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2. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

Author

Ahmed, Khalid, Alper, Jeffrey, Barkham, Nichol, Bennett, Ralph E., García, Francisco Javier Blanco, Alonso, Ricardo Blanco, Blumstein, Howard B., Brooks, Michael S., Burmester, Gerd-Rüdiger, Cagnoli, Patricia, Caldron, Paul H., Cantagrel, Alain, Chen, Der-Yuan, Churchill, Melvin A., Jr, Codding, Christine E., Combe, Benard, Deane, Peter M.G., Del Giudice, Jose, Deodhar, Atul A., Dhar, Rajat K., Dokoupilova, Eva, Egan, Rita M., Everding, Andrea, Galíndez, Eva, Genovese, Mark, Goddard, David H., Gottlieb, Alice, Goupille, Philippe, Griffin, Robert M., Gupta, Ramesh C., Hall, Stephen, Hatti, Kalpita, Howell, Mary P., Huang, Yu-Huei, Jajoo, Ramina, Janssen, Namieta M., Kiltz, Uta, Kivitz, Alan J., Klein, Steven J., Korkosz, Mariusz P., Kotha, Roshan, Kremer, Joel M., Lue, Cummins, de la Fuente, José Luis Marenco, Marzo-Ortega, Helena, Masmitja, Jordi Gratacós, Mease, Philip J., Meroni, Pier Luigi, Mueller, Eric C., Nandagudi, Anupama C., Nash, Peter, Fernández-Nebro, Antonio, Neuwelt, Clark M., Orbai, Ana Maria, Oza, Meera R., Parks, Deborah L., Pattanaik, Debendra, Rell-Bakalarska, Maria E., Rosmarin, David, Roussou, Euthalia, Rychlewska-Hanczewksa, Anna I., Sikes, David H., Stack, Michael T., Sunkureddi, Prashanth, Tahir, Hasan, Thaçi, Diamant, Tsai, Tsen-Fang, Turkiewicz, Anthony M., Unger, Leonore, Cabello, Raúl Veiga, Wagner, Ulf, Wei, Cheng-Chung, Wells, Alvin F., Youssef, Peter, Zielinska, Agnieszka, Kirkham, Bruce, Okada, Masato, Rahman, Proton, Burmester, Gerd-Ruediger, Adams, David H, Kerr, Lisa, Lee, Chin, and Shuler, Catherine L

Published
2017
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5. Oral abstracts 3: RA Treatment and outcomesO13. Validation of jadas in all subtypes of juvenile idiopathic arthritis in a clinical setting

