33 results on '"Gladman, Dafna D"'
Search Results
2. Use of Apremilast to Achieve Psoriatic Arthritis Treatment Goals and Satisfaction at 1 Year in the Canadian Real-World APPRAISE Study
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Chandran, Vinod, Bessette, Louis, Thorne, Carter, Sheriff, Maqbool, Rahman, Proton, Gladman, Dafna D., Anwar, Sabeen, Jelley, Jennifer, Gaudreau, Anne-Julie, Chohan, Manprit, and Sampalis, John S.
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- 2024
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3. Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis
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Curtis, Jeffrey R., McInnes, Iain B., Rahman, Proton, Gladman, Dafna D., Peterson, Steven, Yang, Feifei, Adejoro, Oluwakayode, Kollmeier, Alexa P., Shiff, Natalie J., Han, Chenglong, Shawi, May, Tillett, William, and Mease, Philip J.
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- 2024
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4. Generalized pustular psoriasis: A consensus statement from the National Psoriasis Foundation
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Calabrese, Cassandra, Desai, Seemal R., Duffin, Kristina C., Feldman, Steven R., Gladman, Dafna D., Glick, Brad P., Han, George, Harris, Jason, Hawkes, Jason E., Hsu, Sylvia, Huang, Margaret Y., Kalb, Robert E., Kircik, Leon H., Koo, John, Lewitt, G. Michael, Liao, Wilson J., Liu, Clive, Merola, Joseph F., Prussick, Ronald B., Reddy, Soumya M., Schwartzman, Sergio, Smith, Jessica N., Soung, Jennifer, Van Voorhees, Abby S., Wallace, Elizabeth B., Weinberg, Jeffrey M., Lee, Lara Wine, Yamauchi, Paul S., Armstrong, April W., Elston, Carly A., Elewski, Boni E., Ferris, Laura K., Gottlieb, Alice B., and Lebwohl, Mark G.
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- 2024
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5. Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses
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FitzGerald, Oliver, primary, Gladman, Dafna D., additional, Mease, Philip J., additional, Ritchlin, Christopher, additional, Smolen, Josef S., additional, Gao, Lu, additional, Hu, Yanhua, additional, Nowak, Miroslawa, additional, Banerjee, Subhashis, additional, and Catlett, Ian, additional
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- 2024
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6. BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies
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Baraliakos, Xenofon, primary, Gladman, Dafna D, additional, Chakravarty, Soumya D, additional, Gong, Cinty, additional, Shawi, May, additional, Rampakakis, Emmanouil, additional, Kishimoto, Mitsumasa, additional, Soriano, Enrique R, additional, and Mease, Philip J, additional
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- 2024
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7. Anti-KIF20B autoantibodies are associated with cranial neuropathy in systemic lupus erythematosus
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Krustev, Eugene, primary, Hanly, John G, additional, Chin, Ricky, additional, Buhler, Katherine A, additional, Urowitz, Murray B, additional, Gordon, Caroline, additional, Bae, Sang-Cheol, additional, Romero-Diaz, Juanita, additional, Sánchez-Guerrero, Jorge, additional, Bernatsky, Sasha, additional, Wallace, Daniel J, additional, Isenberg, David, additional, Rahman, Anisur, additional, Merrill, Joan T, additional, Fortin, Paul R, additional, Gladman, Dafna D, additional, Bruce, Ian N, additional, Petri, Michelle A, additional, Ginzler, Ellen M, additional, Dooley, Mary Anne, additional, Ramsey-Goldman, Rosalind, additional, Manzi, Susan, additional, Jönsen, Andreas, additional, Alarcón, Graciela S, additional, van Vollenhoven, Ronald F, additional, Aranow, Cynthia, additional, Mackay, Meggan, additional, Ruiz-Irastorza, Guillermo, additional, Lim, Sam, additional, Inanc, Murat, additional, Kalunian, Kenneth C, additional, Jacobsen, Søren, additional, Peschken, Christine A, additional, Kamen, Diane L, additional, Askenase, Anca, additional, Buyon, Jill, additional, Fritzler, Marvin J, additional, Clarke, Ann E, additional, and Choi, May Y, additional
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- 2024
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8. Comparative efficacy and safety of bimekizumab in psoriatic arthritis: a systematic literature review and network meta-analysis.
