N, Brunner H. I., Pacheco-Tena C., Louw I., Vega-Cornejo G., Alexeeva E., Appenzeller S., Chasnyk V., Griffin T., Suarez C. N., Knupp-Oliveira S., Zeft A., Aviel Y. B., De Ranieri D., Gottlieb B. S., Levy D. M., Rabinovich C. E., Silva C. A., Spivakovsky Y., Uziel Y., Ringold S., Xu X. L., Leu J. H., Lam E., Wang Y., Lovell D. J., Martini A., Ruperto N., Brunner, H, Pacheco-Tena, C, Louw, I, Vega-Cornejo, G, Alexeeva, E, Appenzeller, S, Chasnyk, V, Griffin, T, Suarez, C, Knupp-Oliveira, S, Zeft, A, Aviel, Y, De Ranieri, D, Gottlieb, B, Levy, D, Rabinovich, C, Silva, C, Spivakovsky, Y, Uziel, Y, Ringold, S, Xu, X, Leu, J, Lam, E, Wang, Y, Lovell, D, Martini, A, Ruperto, N, Brunner H. I., Pacheco-Tena C., Louw I., Vega-Cornejo G., Alexeeva E., Appenzeller S., Chasnyk V., Griffin T., Suarez C. N., Knupp-Oliveira S., Zeft A., Aviel Y. B., De Ranieri D., Gottlieb B. S., Levy D. M., Rabinovich C. E., Silva C. A., Spivakovsky Y., Uziel Y., Ringold S., Xu X. L., Leu J. H., Lam E., Wang Y., Lovell D. J., Martini A., and Ruperto N.

Published
2024

4. OP0036 EFFICACY, SAFETY, AND PHARMACOKINETICS OF ANTI-CD40 ANTIBODY ABIPRUBART (KPL-404) IN PATIENTS WITH RHEUMATOID ARTHRITIS: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED 12-WEEK-TREATMENT PROOF-OF-CONCEPT STUDY

Author

Jenkins, E., primary, Louw, I., additional, Balog, A., additional, Van Duuren, E., additional, Horowitz, D. L., additional, Jaworski, J., additional, Kivitz, A., additional, Ujfalussy, I., additional, Pirello, J., additional, Tessari, E., additional, Wang, S., additional, and Paolini, J. F., additional

Published
2024
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5. Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept

Author

Brunner, H, Tzaribachev, N, Louw, I, Calvo Penades, I, Avila-Zapata, F, Horneff, G, Foeldvari, I, Kingsbury, D, Paz Gastanaga, M, Wouters, C, Breedt, J, Wong, R, Askelson, M, Zhuo, J, Martini, A, Lovell, D, Ruperto, N, Brunner H. I., Tzaribachev N., Louw I., Calvo Penades I., Avila-Zapata F., Horneff G., Foeldvari I., Kingsbury D. J., Paz Gastanaga M. E., Wouters C., Breedt J., Wong R., Askelson M., Zhuo J., Martini A., Lovell D. J., Ruperto N., Brunner, H, Tzaribachev, N, Louw, I, Calvo Penades, I, Avila-Zapata, F, Horneff, G, Foeldvari, I, Kingsbury, D, Paz Gastanaga, M, Wouters, C, Breedt, J, Wong, R, Askelson, M, Zhuo, J, Martini, A, Lovell, D, Ruperto, N, Brunner H. I., Tzaribachev N., Louw I., Calvo Penades I., Avila-Zapata F., Horneff G., Foeldvari I., Kingsbury D. J., Paz Gastanaga M. E., Wouters C., Breedt J., Wong R., Askelson M., Zhuo J., Martini A., Lovell D. J., and Ruperto N.

Abstract

Objective: To investigate the frequency and trajectories of individual patients with polyarticular-course juvenile idiopathic arthritis (JIA) achieving novel composite end points on abatacept. Methods: Data from a clinical trial of subcutaneous abatacept (NCT01844518) and a post hoc analysis of intravenous abatacept (NCT00095173) in patients with polyarticular-course JIA were included. Three end points were defined and evaluated: combined occurrence of low disease activity (LDA) measured by the Juvenile Arthritis Disease Activity Score; 50% improvement in American College of Rheumatology criteria for JIA (ACR50); and patient-reported outcomes. Patient-reported outcomes included visual analog scale score of minimal pain (pain-min) and Childhood Health Assessment Questionnaire disability index score of 0 (C-HAQ DI0). In this post hoc analysis, maintenance of month 13 and 21 end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) in those who achieved them at month 4 was determined. Results: Composite end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) were achieved at month 4 (44.7%, 19.6%, and 58.9% of the 219 patients treated with subcutaneous abatacept, respectively). Of those who achieved LDA+pain-min at month 4, 84.7% (83 of 98) and 65.3% (64 of 98) maintained LDA+pain-min at months 13 and 21, respectively. The proportions of patients meeting LDA+pain-min outcomes increased from 44.7% (98 of 219) at month 4 to 54.8% (120 of 219) at month 21. The frequency of patients who met an LDA+C-HAQ DI score of 0 increased from 19.6% (43 of 219) at month 4 to 28.8% (63 of 219) at month 21. Conclusion: Among individual patients with polyarticular-course JIA treated with abatacept who achieved 1 of the combined clinical and patient-reported outcomes composite end points, many maintained them over 21 months of abatacept treatment.

Published
2023

6. Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis

Author

Ruperto, N, Brunner, H, Pacheco-Tena, C, Louw, I, Vega-Cornejo, G, Spindler, A, Kingsbury, D, Schmeling, H, Borzutzky, A, Cuttica, R, Inman, C, Malievskiy, V, Scott, C, Keltsev, V, Terreri, M, Viola, D, Xavier, R, Fernandes, T, Velázquez, M, Henrickson, M, Clark, M, Bensley, K, Li, X, Lo, K, Leu, J, Hsu, C, Hsia, E, Xu, Z, Martini, A, Lovell, D, Ruperto N, Brunner HI, Pacheco-Tena C, Louw I, Vega-Cornejo G, Spindler AJ, Kingsbury DJ, Schmeling H, Borzutzky A, Cuttica R, Inman CJ, Malievskiy V, Scott C, Keltsev V, Terreri MT, Viola DO, Xavier RM, Fernandes TAP, Velázquez MDRM, Henrickson M, Clark MB, Bensley KA, Li X, Lo KH, Leu JH, Hsu CH, Hsia EC, Xu Z, Martini A, Lovell DJ, Ruperto, N, Brunner, H, Pacheco-Tena, C, Louw, I, Vega-Cornejo, G, Spindler, A, Kingsbury, D, Schmeling, H, Borzutzky, A, Cuttica, R, Inman, C, Malievskiy, V, Scott, C, Keltsev, V, Terreri, M, Viola, D, Xavier, R, Fernandes, T, Velázquez, M, Henrickson, M, Clark, M, Bensley, K, Li, X, Lo, K, Leu, J, Hsu, C, Hsia, E, Xu, Z, Martini, A, Lovell, D, Ruperto N, Brunner HI, Pacheco-Tena C, Louw I, Vega-Cornejo G, Spindler AJ, Kingsbury DJ, Schmeling H, Borzutzky A, Cuttica R, Inman CJ, Malievskiy V, Scott C, Keltsev V, Terreri MT, Viola DO, Xavier RM, Fernandes TAP, Velázquez MDRM, Henrickson M, Clark MB, Bensley KA, Li X, Lo KH, Leu JH, Hsu CH, Hsia EC, Xu Z, Martini A, and Lovell DJ

Published
2021

7. Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis

Author

Ruperto, N, Brunner, H, Tzaribachev, N, Vega-Cornejo, G, Louw, I, Cimaz, R, Dare, J, Espada, G, Faugier, E, Ferrandiz, M, Gerloni, V, Quartier, P, Silva, C, Wagner-Weiner, L, Gandhi, Y, Passarell, J, Nys, M, Wong, R, Martini, A, Lovell, D, Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ, Ruperto, N, Brunner, H, Tzaribachev, N, Vega-Cornejo, G, Louw, I, Cimaz, R, Dare, J, Espada, G, Faugier, E, Ferrandiz, M, Gerloni, V, Quartier, P, Silva, C, Wagner-Weiner, L, Gandhi, Y, Passarell, J, Nys, M, Wong, R, Martini, A, Lovell, D, Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, and Lovell DJ

Abstract

Objective. To assess the relationship between infection risk and abatacept (ABA) exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous (SC) and intravenous (IV) ABA. Methods. Data from 2 published studies (ClinicalTrials.gov: NCT01844518, NCT00095173) of ABA treatment in pediatric patients were analyzed. One study treated patients aged 2.17 years with SC ABA and the other treated patients aged 6.17 years with IV ABA. Association between serum ABA exposure measures and infection was evaluated using Kaplan-Meier plots of probability of first infection vs time on treatment by ABA exposure quartiles and log-rank tests. Number of infections by ABA exposure quartiles was investigated. Results. Overall, 343 patients were included in this analysis: 219 patients received SC ABA and 124 patients received IV ABA. Overall, 237/343 (69.1%) patients had ≥ 1 infection over 24 months. No significant difference in time to first infection across 4 quartiles of ABA exposure levels was observed in the pooled (P = 0.45), SC (2.5 yrs: P = 0.93; 6.17 yrs: P = 0.48), or IV (P = 0.50) analyses. Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) with ABA did not increase infection risk across the ABA exposure quartiles. There was no evidence of association between number of infections and ABA exposure quartiles. No opportunistic infections related to ABA were reported. Conclusion. In patients aged 2.17 years with pJIA, no evidence of association between higher levels of exposure to IV ABA or SC ABA and incidence of infection was observed.