Author

McErlane, Flora, Beresford, Michael W., Baildam, Eileen M., Thomson, Wendy, Hyrich, Kimme, Chieng, Alice, Davidson, Joyce, Foster, Helen E., Gardner-Medwin, Janet, Lunt, Mark, Wedderburn, Lucy, Nikiphorou, Elena, Carpenter, Lewis, Kiely, Patrick, Walsh, David, Dixey, Josh, Young, Adam, Kapoor, Sabrina R., Filer, Andrew, Fitzpatrick, Martin, Fisher, Benjamin A., Taylor, Peter C., Buckley, Christopher, McInnes, Iain, Raza, Karim, Young, Stephen P., Dougados, Maxime, Kissel, Karsten, Amital, Howard, Conaghan, Philip, Martin-Mola, Emilio, Nasonov, Evgeny, Schett, Georg, Troum, Orrin, Veldi, Tiina, Bernasconi, Corrado, Huizinga, Tom, Durez, Patrick, Genovese, Mark C., Richards, Hanno B., Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A., Lee, Sang-Heon, Codding, Christine E., Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, Kavanaugh, Arthur, Emery, Paul, Fleischmann, Roy, Van Vollenhoven, Ronald, Pavelka, Karel, Guérette, Benoît, Santra, Sourav, Redden, Laura, Kupper, Hartmut, Smolen, Josef S., Wilkie, Ross, Tajar, Abdelouahid, McBeth, John, Hooper, Lindsey S., Bowen, Catherine J., Gates, Lucy, Culliford, David, Edwards, Christopher J., Arden, Nigel K., Adams, Jo, Ryan, Sarah, Haywood, Hannah, Pain, Helen, Siddle, Heidi J., Redmond, Anthony C., Waxman, Robin, Dagg, Abigail R., Alcacer-Pitarch, Begonya, Wilkins, Richard A., Helliwell, Philip S., Norton, Sam, Williams, Richard, Halls, Serena, Law, Rebecca-Jane, Jones, Jeremy, Markland, David, Maddison, Peter, Thom, Jeanette, Parker, Ben, Urowitz, Murray B., Gladman, Dafna D., Bruce, Ian, Croca, Sara C., Pericleous, Charis, Yong, Harry, Isenberg, David, Giles, Ian, Rahman, Anisur, Ioannou, Yiannis, Warrell, Clare E., Dobarro, David, Handler, Clive, Denton, Christopher P., Schreiber, Benjamin E., Coghlan, John G., Betteridge, Zoe E., Woodhead, Felix, Bunn, Christopher, Abraham, David, Desai, Sujal, du Bois, Roland, Wells, Athol, McHugh, Neil, Abignano, Giuseppina, Aydin, Sibel, Castillo-Gallego, Conception, Woods, Daniel, Meekings, Adam, McGonagle, Dennis, Del Galdo, Francesco, Vila, Josephine, Mitchell, Sheryl, Bowman, Simon, Price, Elizabeth, Pease, Colin T., Andrews, Jacqueline, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Constantino, Lanyon, Peter, Hunter, John, Gupta, Monica, McLaren, John, Regan, Marian, Cooper, Annie, Vadivelu, Saravanan, Coady, David, Griffiths, Bridget, Lendrem, Dennis, Foggo, Heather, Tarn, Jessica, Ng, Wan-Fai, Goodhead, Charlotte, Shekar, Priya, Kelly, Clive, Francis, Gail, Bailey, Ann-Marie, Thompson, Lynsey, Hamilton, Jennifer, Salisbury, Chris, Foster, Nadine E., Bishop, Annette, Coast, Jo, Franchini, Angelo, Hall, Jeanette, Hollinghurst, Sandra, Hopper, Cherida, Grove, Sean, Kaur, Surinder, Montgomery, Alan, Paskins, Zoe, Sanders, Tom, Croft, Peter R., Hassell, Andy B., Coxon, Domenica E., Frisher, Martin, Jordan, Kelvin P., Jinks, Clare, Peat, George, Monk, Helen L., Muller, Sara, Mallen, Christian, Hider, Samantha L., Roddy, Edward, and Hayward, Richard