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Mease, Philip J, Gladman, Dafna D, Merola, Joseph F, Nash, Peter, Grieve, Stacy, Laliman-Khara, Victor, Willems, Damon, Taieb, Vanessa, Prickett, Adam R, and Coates, Laura C
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THERAPEUTIC use of immunoglobulins , *THERAPEUTIC use of monoclonal antibodies , *MEDICAL information storage & retrieval systems , *ANTI-inflammatory agents , *PATIENT safety , *PSORIATIC arthritis , *LEFLUNOMIDE , *METHOTREXATE , *ANTIRHEUMATIC agents , *META-analysis , *DESCRIPTIVE statistics , *SYSTEMATIC reviews , *ODDS ratio , *MEDLINE , *JANUS kinases , *PHOSPHODIESTERASE inhibitors , *DRUG efficacy , *MEDICAL databases , *SULFONAMIDES , *NEUROTRANSMITTER uptake inhibitors , *INTERLEUKINS , *CHEMICAL inhibitors - Abstract
Objectives To understand the relative efficacy and safety of bimekizumab, a selective inhibitor of IL-17F in addition to IL-17A, vs other biologic and targeted synthetic DMARDs (b/tsDMARDs) for PsA using network meta-analysis (NMA). Methods A systematic literature review (most recent update conducted on 1 January 2023) identified randomized controlled trials (RCTs) of b/tsDMARDs in PsA. Bayesian NMAs were conducted for efficacy outcomes at Weeks 12–24 for b/tsDMARD-naïve and TNF inhibitor (TNFi)-experienced patients. Safety at Weeks 12–24 was analysed in a mixed population. Odds ratios (ORs) and differences of mean change with the associated 95% credible interval (CrI) were calculated for the best-fitting models, and the surface under the cumulative ranking curve (SUCRA) values were calculated to determine relative rank. Results The NMA included 41 RCTs for 22 b/tsDMARDs. For minimal disease activity (MDA), bimekizumab ranked 1st in b/tsDMARD-naïve patients and 2nd in TNFi-experienced patients. In b/tsDMARD-naïve patients, bimekizumab ranked 6th, 5th and 3rd for ACR response ACR20/50/70, respectively. In TNFi-experienced patients, bimekizumab ranked 1st, 2nd and 1st for ACR20/50/70, respectively. For Psoriasis Area and Severity Index 90/100, bimekizumab ranked 2nd and 1st in b/tsDMARD-naïve patients, respectively, and 1st and 2nd in TNFi-experienced patients, respectively. Bimekizumab was comparable to b/tsDMARDs for serious adverse events. Conclusion Bimekizumab ranked favourably among b/tsDMARDs for efficacy on joint, skin and MDA outcomes, and showed comparable safety, suggesting it may be a beneficial treatment option for patients with PsA. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Incidence and predictors of demyelinating disease in spondyloarthritis: data from a longitudinal cohort study.
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Remalante-Rayco, Patricia, Espiritu, Adrian I, Daghistani, Yassir, Chim, Tina, Atenafu, Eshetu, Keshavarzi, Sareh, Jha, Mayank, Gladman, Dafna D, Oh, Jiwon, Haroon, Nigil, and Inman, Robert D
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INFLAMMATORY bowel disease diagnosis ,RISK assessment ,PSORIATIC arthritis ,PREDICTION models ,ANKYLOSIS ,SMOKING ,SCIENTIFIC observation ,DESCRIPTIVE statistics ,LONGITUDINAL method ,DEMYELINATION ,SPONDYLOARTHROPATHIES ,CONFIDENCE intervals ,PROPORTIONAL hazards models ,DISEASE risk factors - Abstract
Objectives The objectives of this study were to investigate the incidence of demyelinating disease (DD) among SpA patients and to identify risk factors that predict DD in this patient population. Methods Axial SpA (axSpA) and PsA patients were identified from a longitudinal cohort database. Each group was analysed according to the presence or absence of DD. Incidence rates (IRs) of DD were obtained, with competing risk analysis. Cox regression analysis (with Fine and Gray's method) was used to evaluate predictors of DD development. Results Among 2260 patients with follow-up data, we identified 18 DD events, corresponding to an average IR of 31 per 100 000 persons per year for SpA. The IR of DD at 20 years was higher in axSpA than in PsA (1.30% vs 0.13%, P = 0.01). The risk factors retained in the best predictive model for DD development included ever- (vs never-) smoking [hazard ratio (HR) 2.918, 95% CI 1.037–8.214, P = 0.0426], axSpA (vs PsA) (HR 8.790, 95% CI 1.242–62.182, P = 0.0294) and presence (vs absence) of IBD (HR 5.698, 95% CI 2.083–15.589, P = 0.0007). History of TNF-α inhibitor therapy was not a predictor of DD. Conclusion The overall incidence of DD in this SpA cohort was low. Incident DD was higher in axSpA than in PsA. A diagnosis of axSpA, the presence of IBD, and ever-smoking predicted the development of DD. History of TNF-α inhibitor use was not found to be a predictor of DD in this cohort. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Residual Disease Activity In Canadian Patients With Psoriatic Arthritis (PsA) Treated With Advanced Therapies: Results From A Multi-Registry Analysis (UNISON-PsA)