Published
2021

8. OP0221 EFFICACY OF SECUKINUMAB IN ENTHESITIS-RELATED ARTHRITIS: RESULTS FROM A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT WITHDRAWAL, PHASE 3 STUDY (JUNIPERA)

Author

Ruperto, N., primary, Chertok, E., additional, Dehoorne, J., additional, Horneff, G., additional, Kallinich, T., additional, Louw, I., additional, Compeyrot-Lacassagne, S., additional, Lauwerys, B., additional, Martin, N., additional, Marzan, K., additional, Knibbe, W., additional, Martin, R., additional, Zhu, X., additional, Whelan, S., additional, Pricop, L., additional, Martini, A., additional, Lovell, D. J., additional, and Brunner, H., additional

Published
2022
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9. Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Author

Brunner H. I., Tzaribachev N., Vega-Cornejo G., Louw I., Berman A., Calvo Penades I., Anton J., Avila-Zapata F., Cuttica R., Horneff G., Foeldvari I., Keltsev V., Kingsbury D. J., Viola D. O., Joos R., Lauwerys B., Paz Gastanaga M. E., Rama M. E., Wouters C., Bohnsack J., Breedt J., Fischbach M., Lutz T., Minden K., Miraval T., Ally M. M. T. M., Rubio-Perez N., Solau Gervais E., van Zyl R., Li X., Nys M., Wong R., Banerjee S., Lovell D. J., Martini A., Ruperto N., Becker M. L., Ilowite N. T., Dare J. A., Morris P. K., Beukelman T. G., Wagner-Weiner L., Zemel L., Quartier P., Kone-Paut I., Belot A., Gerloni V., Ferrandiz M., Van Rensburg D. J., Scheibel I. M., Goldstein-Schainberg C., Silva C., Terreri M. T. S. E. L. A., Gamir M., Burgos Vargas R., Faugier Fuentes E., Cimaz R., Alessio M., Espada G., Brunner, H. I., Tzaribachev, N., Vega-Cornejo, G., Louw, I., Berman, A., Calvo Penades, I., Anton, J., Avila-Zapata, F., Cuttica, R., Horneff, G., Foeldvari, I., Keltsev, V., Kingsbury, D. J., Viola, D. O., Joos, R., Lauwerys, B., Paz Gastanaga, M. E., Rama, M. E., Wouters, C., Bohnsack, J., Breedt, J., Fischbach, M., Lutz, T., Minden, K., Miraval, T., Ally, M. M. T. M., Rubio-Perez, N., Solau Gervais, E., van Zyl, R., Li, X., Nys, M., Wong, R., Banerjee, S., Lovell, D. J., Martini, A., Ruperto, N., Becker, M. L., Ilowite, N. T., Dare, J. A., Morris, P. K., Beukelman, T. G., Wagner-Weiner, L., Zemel, L., Quartier, P., Kone-Paut, I., Belot, A., Gerloni, V., Ferrandiz, M., Van Rensburg, D. J., Scheibel, I. M., Goldstein-Schainberg, C., Silva, C., Terreri, M. T. S. E. L. A., Gamir, M., Burgos Vargas, R., Faugier Fuentes, E., Cimaz, R., Alessio, M., and Espada, G.

Subjects
Male, musculoskeletal diseases, 0301 basic medicine, medicine.medical_specialty, Adolescent, genetic structures, Immunology, Juvenile, Arthritis, Injections, Subcutaneou, Abatacept, Arthritis, Juvenile, Child, Child, Preschool, Cohort Studies, Female, Humans, Immunosuppressive Agents, Injections, Subcutaneous, Treatment Outcome, Injections, Immunosuppressive Agent, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Pharmacokinetics, Open label study, medicine, Immunology and Allergy, In patient, Preschool, skin and connective tissue diseases, 030203 arthritis & rheumatology, business.industry, Subcutaneous, medicine.disease, Dermatology, Clinical trial, 030104 developmental biology, Methotrexate, Cohort Studie, business, Human, medicine.drug
Abstract

Objective: To investigate the pharmacokinetics, effectiveness, and safety of subcutaneous (SC) abatacept treatment over 24 months in patients with polyarticular-course juvenile idiopathic arthritis (JIA). Methods: In this phase III, open-label, international, multicenter, single-arm study, patients with polyarticular JIA (cohort 1, ages 6–17 years and cohort 2, ages 2–5 years) in whom treatment with ≥1 disease-modifying antirheumatic drug was unsuccessful received weight-tiered SC abatacept weekly: 10 to

Published
2018
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10. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial)

Author

Isenberg, David, Gordon, Caroline, Licu, Daiana, Copt, Samuel, Rossi, Claudia Pena, Wofsy, David, Babini, A, Lazaro, M, Lucero, E, Merono, C, Rillo, O, Spindler, A, Tate, G, Velasco Zamora, B, Bossingham, D, Littlejohn, G, Nicholls, D, Reeves, G, Rischmueller, M, Zamani, O, Sato, E, Scheinberg, M, Zerbini, C, Rashkov, R, Glasnovic, M, Martinovic-Kaliterna, D, Morovic-Vergles, J, Novak, S, Tegzova, D, Vavrincova, P, Amoura, Z, Carle, P, Hachulla, E, Jorgensen, C, Sibilia, J, Viallard, J, Braun, J, Hiepe, F, Kuhn, A, Lorenz, H, Schmidt, R, Schulze-Koops, H, Wacker, J, Settas, L, Mouli Veeravalli, S, Balbir-Gurman, A, Langevitz, P, Mevorach, D, Molad, Y, Bae, S, Cho, CS, Kim, HY, Suh, C, Andersone, D, Ziade, N, Baranauskaite, A, Stropuviene, S, Gun, S, Kong, N, Sulaiman, W, Ramos Remus, C, Saldate Alonso, C, Huizinga, T, Tak, P, van Paassen, P, Arroyo, C, Gomez, H, Perez, E, Ramiterre, E, Salido, E, Brzosko, M, Chudzik, D, Dyczek, A, Jeka, S, Sierakowski, S, Zdrojewski, Z, Barbarash, O, Ershova, O, Gordienko, A, Lomareva, N, Shvarts, Y, Sorotskaya, V, Vezikova, N, Yakushin, S, Bogic, M, Dimic, A, Damjanov, N, Petrovic, R, Stojanovic, L, Kalla, A, Louw, I, Nayiager, S, Reuter, H, Spargo, C, Whitelaw, D, Carbonell Abello, J, Fernandez Nebro, A, Gomez Reino, J, Lopez Longo, F, von Kempis, J, Huang, CM, Lan, JL, Lin, HY, Liou, LB, Bruce, I, Tahir, H, Abrahamovych, O, Dyadyk, O, Nikirenkov, Y, Rudyk, Y, Smiyan, S, Stanislavchuk, M, Ter-Vartanyan, S, Aranow, C, Askanase, A, Chakravarty, E, Chatham, W, Clark, M, Dhar, P, Dikranian, A, Fiechtner, J, Ginzler, E, Harmon, C, Knibbe, W, Lee, E, Lockshin, M, Luggen, M, Massarotti, E, Mitri, G, Peng, S, and Singer, N

Published
2015
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11. O.51 - Abatacept sous-cutané chez des patients présentant une arthrite juvénile idiopathique polyarticulaire et une réponse inadéquate aux DMARDs conventionnels ou biologiques : pharmacocinétique, efficacité et sécurité

Author

Solau-Gervais, E., Lovell, D., Ruperto, N., Tzaribachev, N., Vega-Cornejo, G., Louw, I., Berman, A., Calvo, I., Cuttica, R., Horneff, G., Avila-Zapata, F., Anton, J., Cimaz, R., Joos, R., Espada, G., Li, X., Nys, M., Wong, R., Banerjee, S., Brunner, H., and Martini, A.

Published
2016
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12. Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Author