Abstract

Background: Juvenile Arthritis Disease Activity Score (JADAS) is a 4 variable composite disease activity (DA) score for JIA (including active 10, 27 or 71 joint count (AJC), physician global (PGA), parent/child global (PGE) and ESR). The validity of JADAS for all ILAR subtypes in the routine clinical setting is unknown. We investigated the construct validity of JADAS in the clinical setting in all subtypes of JIA through application to a prospective inception cohort of UK children presenting with new onset inflammatory arthritis. Methods: JADAS 10, 27 and 71 were determined for all children in the Childhood Arthritis Prospective Study (CAPS) with complete data available at baseline. Correlation of JADAS 10, 27 and 71 with single DA markers was determined for all subtypes. All correlations were calculated using Spearman's rank statistic. Results: 262/1238 visits had sufficient data for calculation of JADAS (1028 (83%) AJC, 744 (60%) PGA, 843 (68%) PGE and 459 (37%) ESR). Median age at disease onset was 6.0 years (IQR 2.6-10.4) and 64% were female. Correlation between JADAS 10, 27 and 71 approached 1 for all subtypes. Median JADAS 71 was 5.3 (IQR 2.2-10.1) with a significant difference between median JADAS scores between subtypes (p < 0.01). Correlation of JADAS 71 with each single marker of DA was moderate to high in the total cohort (see Table 1). Overall, correlation with AJC, PGA and PGE was moderate to high and correlation with ESR, limited JC, parental pain and CHAQ was low to moderate in the individual subtypes. Correlation coefficients in the extended oligoarticular, rheumatoid factor negative and enthesitis related subtypes were interpreted with caution in view of low numbers. Conclusions: This study adds to the body of evidence supporting the construct validity of JADAS. JADAS correlates with other measures of DA in all ILAR subtypes in the routine clinical setting. Given the high frequency of missing ESR data, it would be useful to assess the validity of JADAS without inclusion of the ESR. Disclosure statement: All authors have declared no conflicts of interest. Table 1Spearman's correlation between JADAS 71 and single markers DA by ILAR subtype ILAR Subtype Systemic onset JIA Persistent oligo JIA Extended oligo JIA Rheumatoid factor neg JIA Rheumatoid factor pos JIA Enthesitis related JIA Psoriatic JIA Undifferentiated JIA Unknown subtype Total cohort Number of children 23 111 12 57 7 9 19 7 17 262 AJC 0.54 0.67 0.53 0.75 0.53 0.34 0.59 0.81 0.37 0.59 PGA 0.63 0.69 0.25 0.73 0.14 0.05 0.50 0.83 0.56 0.64 PGE 0.51 0.68 0.83 0.61 0.41 0.69 0.71 0.9 0.48 0.61 ESR 0.28 0.31 0.35 0.4 0.6 0.85 0.43 0.7 0.5 0.53 Limited 71 JC 0.29 0.51 0.23 0.37 0.14 -0.12 0.4 0.81 0.45 0.41 Parental pain 0.23 0.62 0.03 0.57 0.41 0.69 0.7 0.79 0.42 0.53 Childhood health assessment questionnaire 0.25 0.57 -0.07 0.36 -0.47 0.84 0.37 0.8 0.66 0.47

Published
2017

6. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

Author

Nash, Peter, primary, Kirkham, Bruce, additional, Okada, Masato, additional, Rahman, Proton, additional, Combe, Benard, additional, Burmester, Gerd-Ruediger, additional, Adams, David H, additional, Kerr, Lisa, additional, Lee, Chin, additional, Shuler, Catherine L, additional, Genovese, Mark, additional, Ahmed, Khalid, additional, Alper, Jeffrey, additional, Barkham, Nichol, additional, Bennett, Ralph E., additional, García, Francisco Javier Blanco, additional, Alonso, Ricardo Blanco, additional, Blumstein, Howard B., additional, Brooks, Michael S., additional, Burmester, Gerd-Rüdiger, additional, Cagnoli, Patricia, additional, Caldron, Paul H., additional, Cantagrel, Alain, additional, Chen, Der-Yuan, additional, Churchill, Melvin A., additional, Codding, Christine E., additional, Deane, Peter M.G., additional, Del Giudice, Jose, additional, Deodhar, Atul A., additional, Dhar, Rajat K., additional, Dokoupilova, Eva, additional, Egan, Rita M., additional, Everding, Andrea, additional, Galíndez, Eva, additional, Goddard, David H., additional, Gottlieb, Alice, additional, Goupille, Philippe, additional, Griffin, Robert M., additional, Gupta, Ramesh C., additional, Hall, Stephen, additional, Hatti, Kalpita, additional, Howell, Mary P., additional, Huang, Yu-Huei, additional, Jajoo, Ramina, additional, Janssen, Namieta M., additional, Kiltz, Uta, additional, Kivitz, Alan J., additional, Klein, Steven J., additional, Korkosz, Mariusz P., additional, Kotha, Roshan, additional, Kremer, Joel M., additional, Lue, Cummins, additional, de la Fuente, José Luis Marenco, additional, Marzo-Ortega, Helena, additional, Masmitja, Jordi Gratacós, additional, Mease, Philip J., additional, Meroni, Pier Luigi, additional, Mueller, Eric C., additional, Nandagudi, Anupama C., additional, Nash, Peter, additional, Fernández-Nebro, Antonio, additional, Neuwelt, Clark M., additional, Orbai, Ana Maria, additional, Oza, Meera R., additional, Parks, Deborah L., additional, Pattanaik, Debendra, additional, Rell-Bakalarska, Maria E., additional, Rosmarin, David, additional, Roussou, Euthalia, additional, Rychlewska-Hanczewksa, Anna I., additional, Sikes, David H., additional, Stack, Michael T., additional, Sunkureddi, Prashanth, additional, Tahir, Hasan, additional, Thaçi, Diamant, additional, Tsai, Tsen-Fang, additional, Turkiewicz, Anthony M., additional, Unger, Leonore, additional, Cabello, Raúl Veiga, additional, Wagner, Ulf, additional, Wei, Cheng-Chung, additional, Wells, Alvin F., additional, Youssef, Peter, additional, and Zielinska, Agnieszka, additional