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Gladman, Dafna D., primary, Chandran, Vinod, additional, Rosen, Cheryl F., additional, Rohekar, Sherry, additional, Boyd, Tristan, additional, Eder, Lihi, additional, Rahman, Proton, additional, Dutz, Jan, additional, Chan, Jonathan, additional, Haydey, Richard P., additional, Barac, Snezana, additional, Laliberté, Marie-Claude, additional, Girard, Tanya, additional, Fournier, Pierre-André, additional, Sutton, Mitchell, additional, Pereira, Daniel, additional, Chim, Tina, additional, Coupal, Louis, additional, and Choquette, Denis, additional
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- 2024
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11. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL
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Coates, Laura C, primary, Landewé, Robert, additional, McInnes, Iain B, additional, Mease, Philip J, additional, Ritchlin, Christopher T, additional, Tanaka, Yoshiya, additional, Asahina, Akihiko, additional, Behrens, Frank, additional, Gladman, Dafna D, additional, Gossec, Laure, additional, Orbai, Ana-Maria, additional, Gottlieb, Alice B, additional, Warren, Richard B, additional, Ink, Barbara, additional, Bajracharya, Rajan, additional, Shende, Vishvesh, additional, Coarse, Jason, additional, and Merola, Joseph F, additional
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- 2024
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12. Serum S100A8/A9 and MMP-9 levels are elevated in systemic lupus erythematosus patients with cognitive impairment
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Muñoz-Grajales, Carolina, primary, Barraclough, Michelle L., additional, Diaz-Martinez, Juan P., additional, Su, Jiandong, additional, Bingham, Kathleen, additional, Kakvan, Mahta, additional, Kretzmann, Roberta Pozzi, additional, Tartaglia, Maria Carmela, additional, Ruttan, Lesley, additional, Choi, May Y., additional, Appenzeller, Simone, additional, Marzouk, Sherief, additional, Bonilla, Dennisse, additional, Katz, Patricia, additional, Beaton, Dorcas, additional, Green, Robin, additional, Gladman, Dafna D., additional, Wither, Joan, additional, and Touma, Zahi, additional
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- 2024
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13. Validity and score interpretation of the 12-item Psoriatic Arthritis Impact of Disease: an analysis of pooled data from two phase 3 trials of bimekizumab in patients with psoriatic arthritis
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Gossec, Laure, primary, Orbai, Ana-Maria, additional, Coates, Laura C, additional, Gladman, Dafna D, additional, Ogdie, Alexis, additional, Pelligra, Christopher G, additional, Ciaravino, Valérie, additional, Ink, Barbara, additional, Taieb, Vanessa, additional, Lambert, Jérémy, additional, and de Wit, Maarten, additional
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- 2024
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14. Circulating neutrophil extracellular trap remnants as a biomarker to predict outcomes in lupus nephritis
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Whittall-Garcia, Laura Patricia, primary, Naderinabi, Farnoosh, additional, Gladman, Dafna D, additional, Urowitz, Murray, additional, Touma, Zahi, additional, Konvalinka, Ana, additional, and Wither, Joan, additional
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- 2024
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15. Residual Disease Activity in Canadian Patients With Psoriatic Arthritis Treated With Advanced Therapies: Results From a Multiregistry Analysis (UNISON-PsA).