Giancane G1, Swart JF2, Castagnola E3, Groll AH4, Horneff G5, 6, Huppertz HI7, Lovell DJ8, Wolfs T2, Herlin T9, Dolezalova P10, Sanner H11, Susic G13, Sztajnbok F14, Maritsi D15, Constantin T16, Vargova V17, Sawhney S18, Rygg M19, K Oliveira S21, Cattalini M22, Bovis F1, Bagnasco F1, Pistorio A23, Martini A24, Wulffraat N2, Ruperto N25, Paediatric Rheumatology International Trials Organisation (PRINTO). Cuttica R, Garay SM, Brunner J, Emminger W, Appenzeller S, Len C, Saad Magalhaes C, Telcharova-Mihaylovska A, Harjacek M, Jelusic M, Estmann A, Nielsen S, Herrera Mora C, Gervais E, Koné-Paut I, Quartier P, Foeldvari I, Horneff G, Lutz T, Minden K, Tzaribachev N, Trachana M, Tsitsami E, Vougiouka O, Orban I, Harel L, Hashkes P, Uziel Y, Cimaz R, Civino A, Consolini R, D'Angelo G, De Benedetti F, Filocamo G, Fueri E, Gallizzi R, Maggio MC, Magnolia MG, Miniaci A, Montin D, Olivieri A. N., Pastore S, Rigante D, Zulian F, Rumba-Rozenfelde I, Stanevicha V, Panaviene V, Rodriguez Lozano AL, Rubio-Perez N, Vega Cornejo G, Hoppenreijs E, Kamphuis S, Flato B, Nordal EB, Abdwani R, Miraval T, Paz Gastanaga ME, Smolewska E, Ailioaie C, Cochino AV, Laday M, Lazar C, Alexeeva E, Chasnyk V, Keltsev V, Suwairi WMS, Vijatov-Djuric G, Vojinovic J, Arkachaisri T, Koskova E, Avcin T, Ally M, Van Rensburg CJ, Louw I, Lopez JA, Boteanu AL, Calvo Penades I, De Inocencio J, Mesa-Del-Castillo P, Moreno E, Remesal A, Hofer M, Gok F, Ozen S, Ramanan A, Pallotti C, Villa L., Giancane, G1, Swart, Jf2, Castagnola, E3, Groll, Ah4, Horneff, G5, Huppertz, Hi7, Lovell, Dj8, Wolfs, T2, Herlin, T9, Dolezalova, P10, Sanner, H11, Susic, G13, Sztajnbok, F14, Maritsi, D15, Constantin, T16, Vargova, V17, Sawhney, S18, Rygg, M19, K Oliveira, S21, Cattalini, M22, Bovis, F1, Bagnasco, F1, Pistorio, A23, Martini, A24, Wulffraat, N2, Ruperto, N25, Paediatric Rheumatology International Trials Organisation (PRINTO)., Cuttica R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Horneff, G, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, A. N., Pastore, S, Rigante, D, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L., Giancane, Gabriella, Swart, Joost F, Castagnola, Elio, Groll, Andreas H, Horneff, Gerd, Huppertz, Hans-Iko, Lovell, Daniel J, Wolfs, Tom, Herlin, Troel, Dolezalova, Pavla, Sanner, Helga, Susic, Gordana, Sztajnbok, Flavio, Maritsi, Despoina, Constantin, Tama, Vargova, Veronika, Sawhney, Sujata, Rygg, Marite, K Oliveira, Sheila, Cattalini, Marco, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, Ruperto, Nicolino, Cuttica, Ruben, Garay, Stella Mari, Brunner, Jurgen, Emminger, Wolfgang, Appenzeller, Simone, Len, Claudio, Saad Magalhaes, Claudia, Telcharova-Mihaylovska, Albena, Harjacek, Miroslav, Jelusic, Marija, Estmann, Anne, Nielsen, Susan, Herrera Mora, Cristina, Gervais, Elisabeth, Koné-Paut, Isabelle, Quartier, Pierre, Foeldvari, Ivan, Lutz, Thoma, Minden, Kirsten, Tzaribachev, Nikolay, Trachana, Maria, Tsitsami, Elena, Vougiouka, Olga, Orban, Ilonka, Harel, Liora, Hashkes, Philip, Uziel, Yosef, Cimaz, Rolando, Civino, Adele, Consolini, Rita, D'Angelo, Gianfranco, De Benedetti, Fabrizio, Filocamo, Giovanni, Fueri, Elena, Gallizzi, Romina, Maggio, Maria Cristina, Magnolia, Maria Greca, Miniaci, Angela, Montin, Davide, Olivieri, Alma Nunzia, Pastore, Serena, Rigante, Donato, Zulian, Francesco, Rumba-Rozenfelde, Ingrida, Stanevicha, Valda, Panaviene, Violeta, Rodriguez Lozano, Ana Luisa, Rubio-Perez, Nadina, Vega Cornejo, Gabriel, Hoppenreijs, Esther, Kamphuis, Sylvia, Flato, Berit, Nordal, Ellen Berit, Abdwani, Reem, Miraval, Tatiana, Paz Gastanaga, Maria Eliana, Smolewska, Elzbieta, Ailioaie, Constantin, Cochino, Alexis-Virgil, Laday, Matilda, Lazar, Calin, Alexeeva, Ekaterina, Chasnyk, Vyacheslav, Keltsev, Vladimir, Suwairi, Wafaa Mohammed Saad, Vijatov-Djuric, Gordana, Vojinovic, Jelena, Arkachaisri, Thaschawee, Koskova, Elena, Avcin, Tadej, Ally, Mahmood, Van Rensburg, Christa Janse, Louw, Ingrid, Lopez, Jordi Anton, Boteanu, Alina Lucica, Calvo Penades, Inmaculada, De Inocencio, Jaime, Mesa-Del-Castillo, Pablo, Moreno, Estefania, Remesal, Agustin, Hofer, Michael, Gok, Faysal, Ozen, Seza, Ramanan, Athimalaipet, Pallotti, Chiara, Villa, Luca, and Pediatrics

Subjects
Male, lcsh:Diseases of the musculoskeletal system, Biologic, Paediatrics: 760 [VDP], Artritis infecciosa, MedDRA, Infants malalts, Arthritis, Severity of Illness Index, Hospital patients, Cohort Studies, Pharmacovigilance, 0302 clinical medicine, 030212 general & internal medicine, Registries, Child, Biologics, Immunosuppressive therapy, Infections, Juvenile idiopathic arthritis, Opportunistic, biologics, immunosuppressive therapy, infections, juvenile idiopathic arthritis, opportunistic, Barneleddgikt, 3. Good health, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Antirheumatic Agents, Child, Preschool, Cohort, Pediatric Infectious Disease, Female, Infection, Research Article, medicine.medical_specialty, Tuberculosis, juvenil idiopathic arthritis, Opportunistic Infections, Herpes Zoster, 03 medical and health sciences, Immunocompromised Host, Juvenile idiopathic arthriti, Internal medicine, medicine, Humans, book, 030203 arthritis & rheumatology, Malalts hospitalitzats, Immunosupressió, business.industry, Sick children, medicine.disease, Rheumatology, Arthritis, Juvenile, Infectious arthritis, Pediatri: 760 [VDP], Orthopedic surgery, Opportunistiske infeksjoner, book.journal, lcsh:RC925-935, business, Infeccions oportunistes, Immunosuppression
Abstract

Background: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results: A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions: We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies. © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Published
2020
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17. Maintien d’une maladie inactive ou avec une activité minimale et des réponses PROs chez des patients pédiatriques atteints d’arthrite juvénile idiopathique et traités par abatacept par voie sous-cutanée

Author

Brunner, H., primary, Tzaribachev, N., additional, Louw, I., additional, Calvo, I., additional, Avila-Zapata, F., additional, Horneff, G., additional, Foeldvari, I., additional, Kingsbury, D., additional, Gastanaga, M., additional, Wouters, C., additional, Breedt, J., additional, Wong, R., additional, Nys, M., additional, Askelson, M., additional, Zhuo, J., additional, Martini, A., additional, Lovell, D., additional, Quartier, P., additional, and Ruperto, N., additional

Published
2020
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18. THU0497 MAINTENANCE OF MINIMAL DISEASE ACTIVITY OR INACTIVE DISEASE STATUS AND PATIENT-REPORTED OUTCOMES IN INDIVIDUAL PAEDIATRIC PATIENTS WITH JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH SUBCUTANEOUS ABATACEPT

Author

Brunner, H., primary, Tzaribachev, N., additional, Louw, I., additional, Calvo, I., additional, Zapata, F., additional, Horneff, G., additional, Foeldvari, I., additional, Kingsbury, D., additional, Gastanaga, M., additional, Wouters, C., additional, Breedt, J., additional, Wong, R., additional, Nys, M., additional, Askelson, M., additional, Zhuo, J., additional, Martini, A., additional, Lovell, D. J., additional, and Ruperto, N., additional

Published
2020
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20. Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: Analysis by the Pharmachild Safety Adjudication Committee

Author

Giancane, G. Swart, J.F. Castagnola, E. Groll, A.H. Horneff, G. Huppertz, H.-I. Lovell, D.J. Wolfs, T. Herlin, T. Dolezalova, P. Sanner, H. Susic, G. Sztajnbok, F. Maritsi, D. Constantin, T. Vargova, V. Sawhney, S. Rygg, M. Oliveira, S.K. Cattalini, M. Bovis, F. Bagnasco, F. Pistorio, A. Martini, A. Wulffraat, N. Ruperto, N. Cuttica, R. Garay, S.M. Brunner, J. Emminger, W. Appenzeller, S. Len, C. Saad Magalhaes, C. Telcharova-Mihaylovska, A. Harjacek, M. Jelusic, M. Estmann, A. Nielsen, S. Herrera Mora, C. Gervais, E. Koné-Paut, I. Quartier, P. Foeldvari, I. Horneff, G. Lutz, T. Minden, K. Tzaribachev, N. Trachana, M. Tsitsami, E. Vougiouka, O. Orban, I. Harel, L. Hashkes, P. Uziel, Y. Cimaz, R. Civino, A. Consolini, R. D'Angelo, G. De Benedetti, F. Filocamo, G. Fueri, E. Gallizzi, R. Maggio, M.C. Magnolia, M.G. Miniaci, A. Montin, D. Olivieri, A.N. Pastore, S. Rigante, D. Zulian, F. Rumba-Rozenfelde, I. Stanevicha, V. Panaviene, V. Rodriguez Lozano, A.L. Rubio-Perez, N. Vega Cornejo, G. Hoppenreijs, E. Kamphuis, S. Flato, B. Nordal, E.B. Abdwani, R. Miraval, T. Paz Gastanaga, M.E. Smolewska, E. Ailioaie, C. Cochino, A.-V. Laday, M. Lazar, C. Alexeeva, E. Chasnyk, V. Keltsev, V. Suwairi, W.M.S. Vijatov-Djuric, G. Vojinovic, J. Arkachaisri, T. Koskova, E. Avcin, T. Ally, M. Van Rensburg, C.J. Louw, I. Lopez, J.A. Boteanu, A.L. Calvo Penades, I. De Inocencio, J. Mesa-Del-Castillo, P. Moreno, E. Remesal, A. Hofer, M. Gok, F. Ozen, S. Ramanan, A. Pallotti, C. Villa, L. and Giancane, G. Swart, J.F. Castagnola, E. Groll, A.H. Horneff, G. Huppertz, H.-I. Lovell, D.J. Wolfs, T. Herlin, T. Dolezalova, P. Sanner, H. Susic, G. Sztajnbok, F. Maritsi, D. Constantin, T. Vargova, V. Sawhney, S. Rygg, M. Oliveira, S.K. Cattalini, M. Bovis, F. Bagnasco, F. Pistorio, A. Martini, A. Wulffraat, N. Ruperto, N. Cuttica, R. Garay, S.M. Brunner, J. Emminger, W. Appenzeller, S. Len, C. Saad Magalhaes, C. Telcharova-Mihaylovska, A. Harjacek, M. Jelusic, M. Estmann, A. Nielsen, S. Herrera Mora, C. Gervais, E. Koné-Paut, I. Quartier, P. Foeldvari, I. Horneff, G. Lutz, T. Minden, K. Tzaribachev, N. Trachana, M. Tsitsami, E. Vougiouka, O. Orban, I. Harel, L. Hashkes, P. Uziel, Y. Cimaz, R. Civino, A. Consolini, R. D'Angelo, G. De Benedetti, F. Filocamo, G. Fueri, E. Gallizzi, R. Maggio, M.C. Magnolia, M.G. Miniaci, A. Montin, D. Olivieri, A.N. Pastore, S. Rigante, D. Zulian, F. Rumba-Rozenfelde, I. Stanevicha, V. Panaviene, V. Rodriguez Lozano, A.L. Rubio-Perez, N. Vega Cornejo, G. Hoppenreijs, E. Kamphuis, S. Flato, B. Nordal, E.B. Abdwani, R. Miraval, T. Paz Gastanaga, M.E. Smolewska, E. Ailioaie, C. Cochino, A.-V. Laday, M. Lazar, C. Alexeeva, E. Chasnyk, V. Keltsev, V. Suwairi, W.M.S. Vijatov-Djuric, G. Vojinovic, J. Arkachaisri, T. Koskova, E. Avcin, T. Ally, M. Van Rensburg, C.J. Louw, I. Lopez, J.A. Boteanu, A.L. Calvo Penades, I. De Inocencio, J. Mesa-Del-Castillo, P. Moreno, E. Remesal, A. Hofer, M. Gok, F. Ozen, S. Ramanan, A. Pallotti, C. Villa, L.