Published
2017
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7. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study.

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, and Mpofu, Shephard

Abstract

OBJECTIVE: To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis. METHODS: In this 52-week, double-blind, placebo-controlled (up to Week 20) study (NCT00928512), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety results up to Week 20 have been reported previously. Here, efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented. RESULTS: Of 237 patients randomized, 174 (73.4%) completed the study. Patients with improved American College of Rheumatology (ACR) and 28-joint Disease Activity Score (DAS28) C-reactive protein (CRP) responses at Week 16 sustained their responses through Week 52. In patients taking 150 mg of secukinumab, responses were improved through Week 52 (ACR50: Week 16 = 45%, Week 52 = 55%; DAS28-CRP ≤ 2.6: Week 16 = 25%, Week 52 = 40%). The rate of adverse events (AE) from weeks 20 to 60 was 64.8%, with most AE being mild to moderate in severity. The overall rate of infections was 31.9%, most being mild. The most predominant infection was nasopharyngitis, and was not associated with dose or concurrent neutropenia. Serious AE were reported in 21 patients (8.9%). There were 3 reports of malignancies (ovarian, lung, basal cell), and no deaths between weeks 20 and 60. CONCLUSION: Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab. The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks.

Published
2014

8. One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study

Author

Genovese, Mark C., primary, Durez, Patrick, additional, Richards, Hanno B., additional, Supronik, Jerzy, additional, Dokoupilova, Eva, additional, Aelion, Jacob A., additional, Lee, Sang-Heon, additional, Codding, Christine E., additional, Kellner, Herbert, additional, Ikawa, Takashi, additional, Hugot, Sophie, additional, Ligozio, Gregory, additional, and Mpofu, Shephard, additional

Published
2014
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9. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Mazurov, Vadim, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Mpofu, Shephard, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Mazurov, Vadim, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, and Mpofu, Shephard

Abstract

OBJECTIVE: To assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleukin-17A antibody, in patients with rheumatoid arthritis (RA). METHODS: Patients (n=237) with inadequate response to methotrexate were randomly assigned to receive monthly subcutaneous injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. The primary endpoint was the American College of Rheumatology 20% response (ACR20) at week 16. RESULTS: Demographics and baseline characteristics were comparable across all treatment groups. The primary efficacy endpoint was not achieved: the proportion of ACR20 responders at week 16 with secukinumab 25-300 mg was 36.0-53.7% versus placebo (34%). Disease activity score in 28 joints (DAS28)-C-reactive protein (CRP) was a secondary endpoint and clinically relevant decreases with secukinumab 75-300 mg were reported versus placebo. Serum high sensitivity CRP levels at week 16 were significantly reduced with secukinumab 75 mg, 150 mg and 300 mg doses versus placebo. The safety profile of secukinumab was consistent with that seen with other biological agents. Most adverse events (AE) were mild to moderate in severity. Infections were slightly more frequent with secukinumab than placebo. Six serious AE were reported: secukinumab 75 mg (one), secukinumab 300 mg (four) and placebo (one). CONCLUSIONS: ACR20 response rates differed between secukinumab 75 mg, 150 mg and 300 mg doses and placebo; however, the primary efficacy endpoint was not achieved. Greater decreases in DAS28 were observed with secukinumab 75 mg, 150 mg and 300 mg than placebo. There were no unexpected safety signals and no specific organ-related toxicities. Further trials with secukinumab in the treatment of RA are warranted.