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Gladman, Dafna D., Chandran, Vinod, Rosen, Cheryl F., Rohekar, Sherry, Boyd, Tristan, Eder, Lihi, Rahman, Proton, Dutz, Jan, Chan, Jonathan, Haydey, Richard P., Barac, Snezana, Laliberté, Marie-Claude, Girard, Tanya, Fournier, Pierre-André, Sutton, Mitchell, Pereira, Daniel, Chim, Tina, Coupal, Louis, and Choquette, Denis
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- 2024
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16. Different Immunologic Profiles Are Associated With Distinct Clinical Phenotypes in Longitudinally Observed Patients With Systemic Lupus Erythematosus.
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Manion, Kieran, Muñoz‐Grajales, Carolina, Kim, Michael, Atenafu, Eshetu, Faheem, Zoha, Gladman, Dafna D., Urowitz, Murray, Touma, Zahi, and Wither, Joan E.
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SYSTEMIC lupus erythematosus treatment ,FLOW cytometry ,PARAMETERS (Statistics) ,SYSTEMIC lupus erythematosus ,DECISION making in clinical medicine ,LONGITUDINAL method ,MATHEMATICAL statistics ,T helper cells ,PHENOTYPES ,NONPARAMETRIC statistics ,B cells ,SYMPTOMS - Abstract
Objective: The aim of this study was to determine the immunologic profile associated with disease flares in patients with systemic lupus erythematosus (SLE) and to investigate the clinical significance of any differences observed between patients during and following a flare. Methods: Multiparameter flow cytometry was used to examine 47 immune populations within the peripheral blood of 16 healthy controls, 25 patients with clinically quiescent SLE, and 46 patients with SLE experiencing a flare at baseline and at 6‐ and 12‐month follow‐up visits. Unsupervised clustering was used to identify patients with similar immune profiles and to track changes over time. Parametric or nonparametric statistics were used when appropriate to assess the association of cellular phenotypes with clinical and laboratory parameters. Results: Five clusters of patients were identified that variably contained patients with active and quiescent SLE, and that had distinct clinical phenotypes. Patients characterized by increased T peripheral helper, activated B, and age‐associated B cells were the most likely to be flaring at baseline, as well as the most likely to remain active or flare over the subsequent year if they acquired or retained this phenotype at follow‐up. In contrast, patients who had increased T helper (Th) cells in the absence of B cell changes, or who had increased Th1 cells and innate immune populations, mostly developed quiescent SLE on follow‐up. A significant proportion of patients with SLE had depletion of many immune populations at flare and only showed increases in these populations post‐flare. Conclusion: Cellular phenotyping of patients with SLE reveals several distinct immunologic profiles that may help to stratify patients with regard to prognosis and treatment. [ABSTRACT FROM AUTHOR]
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- 2024
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17. Derivation and Internal Validation of a Disease-Specific Cardiovascular Risk Prediction Model for Patients With Psoriatic Arthritis and Psoriasis.
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Colaco, Keith, Ker-Ai Lee, Akhtari, Shadi, Winer, Raz, Chandran, Vinod, Harvey, Paula, Cook, Richard J., Piguet, Vincent, Gladman, Dafna D., and Eder, Lihi
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MYOCARDIAL infarction risk factors ,CARDIOVASCULAR disease prevention ,HEART failure risk factors ,CARDIOVASCULAR disease related mortality ,CARDIOVASCULAR diseases risk factors ,PSORIATIC arthritis ,PSORIASIS ,CONFIDENCE intervals ,RESEARCH methodology ,MAJOR adverse cardiovascular events ,MULTIPLE regression analysis ,NONSTEROIDAL anti-inflammatory agents ,REGRESSION analysis ,ACQUISITION of data ,ANGINA pectoris ,RISK assessment ,SEVERITY of illness index ,ANTIRHEUMATIC agents ,THEORY ,RESEARCH funding ,DESCRIPTIVE statistics ,QUESTIONNAIRES ,MEDICAL records ,MYOCARDIAL revascularization ,BLOOD sedimentation ,HEALTH behavior ,PREDICTION models ,SENSITIVITY & specificity (Statistics) ,RECEIVER operating characteristic curves ,DATA analysis software ,LONGITUDINAL method ,BEHAVIOR modification ,DISEASE risk factors ,DISEASE complications - Abstract