Abstract

Background: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results: A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions: We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies. Trial registration: Clinicaltrials.gov NCT 01399281; ENCePP seal: awarded on 25 November 2011. © 2020 The Author(s).

Published
2020

21. COPD: Should Diagnosis Match Physiology?

Author

Studnicka, M, Horner, A, Sator, L, Buist, AS, Lamprecht, B, Zhong, NS, Liu, S, Lu, J, Ran, P, Wang, D, Zheng, J, Zhou, Y, Kocabaş, A, Hancioglu, A, Hanta, I, Kuleci, S, Turkyilmaz, AS, Umut, S, Unalan, T, Dawes, T, Bateman, E, Jithoo, A, Adams, D, Barnes, E, Freeman, J, Hayes, A, Hlengwa, S, Johannisen, C, Koopman, M, Louw, I, Ludick, I, Olckers, A, Ryck, J, Storbeck, J, Gislason, T, Benedikdtsdottir, B, Jörundsdottir, K, Gudmundsdottir, L, Gudmundsdottir, S, Gundmundsson, G, Nizankowska-Mogilnicka, E, Frey, J, Harat, R, Mejza, F, Nastalek, P, Pajak, A, Skucha, W, Szczeklik, A, Twardowska, M, Welte, T, Bodemann, I, Geldmacher, H, Schweda-Linow, A, Gulsvik, A, Endresen, T, Svendsen, L, Tan, WC, Wang, W, Mannino, DM, Cain, J, Copeland, R, Hazen, D, Methvin, J, Dantes, RB, Amarillo, L, Berratio, LU, Fernandez, LC, Francisco, NA, Garcia, GS, de Guia, TS, Idolor, LF, Naval, SS, Reyes, T, Roa, CC, Sanchez, MF, Simpao, LP, Jenkins, C ; https://orcid.org/0000-0003-2717-5647, Marks, G ; https://orcid.org/0000-0002-8976-8053, Bird, T, Espinel, P, Hardaker, K, Toelle, B ; https://orcid.org/0000-0002-7375-0019, Burney, PGJ, Amor, C, Potts, J, Tumilty, M, McLean, F, Wouters, EFM, Wesseling, GJ, Bárbara, C, Rodrigues, F, Dias, H, Cardoso, J, Almeida, J, Matos, MJ, Simão, P, Santos, M, Ferreira, R, Janson, C, Olafsdottir, IS, Studnicka, M, Horner, A, Sator, L, Buist, AS, Lamprecht, B, Zhong, NS, Liu, S, Lu, J, Ran, P, Wang, D, Zheng, J, Zhou, Y, Kocabaş, A, Hancioglu, A, Hanta, I, Kuleci, S, Turkyilmaz, AS, Umut, S, Unalan, T, Dawes, T, Bateman, E, Jithoo, A, Adams, D, Barnes, E, Freeman, J, Hayes, A, Hlengwa, S, Johannisen, C, Koopman, M, Louw, I, Ludick, I, Olckers, A, Ryck, J, Storbeck, J, Gislason, T, Benedikdtsdottir, B, Jörundsdottir, K, Gudmundsdottir, L, Gudmundsdottir, S, Gundmundsson, G, Nizankowska-Mogilnicka, E, Frey, J, Harat, R, Mejza, F, Nastalek, P, Pajak, A, Skucha, W, Szczeklik, A, Twardowska, M, Welte, T, Bodemann, I, Geldmacher, H, Schweda-Linow, A, Gulsvik, A, Endresen, T, Svendsen, L, Tan, WC, Wang, W, Mannino, DM, Cain, J, Copeland, R, Hazen, D, Methvin, J, Dantes, RB, Amarillo, L, Berratio, LU, Fernandez, LC, Francisco, NA, Garcia, GS, de Guia, TS, Idolor, LF, Naval, SS, Reyes, T, Roa, CC, Sanchez, MF, Simpao, LP, Jenkins, C ; https://orcid.org/0000-0003-2717-5647, Marks, G ; https://orcid.org/0000-0002-8976-8053, Bird, T, Espinel, P, Hardaker, K, Toelle, B ; https://orcid.org/0000-0002-7375-0019, Burney, PGJ, Amor, C, Potts, J, Tumilty, M, McLean, F, Wouters, EFM, Wesseling, GJ, Bárbara, C, Rodrigues, F, Dias, H, Cardoso, J, Almeida, J, Matos, MJ, Simão, P, Santos, M, Ferreira, R, Janson, C, and Olafsdottir, IS

Published
2020

22. Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Author

Giancane, G, Swart, Jf, Castagnola, E, Groll, Ah, Horneff, G, Huppertz, Hi, Lovell, Dj, Wolfs, T, Herlin, T, Dolezalova, P, Sanner, H, Susic, G, Sztajnbok, F, Maritsi, D, Constantin, T, Vargova, V, Sawhney, S, Rygg, M, K Oliveira, S, Cattalini, M, Bovis, F, Bagnasco, F, Pistorio, A, Martini, A, Wulffraat, N, Ruperto, N, Cuttica, R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, An, Pastore, S, Rigante, Donato, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L &amp, Paediatric Rheumatology International Trials Organisation, (PRINTO), Rigante D (ORCID:0000-0001-7032-7779), Giancane, G, Swart, Jf, Castagnola, E, Groll, Ah, Horneff, G, Huppertz, Hi, Lovell, Dj, Wolfs, T, Herlin, T, Dolezalova, P, Sanner, H, Susic, G, Sztajnbok, F, Maritsi, D, Constantin, T, Vargova, V, Sawhney, S, Rygg, M, K Oliveira, S, Cattalini, M, Bovis, F, Bagnasco, F, Pistorio, A, Martini, A, Wulffraat, N, Ruperto, N, Cuttica, R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, An, Pastore, S, Rigante, Donato, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L &amp, Paediatric Rheumatology International Trials Organisation, (PRINTO), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

BACKGROUND: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). METHODS: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. RESULTS: A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. CONCLUSIONS: We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies.

Published
2020

24. Overdiagnosis of COPD in Subjects With Unobstructed Spirometry: A BOLD Analysis

Author

Sator, L, Horner, A, Studnicka, M, Lamprecht, B, Kaiser, B, McBurnie, M, Buist, A, Gnatiuc, L, Mannino, D, Janson, C, Bateman, E, Burney, P, Zhong, N, Liu, S, Lu, J, Ran, P, Wang, D, Zheng, J, Zhou, Y, Kocabaş, A, Hancioglu, A, Hanta, I, Kuleci, S, Turkyilmaz, A, Umut, S, Unalan, T, Dawes, T, Jithoo, A, Adams, D, Barnes, E, Freeman, J, Hayes, A, Hlengwa, S, Johannisen, C, Koopman, M, Louw, I, Ludick, I, Olckers, A, Ryck, J, Storbeck, J, Gislason, T, Benedikdtsdottir, B, Jörundsdottir, K, Gudmundsdottir, L, Gudmundsdottir, S, Gundmundsson, G, Nizankowska-Mogilnicka, E, Frey, J, Harat, R, Mejza, F, Nastalek, P, Pajak, A, Skucha, W, Szczeklik, A, Twardowska, M, Welte, T, Bodemann, I, Geldmacher, H, Schweda-Linow, A, Gulsvik, A, Endresen, T, Svendsen, L, Tan, W, Wang, W, Cain, J, Copeland, R, Hazen, D, Methvin, J, Dantes, R, Amarillo, L, Berratio, L, Fernandez, L, Francisco, N, Garcia, G, De Guia, T, Idolor, L, Naval, S, Reyes, T, Roa, C, Sanchez, M, Simpao, L, Jenkins, C, Marks, G, Bird, T, Espinel, P, Hardaker, K, Toelle, B, Amor, C, Potts, J, Tumilty, M, McLean, F, Wouters, E, Wesseling, G, Bárbara, C, Rodrigues, F, Dias, H, Cardoso, J, Almeida, J, Matos, M, Simão, P, Santos, M, Ferreira, R, Olafsdottir, I, Nisser, K, Spetz-Nyström, U, Hägg, G, Lund, G, Jõgi, R, Laja, H, Ulst, K, Zobel, V, Lill, T, Koul, P, Malik, S, Hakim, N, Khan, U, Chowgule, R, Shetye, V, Raphael, J, Almeda, R, Tawde, M, Tadvi, R, Katkar, S, Kadam, M, Dhanawade, R, Ghurup, U, Harrabi, I, Denguezli, M, Tabka, Z, Daldoul, H, Boukheroufa, Z, Chouikha, F, Khalifa, W, Ayuyao, F, Tady, C, Tan, D, Banal-Yang, S, Balanag, V, Reyes, M, Juvekar, S, Hirve, S, Sambhudas, S, Chaidhary, B, Tambe, M, Pingale, S, Umap, A, Shelar, N, Devchakke, S, Chaudhary, S, Bondre, S, Walke, S, Gawhane, A, Sapkal, A, Argade, R, Gaikwad, V, Salvi, S, Brashier, B, Londhe, J, Madas, S, Obaseki, D, Erhabor, G, Awopeju, O, and Adewole, O