Published
2013

10. Effect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASURE, a randomised, placebo-controlled study

Author

McInnes, Iain B, primary, Thompson, Liz, additional, Giles, Jon T, additional, Bathon, Joan M, additional, Salmon, Jane E, additional, Beaulieu, Andre D, additional, Codding, Christine E, additional, Carlson, Timothy H, additional, Delles, Christian, additional, Lee, Janet S, additional, and Sattar, Naveed, additional

Published
2013
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11. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Author

Genovese, Mark C, primary, Durez, Patrick, additional, Richards, Hanno B, additional, Supronik, Jerzy, additional, Dokoupilova, Eva, additional, Mazurov, Vadim, additional, Aelion, Jacob A, additional, Lee, Sang-Heon, additional, Codding, Christine E, additional, Kellner, Herbert, additional, Ikawa, Takashi, additional, Hugot, Sophie, additional, and Mpofu, Shephard, additional

Published
2012
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12. Oral abstracts 3: RA Treatment and outcomesO13. Validation of jadas in all subtypes of juvenile idiopathic arthritis in a clinical setting

Author

McErlane, Flora, Beresford, Michael W., Baildam, Eileen M., Thomson, Wendy, Hyrich, Kimme, Chieng, Alice, Davidson, Joyce, Foster, Helen E., Gardner-Medwin, Janet, Lunt, Mark, Wedderburn, Lucy, Nikiphorou, Elena, Carpenter, Lewis, Kiely, Patrick, Walsh, David, Dixey, Josh, Young, Adam, Kapoor, Sabrina R., Filer, Andrew, Fitzpatrick, Martin, Fisher, Benjamin A., Taylor, Peter C., Buckley, Christopher, McInnes, Iain, Raza, Karim, Young, Stephen P., Dougados, Maxime, Kissel, Karsten, Amital, Howard, Conaghan, Philip, Martin-Mola, Emilio, Nasonov, Evgeny, Schett, Georg, Troum, Orrin, Veldi, Tiina, Bernasconi, Corrado, Huizinga, Tom, Durez, Patrick, Genovese, Mark C., Richards, Hanno B., Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A., Lee, Sang-Heon, Codding, Christine E., Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, Kavanaugh, Arthur, Emery, Paul, Fleischmann, Roy, Van Vollenhoven, Ronald, Pavelka, Karel, Guérette, Benoît, Santra, Sourav, Redden, Laura, Kupper, Hartmut, Smolen, Josef S., Wilkie, Ross, Tajar, Abdelouahid, McBeth, John, Hooper, Lindsey S., Bowen, Catherine J., Gates, Lucy, Culliford, David, Edwards, Christopher J., Arden, Nigel K., Adams, Jo, Ryan, Sarah, Haywood, Hannah, Pain, Helen, Siddle, Heidi J., Redmond, Anthony C., Waxman, Robin, Dagg, Abigail R., Alcacer-Pitarch, Begonya, Wilkins, Richard A., Helliwell, Philip S., Norton, Sam, Williams, Richard, Halls, Serena, Law, Rebecca-Jane, Jones, Jeremy, Markland, David, Maddison, Peter, Thom, Jeanette, Parker, Ben, Urowitz, Murray B., Gladman, Dafna D., Bruce, Ian, Croca, Sara C., Pericleous, Charis, Yong, Harry, Isenberg, David, Giles, Ian, Rahman, Anisur, Ioannou, Yiannis, Warrell, Clare E., Dobarro, David, Handler, Clive, Denton, Christopher P., Schreiber, Benjamin E., Coghlan, John G., Betteridge, Zoe E., Woodhead, Felix, Bunn, Christopher, Abraham, David, Desai, Sujal, du Bois, Roland, Wells, Athol, McHugh, Neil, Abignano, Giuseppina, Aydin, Sibel, Castillo-Gallego, Conception, Woods, Daniel, Meekings, Adam, McGonagle, Dennis, Del Galdo, Francesco, Vila, Josephine, Mitchell, Sheryl, Bowman, Simon, Price, Elizabeth, Pease, Colin T., Andrews, Jacqueline, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Constantino, Lanyon, Peter, Hunter, John, Gupta, Monica, McLaren, John, Regan, Marian, Cooper, Annie, Vadivelu, Saravanan, Coady, David, Griffiths, Bridget, Lendrem, Dennis, Foggo, Heather, Tarn, Jessica, Ng, Wan-Fai, Goodhead, Charlotte, Shekar, Priya, Kelly, Clive, Francis, Gail, Bailey, Ann-Marie, Thompson, Lynsey, Hamilton, Jennifer, Salisbury, Chris, Foster, Nadine