Objective. To address suboptimal cardiovascular risk prediction in patients with psoriatic disease (PsD), we developed and internally validated a five-year disease-specific cardiovascular risk prediction model. Methods. We analyzed data from a prospective cohort of participants with PsD without a history of cardiovascular events. Traditional cardiovascular risk factors and PsD-related measures of disease activity were considered as potential predictors. The study outcome included nonfatal and fatal cardiovascular events. A base prediction model included 10 traditional cardiovascular risk factors. Eight PsD-related factors were assessed by adding them to the base model to create expanded models, which were controlled for PsD therapies. Variable selection was performed using Least Absolute Shrinkage and Selection Operator (LASSO) penalized regression with 10-fold cross-validation. Model performance was assessed using measures of discrimination and calibration and measures of sensitivity and specificity. Results. Between 1992 and 2020, 85 of 1,336 participants developed cardiovascular events. Discrimination of the base model (with traditional cardiovascular risk factors alone) was excellent, with an area under the receiver operator characteristic curve (AUC) of 85.5 (95% confidence interval [CI] 81.9–89.1). Optimal models did not select any of the tested disease-specific factors. In a sensitivity analysis, which excluded lipid lowering and antihypertensive treatments, the number of damaged joints was selected in the expanded model. However, this model did not improve risk discrimination compared to the base model (AUC 85.5, 95% CI 82.0–89.1). Conclusion. Traditional cardiovascular risk factors alone are effective in predicting cardiovascular risk in patients with PsD. A risk score based on these factors performed well, indicating excellent discrimination and calibration. [ABSTRACT FROM AUTHOR]
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- 2024
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18. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update.
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Fanouriakis, Antonis, Kostopoulou, Myrto, Andersen, Jeanette, Aringer, Martin, Arnaud, Laurent, Bae, Sang- Cheol, Boletis, John, Bruce, Ian N., Cervera, Ricard, Dörner, Andrea Doria Thomas, Furie, Richard A., Gladman, Dafna D., Houssiau, Frederic A., Inês, Luís Sousa, Jayne, David, Kouloumas, Marios, Kovács, László, Mok, Chi Chiu, Morand, Eric F., and Moroni, Gabriella
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- 2024
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19. Circulating neutrophil extracellular trap remnants as a biomarker to predict outcomes in lupus nephritis.
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Patricia Whittall-Garcia, Laura, Naderinabi, Farnoosh, Gladman, Dafna D., Urowitz, Murray, Touma, Zahi, Konvalinka, Ana, and Wither, Joan
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- 2024
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20. Increased risk of severe generalized pustular psoriasis due to tuberculosis screening delay for spesolimab initiation
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Gladman, Dafna D., Reddy, Soumya, Merola, Joseph, Calabrese, Cassandra, Lebwohl, Mark, Kindred, Chesahna, Miller, Lauren, Kircik, Leon, Liu, Clive, Lewitt, G. Michael, Lee, Lara Wine, Desai, Seemal, Van Voorhees, Abby, Glick, Brad P., Soung, Jennifer, Hackley, Madison, Thampy, Daphne, Waseh, Shayan, Feldman, Steven R., Blauvelt, Andrew, Weinberg, Jeffrey M., Schwartzman, Sergio, Liao, Wilson, Prussick, Ronald, Cohen, Jeffrey M., and Hsu, Sylvia
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- 2024
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21. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial.