Subjects
respiratory tract diseases
Abstract

Background There are several reports on underdiagnosis of COPD, while little is known about COPD overdiagnosis and overtreatment. We describe the overdiagnosis and the prevalence of spirometrically defined false positive COPD, as well as their relationship with overtreatment across 23 population samples in 20 countries participating in the BOLD Study between 2003 and 2012. Methods A false positive diagnosis of COPD was considered when participants reported a doctor’s diagnosis of COPD, but postbronchodilator spirometry was unobstructed (FEV1/FVC > LLN). Additional analyses were performed using the fixed ratio criterion (FEV1/FVC < 0.7). Results Among 16,177 participants, 919 (5.7%) reported a previous medical diagnosis of COPD. Postbronchodilator spirometry was unobstructed in 569 subjects (61.9%): false positive COPD. A similar rate of overdiagnosis was seen when using the fixed ratio criterion (55.3%). In a subgroup analysis excluding participants who reported a diagnosis of “chronic bronchitis” or “emphysema” (n = 220), 37.7% had no airflow limitation. The site-specific prevalence of false positive COPD varied greatly, from 1.9% in low- to middle-income countries to 4.9% in high-income countries. In multivariate analysis, overdiagnosis was more common among women, and was associated with higher education; former and current smoking; the presence of wheeze, cough, and phlegm; and concomitant medical diagnosis of asthma or heart disease. Among the subjects with false positive COPD, 45.7% reported current use of respiratory medication. Excluding patients with reported asthma, 34.4% of those with normal spirometry still used a respiratory medication. Conclusions False positive COPD is frequent. This might expose nonobstructed subjects to possible adverse effects of respiratory medication.

Published
2019

25. Gaps in using bronchodilators, inhaled corticosteroids and influenza vaccine among 23 high- and low-income sites

Author

Gnatiuc, L, Buist, AS, Kato, BS, Janson, C, Aït-Khaled, N, Nielsen, R, Koul, PA, Nizankowska-Mogilnicka, E, Obaseki, D, Idolor, LF, Harrabi, I, Burney, PGJ, Vollmer, W, Gillespie, S, McBurnie, M, Jithoo, A, Coton, S, Azhar, H, Zhong, NS, Liu, SM, Lu, JC, Ran, PX, Wang, DL, Zheng, JP, Zhou, YM, Kocabas, A, Hancioglu, A, Hanta, I, Kuleci, S, Turkyilmaz, AS, Umut, S, Unalan, T, Studnicka, M, Dawes, T, Lamprecht, B, Schirhofer, L, Bateman, E, Adams, D, Barnes, E, Freeman, J, Hayes, A, Hlengwa, S, Johannisen, C, Koopman, M, Louw, I, Ludick, I, Olckers, A, Ryck, J, Storbeck, J, Gislason, T, Benedikdtsdottir, B, Jorundsdottir, K, Gudmundsdottir, L, Gudmundsdottir, S, Gundmundsson, G, Frey, J, Harat, R, Mejza, F, Nastalek, P, Pajak, A, Skucha, W, Szczeklik, A, Twardowska, M, Welte, T, Bodemann, I, Geldmacher, H, Schweda-Linow, A, Gulsvik, A, Endresen, T, Svendsen, L, Tan, WC, Wang, W, Mannino, DM, Cain, J, Copeland, R, Hazen, D, Methvin, J, Dantes, RB, Amarillo, L, Berratio, LU, Fernandez, LC, Francisco, NA, Garcia, GS, De Guia, TS, Naval, SS, BOLD Collaboration, and Çukurova Üniversitesi

Subjects
Pulmonary and Respiratory Medicine, Low income, Influenza vaccine, business.industry, Cross-sectional study, Determinants for use, Inhaled corticosteroids, medicine.disease, Prevention of exacerbations, Vaccination, Copd and asthma treatments, Infectious Diseases, Multicenter study, Low and middle income countries, Environmental health, Immunology, medicine, business, Essential respiratory medications, Asthma
Abstract

Background Increasing access to essential respiratory medicines and influenza vaccination has been a priority for over three decades. Their use remains low in low- and middle-income countries (LMICs), where little is known about factors influencing use, or about the use of influenza vaccination for preventing respiratory exacerbations. Methods We estimated rates of regular use of bronchodilators, inhaled corticosteroids and influenza vaccine, and predictors for use among 19 000 adults in 23 high-income countries (HICs) and LMIC sites. Results Bronchodilators, inhaled corticosteroids and influenza vaccine were used significantly more in HICs than in LMICs, after adjusting for similar clinical needs. Although they are used more commonly by people with symptomatic or severe respiratory disease, the gap between HICs and LMICs is not explained by the prevalence of chronic obstructive pulmonary disease or doctor-diagnosed asthma. Site-specific factors are likely to influence use differently. The gross national income per capita for the country is a strong predictor for use of these treatments, suggesting that economics influence under-treatment. Conclusion We still need a better understanding of determinants for the low use of essential respiratory medicines and influenza vaccine in low-income settings. Identifying and addressing these more systematically could improve the access and use of effective treatments.

Published
2015
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27. OP0058 Improvement in patient-reported outcomes in patients with polyarticular-course juvenile idiopathic arthritis and inadequate response to biologic or non-biologic disease-modifying antirheumatic drugs treated with sc abatacept

Author

Ruperto, N, primary, Brunner, H, additional, Tzaribachev, N, additional, Vega-Cornejo, G, additional, Louw, I, additional, Anton, J, additional, Viola, D, additional, Foeldvari, I, additional, Keltsev, V, additional, Kingsbury, D, additional, Wouters, C, additional, Lauwerys, B, additional, Alemao, E, additional, Wong, R, additional, Nys, M, additional, Banerjee, S, additional, Martini, A, additional, and Lovell, D, additional

Published
2017
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28. Impact of Mathematics and Physics on the Success of South African Engineering Technology Students

Author

Ben van Wyk, Wiecher H.A. Hofman, Louw, I., and Teaching and Teacher Education

Subjects
MATHEMATICS, Engineering, education, dropout
Abstract

The general conclusion arrived at in the literature is that the South African National Senior Certificate (NSC) is not a reliable predictor of academic success at traditional universities. By sharing research undertaken at a South African University of Technology (UoT) on the impact of individual cognitive factors and NSC results on study success, this paper shows that this conclusion is not necessarily true for South African UoT Engineering students. To assess this impact and determine the readiness of students for UoT Engineering curricula, the relationship between pre-university academic factors and the success of engineering students was investigated. An ex post facto study was carried out on a sample of 416 students drawn from first-time-entering National Diploma engineering student cohorts of 2009 and 2010 to determine a possible correlation between their NSC results, additional pre-admission test results and the number of subjects passed after one year and four years of study, respectively. The findings indicated that NSC Mathematics and Physical Science are statistically the most significant predictors of success in the first year. Despite the pre-admission tests used in this study not revealing significantly more about a student’s potential than only the final NSC results, the conclusion reached by the researchers was that such tests might be useful when student application data is unreliable, i.e. when students apply with Grade 11 or interim Grade 12 results.

Published
2015

29. Abatacept sous-cutané chez des patients présentant une arthrite juvénile idiopathique polyarticulaire et une réponse inadéquate aux DMARDs conventionnels ou biologiques: pharmacocinétique, efficacité et sécurité

Author

Solau-Gervais, E., primary, Lovell, D., additional, Ruperto, N., additional, Tzaribachev, N., additional, Vega-Cornejo, G., additional, Louw, I., additional, Berman, A., additional, Calvo, I., additional, Cuttica, R., additional, Horneff, G., additional, Avila-Zapata, F., additional, Anton, J., additional, Cimaz, R., additional, Joos, R., additional, Espada, G., additional, Li, X., additional, Nys, M., additional, Wong, R., additional, Banerjee, S., additional, Brunner, H., additional, and Martini, A., additional

Published
2016
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30. OP0215 Subcutaneous Abatacept in Patients with Polyarticular Juvenile Idiopathic Arthritis and Inadequate Response To Biologic or Non-Biologic Disease-Modifying Antirheumatic Drugs: Pharmacokinetics, Efficacy and Safety

Author

Ruperto, N., primary, Lovell, D.J., additional, Tzaribachev, N., additional, Vega-Cornejo, G., additional, Louw, I., additional, Berman, A., additional, Calvo, I., additional, Cuttica, R., additional, Horneff, G., additional, Avila-Zapata, F., additional, Anton, J., additional, Viola, D., additional, Foeldvari, I., additional, Keltsev, V., additional, Kingsbury, D., additional, Li, X., additional, Nys, M., additional, Wong, R., additional, Banerjee, S., additional, Martini, A., additional, and Brunner, H.I., additional

Published
2016
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31. Infliximab Plus Methotrexate Is Superior To Methotrexate Alone In The Treatment Of Psoriatic Arthritis In Methotrexate-Naive Patients: The Respond Study

Author

Baranauskaite A., Raffayová H., Kungurov N.V., Kubanova A., Venalis A., Helmle L., Srinivasan S., Nasonov E., Vastesaeger N., Nasyrova R., Parsik E., Otsa K., Butrimiene I., Pileckyte M., Tlustochowicz W., Kucharz E., Szekanecz Z., Poor G., Koo E., Hodinka L., Macejova Z., Direskeneli H., Akkoc N., Kabasakal Y., Ertenli I., Khatib F., Van Duuren E.M., Spargo C., Louw I., Codreanu C., Ionescu R., Chireac R.M., Rednic S., Hammoudeh M., Szechinski J., Rell-Bakalarska M., Avraham D., Andersone D., Keszthelyi P., Suranyi P., İç Hastalıkları, and Ege Üniversitesi