E., Bishop, Annette, Coast, Jo, Franchini, Angelo, Hall, Jeanette, Hollinghurst, Sandra, Hopper, Cherida, Grove, Sean, Kaur, Surinder, Montgomery, Alan, Paskins, Zoe, Sanders, Tom, Croft, Peter R., Hassell, Andy B., Coxon, Domenica E., Frisher, Martin, Jordan, Kelvin P., Jinks, Clare, Peat, George, Monk, Helen L., Muller, Sara, Mallen, Christian, Hider, Samantha L., Roddy, Edward, Hayward, Richard, McErlane, Flora, Beresford, Michael W., Baildam, Eileen M., Thomson, Wendy, Hyrich, Kimme, Chieng, Alice, Davidson, Joyce, Foster, Helen E., Gardner-Medwin, Janet, Lunt, Mark, Wedderburn, Lucy, Nikiphorou, Elena, Carpenter, Lewis, Kiely, Patrick, Walsh, David, Dixey, Josh, Young, Adam, Kapoor, Sabrina R., Filer, Andrew, Fitzpatrick, Martin, Fisher, Benjamin A., Taylor, Peter C., Buckley, Christopher, McInnes, Iain, Raza, Karim, Young, Stephen P., Dougados, Maxime, Kissel, Karsten, Amital, Howard, Conaghan, Philip, Martin-Mola, Emilio, Nasonov, Evgeny, Schett, Georg, Troum, Orrin, Veldi, Tiina, Bernasconi, Corrado, Huizinga, Tom, Durez, Patrick, Genovese, Mark C., Richards, Hanno B., Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A., Lee, Sang-Heon, Codding, Christine E., Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, Kavanaugh, Arthur, Emery, Paul, Fleischmann, Roy, Van Vollenhoven, Ronald, Pavelka, Karel, Guérette, Benoît, Santra, Sourav, Redden, Laura, Kupper, Hartmut, Smolen, Josef S., Wilkie, Ross, Tajar, Abdelouahid, McBeth, John, Hooper, Lindsey S., Bowen, Catherine J., Gates, Lucy, Culliford, David, Edwards, Christopher J., Arden, Nigel K., Adams, Jo, Ryan, Sarah, Haywood, Hannah, Pain, Helen, Siddle, Heidi J., Redmond, Anthony C., Waxman, Robin, Dagg, Abigail R., Alcacer-Pitarch, Begonya, Wilkins, Richard A., Helliwell, Philip S., Norton, Sam, Williams, Richard, Halls, Serena, Law, Rebecca-Jane, Jones, Jeremy, Markland, David, Maddison, Peter, Thom, Jeanette, Parker, Ben, Urowitz, Murray B., Gladman, Dafna D., Bruce, Ian, Croca, Sara C., Pericleous, Charis, Yong, Harry, Isenberg, David, Giles, Ian, Rahman, Anisur, Ioannou, Yiannis, Warrell, Clare E., Dobarro, David, Handler, Clive, Denton, Christopher P., Schreiber, Benjamin E., Coghlan, John G., Betteridge, Zoe E., Woodhead, Felix, Bunn, Christopher, Abraham, David, Desai, Sujal, du Bois, Roland, Wells, Athol, McHugh, Neil, Abignano, Giuseppina, Aydin, Sibel, Castillo-Gallego, Conception, Woods, Daniel, Meekings, Adam, McGonagle, Dennis, Del Galdo, Francesco, Vila, Josephine, Mitchell, Sheryl, Bowman, Simon, Price, Elizabeth, Pease, Colin T., Andrews, Jacqueline, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Constantino, Lanyon, Peter, Hunter, John, Gupta, Monica, McLaren, John, Regan, Marian, Cooper, Annie, Vadivelu, Saravanan, Coady, David, Griffiths, Bridget, Lendrem, Dennis, Foggo, Heather, Tarn, Jessica, Ng, Wan-Fai, Goodhead, Charlotte, Shekar, Priya, Kelly, Clive, Francis, Gail, Bailey, Ann-Marie, Thompson, Lynsey, Hamilton, Jennifer, Salisbury, Chris, Foster, Nadine E., Bishop, Annette, Coast, Jo, Franchini, Angelo, Hall, Jeanette, Hollinghurst, Sandra, Hopper, Cherida, Grove, Sean, Kaur, Surinder, Montgomery, Alan, Paskins, Zoe, Sanders, Tom, Croft, Peter R., Hassell, Andy B., Coxon, Domenica E., Frisher, Martin, Jordan, Kelvin P., Jinks, Clare, Peat, George, Monk, Helen L., Muller, Sara, Mallen, Christian, Hider, Samantha L., Roddy, Edward, and Hayward, Richard