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Gossec L, Coates LC, Gladman DD, Aelion JA, Vasandani J, Pinter A, Merola JF, Kavanaugh A, Reddy J, Wang R, Brunori M, Klyachkin Y, Deignan C, and Mease PJ
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Objectives: Oligoarticular psoriatic arthritis (PsA) is frequent but rarely studied. The objective was to assess the efficacy of apremilast in early oligoarticular PsA., Methods: FOREMOST (NCT03747939) was a phase 4 multicentre, randomised, double-blind, placebo-controlled trial. Patients had early (symptom duration ≤5 years) oligoarticular PsA (>1 but ≤4 swollen and >1 but ≤4 tender joints; 2-8 total active joints). Patients were randomised 2:1 to apremilast 30 mg two times per day or placebo for 24 weeks, with an early escape at week 16. The primary endpoint was the proportion of patients at week 16 who achieved minimal disease activity (MDA)-Joints (modification of MDA mandating ≤1 swollen joint and ≤1 tender joint) based on sentinel joints (those affected at baseline) with a combination of non-responder imputation and multiple imputations. Exploratory analysis assessed all joints., Results: Of 308 patients randomised (apremilast: n=203; placebo: n=105), mean (SD) PsA duration was 9.9 (10.2) months, mean (SD) age was 50.9 (12.5) years and 39.9% of patients were using a conventional synthetic disease-modifying antirheumatic drug. MDA-Joints (sentinel joints (primary endpoint) and all joints) were achieved by significantly more patients with apremilast (33.9% and 21.3%) vs placebo (16.0% and 7.9%) at week 16 (p=0.0008 and nominal p=0.0028, respectively). Greater improvements in patient-reported outcomes, clinical disease activity and skin involvement were also seen with apremilast versus placebo., Conclusions: FOREMOST is the first randomised controlled trial designed for early oligoarticular PsA and showed apremilast improves clinical and patient-reported outcomes. This trial may inform the optimal management of PsA in these patients., Trial Registration Number: NCT03747939., Competing Interests: Competing interests: LG has received medical writing support and honoraria as part of advisory boards for this study. Outside this work: grants or contracts from AbbVie, Biogen, Lilly, Novartis and UCB; consulting fees from AbbVie, BMS, Celltrion, Janssen, Novartis, Pfizer and UCB; honoraria for lectures from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer and UCB; support for attending meetings and/or travel from MSD, Novartis and Pfizer; and medical writing support from AbbVie, Janssen, Galapagos, and UCB. LCC: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB–grant/research support, consulting fees, and/or speaker honoraria. LCC was supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre (BRC). DDG: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB–grant/research support or consulting fees. JAA: AbbVie, Amgen–speakers bureau; AbbVie, Ardea Biosciences, AstraZeneca, Bristol Myers Squibb, Celgene, Centocor, Eli Lilly, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Takeda, UCB, Vertex–grant/research support. JV: Nothing to disclose. AP: AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, GSK, Eli Lilly, Galderma, Hexal, Janssen, LEO-Pharma, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Schering-Plough, UCB Pharma–investigator/speaker/advisor. JFM: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, EMD, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Serono, Sun, UCB–consultant and/or investigator. AK: Amgen, AbbVie, BMS, Janssen, Novartis, Pfizer, Eli Lilly–grant/research support and consultant. JR, RW, MB, YK and CD: Employment by and stock ownership in Amgen. PJM: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB–grant/research support and consultant; Boehringer Ingelheim, GlaxoSmithKline–consultant; AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB–speakers bureau., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
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- 2024
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22. Short and Long-Term Outcomes of Patients with Pure Membranous Lupus Nephritis Compared to Patients with Proliferative Disease.
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Kharouf F, Li Q, Whittall Garcia LP, Jauhal A, Gladman DD, and Touma Z
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Objectives: Membranous lupus nephritis (MLN) is thought to have a more benign course than proliferative lupus nephritis (PLN). We aimed to determine the differences in short and long-term outcomes between patients with MLN and PLN., Methods: We included patients with first biopsy-proven MLN and PLN. Short-term outcomes included complete proteinuria recovery (CPR), complete renal response (CRR), and primary efficacy renal response (PERR). Long-term outcomes included a sustained ≥40% reduction in baseline estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular (CV) events, ≥2 increase in SDI, and death. Univariable and multivariable Cox proportional hazard models were used to examine the effect of baseline characteristics on long-term outcomes., Results: Of 215 patients, 51 had pure MLN, and 164 had PLN. We found no significant differences between the two groups in achieving CPR, CRR, and PERR at 1 and 2 years. Median time to outcomes was slightly, but insignificantly, longer in the MLN group.For long-term outcomes, PLN was associated with worse renal and non-renal outcomes, but this was not statistically significant.In the multivariable Cox proportional hazard models, ESKD was associated with the following baseline variables: younger age (HR 0.92, 95% CI 0.87-0.97), higher creatinine (HR 1.01, 95% CI 1.01-1.02), low complement (HR 4.0, 95% CI 1.04-11.10), and higher chronicity index (HR 1.28, 95% CI 1.08-1.51)., Conclusion: The resolution of proteinuria in LN is slow. MLN is not a benign disease and may be associated with deterioration of renal function, ESKD, damage, CV events, and death., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2024
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23. Canadian Rheumatology Association/Spondyloarthritis Research Consortium of Canada Living Treatment Recommendations for the Management of Axial Spondyloarthritis.