Subjects
musculoskeletal diseases, Adult, Male, medicine.medical_specialty, Immunology, Pharmacology, Severity of Illness Index, General Biochemistry, Genetics and Molecular Biology, Dactylitis, Psoriatic arthritis, Rheumatology, Psoriasis Area and Severity Index, Internal medicine, Severity of illness, medicine, Immunology and Allergy, Humans, skin and connective tissue diseases, business.industry, Arthritis, Psoriatic, Enthesitis, Antibodies, Monoclonal, Middle Aged, Clinical and Epidemiological Research, medicine.disease, Infliximab, Methotrexate, Treatment Outcome, Antirheumatic Agents, Drug Therapy, Combination, Female, medicine.symptom, business, Immunosuppressive Agents, medicine.drug
Abstract

Objective: To compare the efficacy and safety of treatment with infliximab plus methotrexate with methotrexate alone in methotrexate-naive patients with active psoriatic arthritis (PsA). Methods: In this open-label study, patients 18 years and older with active PsA who were naive to methotrexate and not receiving disease-modifying therapy (N=115) were randomly assigned (1:1) to receive either infliximab (5 mg/kg) at weeks 0, 2, 6 and 14 plus methotrexate (15 mg/week); or methotrexate (15 mg/week) alone. The primary assessment was American College of Rheumatology (ACR) 20 response at week 16. Secondary outcome measures included psoriasis area and severity index (PASI), disease activity score in 28 joints (DAS28) and dactylitis and enthesitis assessments. Results: At week 16, 86.3% of patients receiving infliximab plus methotrexate and 66.7% of those receiving methotrexate alone achieved an ACR20 response (p

Published
2012

32. Prediction of Remission and Low Disease Activity in DMARD-Refractory Patients with RA Treated with Golimumab

Author

Vastesaeger, N, Durez, P, Dasgupta, B, Combe, B, Schulze-Koops, H, Louw, I, Wollenhaupt, J, Zerbini, C, Beaulieu, A, Pavelka, K, Lazaro, M, Garcia Kutzbach, A, Moots, RJ, Amital, H, Huyck, S, Fu, B, Govoni, M, Vastesaeger, N, Durez, P, Dasgupta, B, Combe, B, Schulze-Koops, H, Louw, I, Wollenhaupt, J, Zerbini, C, Beaulieu, A, Pavelka, K, Lazaro, M, Garcia Kutzbach, A, Moots, RJ, Amital, H, Huyck, S, Fu, B, and Govoni, M

Published
2015

33. SAT0160 Prediction of Remission and Low Disease Activity in Dmard-Refractory Patients with RA Treated with Golimumab

Author

Vastesaeger, N., primary, Durez, P., additional, Dasgupta, B., additional, Combe, B., additional, Schulze-Koops, H., additional, Louw, I., additional, Wollenhaupt, J., additional, Zerbini, C.A.F., additional, Beaulieu, A., additional, Pavelka, K., additional, Lazaro, M., additional, Garcia Kutzbach, A., additional, Moots, R.J., additional, Amital, H., additional, Huyck, S., additional, Fu, B., additional, and Govoni, M., additional

Published
2015
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34. THU0155 Predictors of Low Disease Activity and Remission after One Dose of Golimumab in Patients with Rheumatoid Arthritis

Author

Dasgupta, B., primary, Combe, B., additional, Durez, P., additional, Schulze-Koops, H., additional, Louw, I., additional, Wollenhaupt, J., additional, Zerbini, C., additional, Beaulieu, A., additional, Yao, R., additional, Huyck, S., additional, Govoni, M., additional, Weng, H.H., additional, and Vastesaeger, N., additional

Published
2014
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37. Impact of Mathematics and Physical Science on the Success of South African Engineering Technology Students.

Author

VAN WYK, B. J., HOFMAN, WAH, and LOUW, I.

Subjects
ENGINEERING education, MATHEMATICS education, PHYSICS education, ENGINEERING students, ENGINEERING teachers, UNIVERSITIES & colleges
Abstract

The general conclusion arrived at in the literature is that the South African National Senior Certificate (NSC) is not a reliable predictor of academic success at traditional universities. By sharing research undertaken at a South African University of Technology (UoT) on the impact of individual cognitive factors and NSC results on study success, this paper shows that this conclusion is not necessarily true for South African UoT Engineering students. To assess this impact and determine the readiness of students for UoT Engineering curricula, the relationship between pre-university academic factors and the success of engineering students was investigated. An ex post facto study was carried out on a sample of 416 students drawn from first-time-entering National Diploma engineering student cohorts of 2009 and 2010 to determine a possible correlation between their NSC results, additional pre-admission test results and the number of subjects passed after one year and four years of study, respectively. The findings indicated that NSC Mathematics and Physical Science are statistically the most significant predictors of success in the first year. Despite the pre-admission tests used in this study not revealing significantly more about a student's potential than only the final NSC results, the conclusion reached by the researchers was that such tests might be useful when student application data is unreliable, i.e. when students apply with Grade 11 or interim Grade 12 results. [ABSTRACT FROM AUTHOR]

Published
2015

38. Impact of mathematics and physical science on the success of South African engineering technology students

Author

Wyk, B. J., Wiecher H.A. Hofman, Louw, I., and Teaching and Teacher Education

Subjects
Admission testing, Student dropout, National Senior Certificate, First-year success, Cognitive factors, Engineering curricula
Abstract

The general conclusion arrived at in the literature is that the South African National Senior Certificate (NSC) is not a reliable predictor of academic success at traditional universities. By sharing research undertaken at a South African University of Technology (UoT) on the impact of individual cognitive factors and NSCresults on study success, this paper shows that this conclusion is not necessarily true for South African UoT Engineering students. To assess this impact and determine the readiness of students for UoT Engineering curricula, the relationship between pre-university academic factors and the success of engineering students was investigated. An ex post facto study was carried out on a sample of 416 students drawn from first-time-entering National Diploma engineering student cohorts of 2009 and 2010 to determine a possible correlation between their NSC results, additional pre-admission test results and the number of subjects passed after one year and four years of study, respectively. The findings indicated thatNSC Mathematics and Physical Science are statistically the most significant predictors of success in the first year. Despite the pre-admission tests used in this study not revealing significantly more about a student's potential than only the final NSC results, the conclusion reached by the researchers was that such tests might be useful when student application data is unreliable, i.e. when students apply with Grade 11 or interim Grade 12 results.

39. Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study.

Author

Brunner HI, Pacheco-Tena C, Louw I, Vega-Cornejo G, Alexeeva E, Appenzeller S, Chasnyk V, Griffin T, Suarez CN, Knupp-Oliveira S, Zeft A, Aviel YB, De Ranieri D, Gottlieb BS, Levy DM, Rabinovich CE, Silva CA, Spivakovsky Y, Uziel Y, Ringold S, Xu XL, Leu JH, Lam E, Wang Y, Lovell DJ, Martini A, and Ruperto N

Subjects
Humans, Female, Male, Child, Treatment Outcome, Adolescent, Administration, Intravenous, Methotrexate therapeutic use, Methotrexate administration & dosage, Child, Preschool, Severity of Illness Index, Arthritis, Juvenile drug therapy, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal adverse effects, Antirheumatic Agents administration & dosage, Antirheumatic Agents therapeutic use
Abstract

Objective: To report pharmacokinetics (PK), immunogenicity, clinical effect, and safety of intravenous (IV) golimumab in children with active polyarticular-course juvenile idiopathic arthritis (pcJIA) who participated in A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (GO-VIVA)'s open-label, long-term extension (LTE) through week 252., Methods: GO-VIVA participants who continued IV golimumab (80 mg/m 2 every 8 weeks) after week 52 were included. PK and safety were assessed through week 244 (last dose) and week 252, respectively, and clinical response through week 116. Clinical outcomes included JIA-American College of Rheumatology (ACR) responses and clinical Juvenile Arthritis Disease Activity Score in 10 joints (cJADAS10). Binary outcomes used nonresponder imputation, and other descriptive analyses used observed data., Results: Of 112/127 (88.2%) participants entering the LTE, 69 completed the week 252 visit. Median steady-state trough golimumab concentrations were generally maintained from week 52 through week 244 (range 0.3-0.6 μg/mL). Antigolimumab antibody rates were consistent through week 52 (39.2% [49/125]) and week 244 (44.8% [56/125]). Week 52 JIA-ACR 30/50/70/90 response rates (75.6% [96/127], 74% [94/127], 65.4% [83/127], and 48.8% [62/127], respectively) were generally maintained through week 116 (72.4% [92/127], 71.7% [91/127], 63.8% [81/127], and 50.4% [64/127], respectively), when the median cJADAS10 was 1.6 and 56.7% (72/127) of participants achieved cJADAS10 ≤ 5 (minimal disease activity). Rates (per 100 patient-years) of serious adverse events and serious infections through week 252 were 7.7 and 3.9, respectively., Conclusion: GO-VIVA LTE participants experienced adequate PK exposure and stable safety and immunogenicity. The majority of participants experienced no more than minimal residual disease activity. Data suggest IV golimumab treatment provided durable clinical response through week 116, with an acceptable risk-benefit profile., (Copyright © 2024 by the Journal of Rheumatology.)

Published
2024
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40. Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept.