Abstract

Background: Juvenile Arthritis Disease Activity Score (JADAS) is a 4 variable composite disease activity (DA) score for JIA (including active 10, 27 or 71 joint count (AJC), physician global (PGA), parent/child global (PGE) and ESR). The validity of JADAS for all ILAR subtypes in the routine clinical setting is unknown. We investigated the construct validity of JADAS in the clinical setting in all subtypes of JIA through application to a prospective inception cohort of UK children presenting with new onset inflammatory arthritis. Methods: JADAS 10, 27 and 71 were determined for all children in the Childhood Arthritis Prospective Study (CAPS) with complete data available at baseline. Correlation of JADAS 10, 27 and 71 with single DA markers was determined for all subtypes. All correlations were calculated using Spearman's rank statistic. Results: 262/1238 visits had sufficient data for calculation of JADAS (1028 (83%) AJC, 744 (60%) PGA, 843 (68%) PGE and 459 (37%) ESR). Median age at disease onset was 6.0 years (IQR 2.6-10.4) and 64% were female. Correlation between JADAS 10, 27 and 71 approached 1 for all subtypes. Median JADAS 71 was 5.3 (IQR 2.2-10.1) with a significant difference between median JADAS scores between subtypes (p < 0.01). Correlation of JADAS 71 with each single marker of DA was moderate to high in the total cohort (see Table 1). Overall, correlation with AJC, PGA and PGE was moderate to high and correlation with ESR, limited JC, parental pain and CHAQ was low to moderate in the individual subtypes. Correlation coefficients in the extended oligoarticular, rheumatoid factor negative and enthesitis related subtypes were interpreted with caution in view of low numbers. Conclusions: This study adds to the body of evidence supporting the construct validity of JADAS. JADAS correlates with other measures of DA in all ILAR subtypes in the routine clinical setting. Given the high frequency of missing ESR data, it would be useful to assess the validity of JA

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