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Rohekar S, Pardo Pardo J, Mirza R, Aydin SZ, Bessette L, Richard N, Mosher D, Boyd T, Chan J, Eder L, Passalent L, Karam E, Nair B, Hazlewood GS, Tse S, Rumsey D, Zummer M, Haroon N, Inman R, and Gladman DD
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Objective: To provide a set of living treatment recommendations that will give contemporary guidance on the management of patients with axial spondyloarthritis (axSpA) in Canada., Methods: The Spondyloarthritis Research Consortium of Canada (SPARCC), in conjunction with the Canadian Rheumatology Association, organized a treatment recommendations panel composed of rheumatologists, researchers, allied health professionals, and a patient advocate. A Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach was used, in which existing guidelines were adopted or adapted to a Canadian context. Recommendations were also placed in a health equity framework., Results: Fifty-six recommendations were made for patients with active axSpA, stable axSpA, active or stable axSpA, for comorbidities, and for assessment, screening, and imaging. Recommendations were also made for principles of management, disease monitoring, and ethical considerations., Conclusion: These living treatment recommendations will provide up-to-date guidance for the management of axSpA for Canadian practice. As part of the living model, they will be updated regularly as changes occur in the treatment landscape.
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- 2024
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24. Treatment controversies in spondyloarthritis and psoriatic arthritis: focus on biologics and targeted therapies.
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Kharouf F and Gladman DD
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Introduction: There are several treatment controversies that have emerged in spondyloarthritis and psoriatic arthritis. These are related to the nature of the conditions as well as to the use of medications., Areas Covered: This review, which included a search of PubMed database as well as the references within the articles provides an overview of the nature of spondyloarthritis, controversy over the inclusion of psoriatic arthritis (PsA) as a peripheral spondyloarthritis, and a summary of current treatments for both PsA and axial spondyloarthritis (axSpA), with special emphasis on targeted therapy. The review highlights the differences in response to certain medications, particularly biologic therapy and summarizes the randomized controlled trials in psoriatic arthritis and axial spondyloarthritis providing data about the responses in table format., Expert Opinion: There is a need for better outcome measures in axSpA. Currently, the measures are subjective. Imaging may be more appropriate but there is a need for research into the reliability and responsiveness of imaging techniques. In PsA, there may also be better response measures and research into the reliability and responsiveness of available measures is underway. There is also a need for novel therapies as well as biomarkers for response in both diseases.
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- 2024
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25. OMERACT systemic lupus erythematosus domain survey.
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Nielsen W, Strand V, Simon L, Pinsker E, Bonilla D, Morand E, Thumboo J, Aringer M, Mosca M, Bruce I, Parodis I, Kim A, Desai M, Enman Y, Shea B, Wallace DJ, Chaichian Y, Navarra S, Aranow C, Mackay M, Trotter K, Tayer-Shifman OE, Duarte-García A, Shan Tam L, Ugarte-Gil MF, Pons-Estel GJ, Reynolds JA, Nikpour M, Hoi A, Romero-Diaz J, Aggarwal A, Mok CC, Fujio K, Ramsey-Goldman R, Gladman DD, Arnaud L, Bultink IEM, Ruiz-Irastorza G, Inês LS, Appenzeller S, Dobrowolski C, Clarke AE, Kamen DL, Barraclough M, Tani C, Gómez-Puerta JA, Werth VP, Katz P, Nowrouzi-Kia B, Johnson SR, Drucker AM, and Touma Z
- Abstract
Background: Since the development of the OMERACT Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) in 1998, many new SLE domains have been identified and measures developed, creating a need to update the SLE COS. To revisit the 1998 SLE COS and research agenda domains, and generate new candidate domains, we conducted this study of patients with SLE and collaborators., Objective: (1) To evaluate existing candidate SLE domains for inclusion in the SLE COS. (2) To generate additional candidate SLE domains for COS consideration. (3) To engage SLE collaborators, including patients, in developing the updated SLE COS., Methods: The OMERACT SLE Working Group's steering committee developed a survey to assess the importance of candidate SLE domains and generate additional domains for consideration towards the SLE COS. Patients with SLE followed at the University of Toronto Lupus Clinic (patient group) and members of the OMERACT SLE Working Group (collaborator group) were invited to complete the survey between August 2022 and February 2023., Results: A total of 175 patients were invited and 100 completed the survey. Of 178 collaborators invited, 145 completed the survey. Patients tended to prioritize life-impact domains while collaborators prioritized clinical domains. Both patients and collaborators recommended additional domains to those included in the 1998 SLE COS and research agenda., Conclusion: The domain inclusion and importance results demonstrate that patients and collaborators prioritize different domains, so capturing the perspectives of both groups is essential to ensure a holistic assessment of SLE. The results of the study identify domains that already have a high level of agreement for potential inclusion in the SLE COS, domains that require further explanation, and novel domains that warrant consideration., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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26. Composite Outcome Measures for Psoriatic Arthritis: OMERACT and 3 and 4 Visual Analog Scale Progress in 2023.