Author

Brunner HI, Tzaribachev N, Louw I, Calvo Penades I, Avila-Zapata F, Horneff G, Foeldvari I, Kingsbury DJ, Paz Gastanaga ME, Wouters C, Breedt J, Wong R, Askelson M, Zhuo J, Martini A, Lovell DJ, and Ruperto N

Subjects
Humans, Child, Abatacept adverse effects, Treatment Outcome, Pain, Arthritis, Juvenile diagnosis, Arthritis, Juvenile drug therapy, Antirheumatic Agents adverse effects
Abstract

Objective: To investigate the frequency and trajectories of individual patients with polyarticular-course juvenile idiopathic arthritis (JIA) achieving novel composite end points on abatacept., Methods: Data from a clinical trial of subcutaneous abatacept (NCT01844518) and a post hoc analysis of intravenous abatacept (NCT00095173) in patients with polyarticular-course JIA were included. Three end points were defined and evaluated: combined occurrence of low disease activity (LDA) measured by the Juvenile Arthritis Disease Activity Score; 50% improvement in American College of Rheumatology criteria for JIA (ACR50); and patient-reported outcomes. Patient-reported outcomes included visual analog scale score of minimal pain (pain-min) and Childhood Health Assessment Questionnaire disability index score of 0 (C-HAQ DI0). In this post hoc analysis, maintenance of month 13 and 21 end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) in those who achieved them at month 4 was determined., Results: Composite end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) were achieved at month 4 (44.7%, 19.6%, and 58.9% of the 219 patients treated with subcutaneous abatacept, respectively). Of those who achieved LDA+pain-min at month 4, 84.7% (83 of 98) and 65.3% (64 of 98) maintained LDA+pain-min at months 13 and 21, respectively. The proportions of patients meeting LDA+pain-min outcomes increased from 44.7% (98 of 219) at month 4 to 54.8% (120 of 219) at month 21. The frequency of patients who met an LDA+C-HAQ DI score of 0 increased from 19.6% (43 of 219) at month 4 to 28.8% (63 of 219) at month 21., Conclusion: Among individual patients with polyarticular-course JIA treated with abatacept who achieved 1 of the combined clinical and patient-reported outcomes composite end points, many maintained them over 21 months of abatacept treatment., (© 2023 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Published
2023
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41. Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis.

Author

Ruperto N, Brunner HI, Pacheco-Tena C, Louw I, Vega-Cornejo G, Spindler AJ, Kingsbury DJ, Schmeling H, Borzutzky A, Cuttica R, Inman CJ, Malievskiy V, Scott C, Keltsev V, Terreri MT, Viola DO, Xavier RM, Fernandes TAP, Velázquez MDRM, Henrickson M, Clark MB, Bensley KA, Li X, Lo KH, Leu JH, Hsu CH, Hsia EC, Xu Z, Martini A, and Lovell DJ

Subjects
Administration, Intravenous, Adolescent, Child, Child, Preschool, Female, Humans, Male, Treatment Outcome, Antibodies, Monoclonal administration & dosage, Antirheumatic Agents administration & dosage, Arthritis drug therapy, Arthritis, Juvenile drug therapy
Abstract

Objectives: To assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA)., Methods: Children aged 2 to <18 years with active pc-JIA despite MTX therapy for ≥2 months received 80 mg/m2 golimumab at weeks 0, 4, then every 8 weeks through week 52 plus MTX weekly through week 28. The primary and major secondary endpoints were PK exposure and model-predicted steady-state area under the curve (AUCss) over an 8-week dosing interval at weeks 28 and 52, respectively. JIA ACR response and safety were also assessed., Results: In total, 127 children were treated with i.v. golimumab. JIA ACR 30, 50, 70, and 90 response rates were 84%, 80%, 70% and 47%, respectively, at week 28 and were maintained through week 52. Golimumab serum concentrations and AUCss were 0.40 µg/ml and 399 µg ⋅ day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUCss were consistent across age categories and comparable to i.v. golimumab dosed 2 mg/kg in adults with rheumatoid arthritis. Golimumab antibodies and neutralizing antibodies were detected via a highly sensitive drug-tolerant assay in 31% (39/125) and 19% (24/125) of patients, respectively. Median trough golimumab concentration was lower in antibody-positive vs antibody-negative patients. Serious infections were reported in 6% of patients, including one death due to septic shock., Conclusion: Body surface area-based dosing of i.v. golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA.ClinicalTrials.gov number NCT02277444., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Published
2021
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42. Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis.

Author

Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, and Lovell DJ

Subjects
Child, Humans, Methotrexate adverse effects, Treatment Outcome, Abatacept adverse effects, Antirheumatic Agents adverse effects, Arthritis, Juvenile drug therapy, Infections epidemiology
Abstract

Objective: To assess the relationship between infection risk and abatacept (ABA) exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous (SC) and intravenous (IV) ABA., Methods: Data from 2 published studies (ClinicalTrials.gov: NCT01844518, NCT00095173) of ABA treatment in pediatric patients were analyzed. One study treated patients aged 2-17 years with SC ABA and the other treated patients aged 6-17 years with IV ABA. Association between serum ABA exposure measures and infection was evaluated using Kaplan-Meier plots of probability of first infection vs time on treatment by ABA exposure quartiles and log-rank tests. Number of infections by ABA exposure quartiles was investigated., Results: Overall, 343 patients were included in this analysis: 219 patients received SC ABA and 124 patients received IV ABA. Overall, 237/343 (69.1%) patients had ≥ 1 infection over 24 months. No significant difference in time to first infection across 4 quartiles of ABA exposure levels was observed in the pooled ( P = 0.45), SC (2-5 yrs: P = 0.93; 6-17 yrs: P = 0.48), or IV ( P = 0.50) analyses. Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) with ABA did not increase infection risk across the ABA exposure quartiles. There was no evidence of association between number of infections and ABA exposure quartiles. No opportunistic infections related to ABA were reported., Conclusion: In patients aged 2-17 years with pJIA, no evidence of association between higher levels of exposure to IV ABA or SC ABA and incidence of infection was observed., (Copyright © 2021 by the Journal of Rheumatology.)

Published
2021
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43. Nurse-led care for the management of rheumatoid arthritis: a review of the global literature and proposed strategies for implementation in Africa and the Middle East.

Author

Uthman I, Almoallim H, Buckley CD, Masri B, Dahou-Makhloufi C, El Dershaby Y, Sunna N, Raza K, Kumar K, Abu-Saad Huijer H, Tashkandi N, Louw I, and Adelowo O

Subjects
Africa, Arthritis, Rheumatoid drug therapy, Delphi Technique, Female, Humans, Male, Middle East, Nurse Specialists supply & distribution, Patient Satisfaction, Rheumatology economics, Arthritis, Rheumatoid nursing, Nurse Specialists organization & administration, Practice Patterns, Nurses' organization & administration, Rheumatology organization & administration
Abstract

Globally, increasing demand for rheumatology services has led to a greater reliance on non-physician healthcare professionals (HCPs), such as rheumatology nurse specialists, to deliver care as part of a multidisciplinary team. Across Africa and the Middle East (AfME), there remains a shortage of rheumatology HCPs, including rheumatology nurses, which presents a major challenge to the delivery of rheumatology services, and subsequently the treatment and management of conditions such as rheumatoid arthritis (RA). To further explore the importance of nurse-led care (NLC) for patients with RA and create a set of proposed strategies for the implementation of NLC in the AfME region, we used a modified Delphi technique. A review of the global literature was conducted using the PubMed search engine, with the most relevant publications selected. The findings were summarized and presented to the author group, which was composed of representatives from different countries and HCP disciplines. The authors also drew on their knowledge of the wider literature to provide context. Overall, results suggest that NLC is associated with improved patient perceptions of RA care, and equivalent or superior clinical and cost outcomes versus physician-led care in RA disease management. Expert commentary provided by the authors gives insights into the challenges of implementing nurse-led RA care. We further report practical proposed strategies for the development and implementation of NLC for patients with RA, specifically in the AfME region. These proposed strategies aim to act as a foundation for the introduction and development of NLC programs across the AfME region.

Published
2021
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44. A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis.

Author

Polák P, Peric P, Louw I, Gaylord SM, Williams T, Becker JC, Pedersen R, Korth-Bradley J, and Vlahos B

Abstract

Objective: To evaluate the immunogenicity, safety, and efficacy of etanercept (ETN) manufactured using the serum-free, high-capacity manufacturing (SFHCM) process in patients with rheumatoid arthritis (RA)., Methods: In this global, multicenter, open-label, single-arm study (NCT02378506), 187 adult patients with moderate to severe RA received ETN 50 mg once weekly for 24 weeks manufactured using the SFHCM process. Immunogenicity (presence of antidrug antibodies (ADAs) and neutralizing antibodies (NAbs)) was assessed at 12 and 24 weeks. Safety and efficacy were evaluated at 4, 12, and 24 weeks., Results: Eight (4.5%) patients tested positive for ADA, and there were no NAbs detected at any time throughout the study. Ninety (48.1%) patients reported treatment-emergent adverse events (AEs), of which 27 (14.4%) reported injection-site reactions, and 43 (23.0%) reported infections. The majority of AEs were mild or moderate in severity, and the drug was well tolerated. Throughout the duration of the study (week 4 to week 24), there was a progressive increase in the American College of Rheumatology (ACR)-defined responses (ACR20: 55.9%-82.0%, ACR50: 16.1%-57.8%, and ACR70: 3.2%-26.7%) from baseline and the proportion of patients achieving low disease activity and remission, with a corresponding decrease in measures of disease activity., Conclusion: The immunogenicity, safety, and efficacy of ETN manufactured using the SFHCM process were similar to the current approved ETN formulation. ClinicalTrials.gov registration: NCT02378506.

Published
2019
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45. Diabetes screen during tuberculosis contact investigations highlights opportunity for new diabetes diagnosis and reveals metabolic differences between ethnic groups.

Author

Restrepo BI, Kleynhans L, Salinas AB, Abdelbary B, Tshivhula H, Aguillón-Durán GP, Kunsevi-Kilola C, Salinas G, Stanley K, Malherbe ST, Maasdorp E, Garcia-Viveros M, Louw I, Garcia-Oropesa EM, Lopez-Alvarenga JC, Prins JB, Walzl G, Schlesinger LS, and Ronacher K

Subjects
Adult, Aged, Biomarkers blood, Blood Glucose metabolism, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 diagnosis, Dyslipidemias blood, Dyslipidemias diagnosis, Female, Glycated Hemoglobin metabolism, Humans, Lipids blood, Male, Mexico epidemiology, Middle Aged, Prediabetic State blood, Prediabetic State diagnosis, Prediabetic State ethnology, Prevalence, South Africa epidemiology, Texas epidemiology, Tuberculosis blood, Tuberculosis diagnosis, Black or African American, Black People, Contact Tracing, Diabetes Mellitus, Type 2 ethnology, Dyslipidemias ethnology, Hispanic or Latino, Mass Screening methods, Tuberculosis ethnology
Abstract

Type 2 diabetes (T2D) is a prevalent risk factor for tuberculosis (TB), but most studies on TB-T2D have focused on TB patients, been limited to one community, and shown a variable impact of T2D on TB risk or treatment outcomes. We conducted a cross-sectional assessment of sociodemographic and metabolic factors in adult TB contacts with T2D (versus no T2D), from the Texas-Mexico border to study Hispanics, and in Cape Town to study South African Coloured ethnicities. The prevalence of T2D was 30.2% in Texas-Mexico and 17.4% in South Africa, with new diagnosis in 34.4% and 43.9%, respectively. Contacts with T2D differed between ethnicities, with higher smoking, hormonal contraceptive use and cholesterol levels in South Africa, and higher obesity in Texas-Mexico (p < 0.05). PCA analysis revealed striking differences between ethnicities in the relationships between factors defining T2D and dyslipidemias. Our findings suggest that screening for new T2D in adult TB contacts is effective to identify new T2D patients at risk for TB. Furthermore, studies aimed at predicting individual TB risk in T2D patients, should take into account the heterogeneity in dyslipidemias that are likely to modify the estimates of TB risk or adverse treatment outcomes that are generally attributed to T2D alone., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2018
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46. Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab.

Author

Vastesaeger N, Kutzbach AG, Amital H, Pavelka K, Lazaro MA, Moots RJ, Wollenhaupt J, Zerbini CA, Louw I, Combe B, Beaulieu A, Schulze-Koops H, Dasgupta B, Fu B, Huyck S, Weng HH, Govoni M, and Durez P

Subjects
Chronic Disease, Female, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Regression Analysis, Remission Induction, Treatment Outcome, Antibodies, Monoclonal therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy
Abstract

Objective: To create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice., Methods: We analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR <2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1., Results: In 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648-0.809 (R(2) = 0.0397-0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA., Conclusion: A matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Published
2016
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47. Patient and physician expectations of add-on treatment with golimumab for rheumatoid arthritis: relationships between expectations and clinical and quality of life outcomes.

Author

Dasgupta B, Combe B, Louw I, Wollenhaupt J, Zerbini CA, Beaulieu A, Schulze-Koops H, Durez P, Wolff V, Yao R, Weng HH, Govoni M, and Vastesaeger N

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Prospective Studies, Remission Induction, Severity of Illness Index, Sex Factors, Surveys and Questionnaires, Treatment Outcome, Young Adult, Antibodies, Monoclonal therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Patient Satisfaction, Quality of Life
Abstract

Objective: Rheumatoid arthritis (RA) management involves improving clinical outcomes and quality of life (QOL). Golimumab is used as add-on therapy for patients who have failed disease-modifying antirheumatic drugs (DMARDs). This GO-MORE subanalysis investigated relationships between patient and physician expectations and outcomes., Methods: GO-MORE was an open-label, multinational, prospective study in biologic agent-naive patients with active RA despite DMARD treatment. Patients received 50 mg subcutaneous golimumab monthly for 6 months. At baseline and month 3, patients rated treatment expectations for the following 3 months using 5-point scales (where 1 = good and 5 = poor). Outcomes were compared among expectation tertiles: most positive, intermediate, and least positive. At baseline and month 3, physicians predicted patient disease state 3 months later., Results: At baseline, 3,280 efficacy-evaluable patients with moderate (21.3%) or high (78.7%) disease activity had mean ± SD disease duration of 7.6 ± 7.9 years, mean ± SD Health Assessment Questionnaire (HAQ) disability index (DI) score of 1.44 ± 0.67, and mean ± SD EuroQol 5-domain (EQ-5D) score of 0.42 ± 0.33. Patients reported high treatment expectations (mean 1.43); 95.9% expected golimumab to be better than current treatment. Patients with fewer DMARD failures, higher disease activity, shorter disease duration, younger age, and female sex reported higher expectations (P < 0.05 for all). After 6 months, patients with the most positive expectations had higher remission rates (P < 0.0001) and greater HAQ DI (P < 0.0001) and EQ-5D (P < 0.0001) score improvements. At baseline, physicians expected 29.6% and 59.2% of patients to attain remission and low disease activity, respectively, after 3 months., Conclusion: Patients had high expectations for golimumab treatment. Patients with more positive expectations had greater remission rates, improvements in function, and QOL., (Copyright © 2014 by the American College of Rheumatology.)

Published
2014
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48. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study.

Author

Combe B, Dasgupta B, Louw I, Pal S, Wollenhaupt J, Zerbini CA, Beaulieu AD, Schulze-Koops H, Durez P, Yao R, Vastesaeger N, and Weng HH

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Drug Therapy, Combination, Female, Humans, Injections, Intravenous, Injections, Subcutaneous, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Treatment Outcome, Young Adult, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Antirheumatic Agents administration & dosage, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid drug therapy
Abstract

Objectives: To evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission., Methods: GO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received add-on monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)-erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured., Results: 3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population., Conclusions: Add-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Published
2014
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49. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study).

Author

Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, Pappu R, Delaet I, Pans M, and Ludivico C

Subjects
Abatacept, Adult, Antirheumatic Agents adverse effects, Antirheumatic Agents immunology, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid blood, Biomarkers blood, C-Reactive Protein metabolism, Drug Administration Schedule, Female, Humans, Immunoconjugates adverse effects, Immunoconjugates immunology, Immunoconjugates therapeutic use, Injections, Subcutaneous, Male, Middle Aged, Treatment Outcome, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy, Immunoconjugates administration & dosage, Withholding Treatment
Abstract

Objectives: To assess the effect of a temporary interruption in subcutaneous (SC) abatacept on immunogenicity, safety and efficacy in patients with active rheumatoid arthritis despite methotrexate in a phase III trial., Methods: Following a 12-week open-label introduction (period I; intravenous abatacept loading dose and weekly fixed-dose SC abatacept 125 mg), patients were randomised 2:1 to double-blind SC placebo or SC abatacept for 12 weeks (period II). At the end of period II, patients receiving SC abatacept continued treatment and patients on placebo were reintroduced to SC abatacept (12-week open-label period III). The co-primary end points were ELISA-detected immunogenicity rate and safety at the end of period II. Efficacy was also monitored., Results: Of 167 patients entering period I, 72% qualified for period II; during periods II and III, three patients discontinued treatment. Mean (SD) disease duration was 6.6 (6.5) years and Disease Activity Score 28 was 4.8 (0.8). The primary end point was met, with a non-significant increase in immunogenicity upon withdrawal (7/73 placebo vs 0/38 abatacept in period II; p=0.119) which was reversed upon reintroduction of SC abatacept (2/73 vs 1/38, end period III). Safety was comparable regardless of withdrawal, with no unexpected events upon reintroduction. Two patients experienced reactions at the SC injection site. On withdrawal, patients experienced slight worsening in efficacy which improved following reintroduction., Conclusions: Overall immunogenicity to SC abatacept is low, consistent with intravenous abatacept, and is not significantly affected by a 3-month interruption and reintroduction. This stop-start schedule was well tolerated, with little impact on safety and efficacy. These are important considerations for the clinical use of SC abatacept., Clinicaltrials: gov Identifier NCT00533897.

Published
2012
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50. Evaluation of the efficacy and safety of the Rift Valley Fever Clone 13 vaccine in sheep.

Author

Dungu B, Louw I, Lubisi A, Hunter P, von Teichman BF, and Bouloy M

Subjects
Animals, Antibodies, Neutralizing blood, Antibodies, Viral blood, Dose-Response Relationship, Immunologic, Female, Male, Pregnancy, Rift Valley Fever immunology, Sheep immunology, Sheep virology, Sheep Diseases immunology, Vaccines, Attenuated administration & dosage, Vaccines, Attenuated immunology, Viral Vaccines administration & dosage, Rift Valley Fever prevention & control, Rift Valley fever virus immunology, Sheep Diseases prevention & control, Vaccination veterinary, Viral Vaccines immunology
Abstract

The efficacy and safety of the naturally attenuated Rift Valley Fever (RVF) Clone 13 vaccine were evaluated in ovines in three different experiments involving 38 ewes at different stages of pregnancy, their offsprings and four rams. In Experiment 1, 4 rams and a total of 13 pregnant ewes were vaccinated and monitored during vaccination and after a challenge with a virulent RVF virus. The ewes were vaccinated at either 50 or 100 days of pregnancy and some were challenged after lambing. In Experiment 2, nine oestrus-synchronized ewes were vaccinated at 50 days of pregnancy and challenged at 100 days of pregnancy together with 5 unvaccinated ewes at the same stage of pregnancy. In Experiment 3, 16 oestrus-synchronized ewes were vaccinated with 3 different doses of the RVF Clone 13 vaccine and challenged together with unvaccinated pregnant ewes at either 30 or 50 days of pregnancy. The results from the three experiments indicated that the vaccine did not induce clinical manifestation of RVF such as abortion in pregnant ewes, teratogeny in their offsprings, or pyrexia in all vaccinated animals. Vaccination with RVF Clone 13 vaccine also prevented clinical RVF following virulent challenge at different stages of pregnancy while unvaccinated control ewes showed pyrexia, aborted or died of RVF. A vaccine dose-response effect was also observed., ((c) 2010 Elsevier Ltd. All rights reserved.)

Published
2010
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