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Leung YY, Gladman DD, Orbai AM, and Tillett W
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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group provided updates at the GRAPPA 2023 annual meeting on its work to evaluate composite outcome measures for PsA. An ongoing systematic literature review is in progress to evaluate psychometric measurement properties using the OMERACT filter 2.2 for a list of candidate composite outcome measures, which include minimal disease activity (MDA), Disease Activity for Psoriatic Arthritis (DAPSA), American College of Rheumatology (ACR) response criteria, Psoriatic Arthritis Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), 3 visual analog scale (3VAS), and 4VAS. The performance of the 3VAS and 4VAS in clinical practice and a synthesis of new data were presented, including estimates for minimal clinically important differences and thresholds of meaning, discrimination and construct validity, and longitudinal construct validity. Numeric rating scale (NRS) versions of the VAS have also been tested. Performance characteristics and psychometric properties are similar to the ASSESS study, a UK multicenter study, indicating that the VAS scales may be feasible tools for routine clinical care with a preference for the 4VAS because of superior face validity and clinical utility.
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- 2024
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27. Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 Annual Meeting.
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Gladman DD, FitzGerald O, Armstrong AW, Goel N, and Gottlieb AB
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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting was held on July 13 to 15, 2023, in Dublin, Ireland, and was attended by 285 rheumatologists, dermatologists, trainees, patient research partners (PRPs), representatives of patient organizations, and industry partners. The 20th anniversary of GRAPPA was celebrated with a special presentation and archival video. Ahead of the meeting, the PRP Network met, a workshop was held by the International Dermatology Outcome Measures (IDEOM) group, and there was a workshop in which researchers discussed advancing ultrasound use to improve the management of psoriatic disease (PsD). Young-GRAPPA also held a workshop and business meeting. Multiple presentations highlighted important topics currently influencing PsD, including ensuring that patients are included in advancing research, the role of depression in PsD, the use of magnetic resonance imaging for spinal lesions, and animal models of PsD, among others. Debates focused on whether biologics should be used for mild psoriasis, whether methotrexate should remain the first-line treatment for PsD, and whether PsD is really a primary enthesitis driving joint synovitis. Here we provide an overview of the features of the GRAPPA 2023 annual meeting and introduce the manuscripts published together in this supplement as a meeting report.
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- 2024
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28. GRAPPA 2023: Major Projects, Key Advances, and Milestones.
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Ayan G, Aydin SZ, Coates LC, Eder L, Gladman DD, Helliwell PS, Kaeley GS, Kavanaugh A, Mease PJ, Pennington SR, Proft F, Soriano ER, and FitzGerald O
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At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting, members were updated on a number of ongoing activities during the key project update session. These activities included the Axial Involvement in Psoriatic Arthritis (AXIS) cohort, the Axial Psoriatic Arthritis Molecular and Clinical Characterization study, the Diagnostic Ultrasound Enthesitis Tool (DUET) study, the Sex- and Gender-Based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) study, the Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States (HIPPOCRATES), the GRAPPA slide library, and the GRAPPA treatment recommendations.
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- 2024
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29. GRAPPA 2023 Collaborative Research Network Meeting.
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Chandran V, Gladman DD, Mease PJ, Eder L, Pennington SR, FitzGerald O, Ritchlin C, Webster DE, de Vlam K, and Liao W
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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Collaborative Research Network (CRN)/research committee met during the GRAPPA 2023 annual meeting. Updates were provided on GRAPPA research projects, including the Axial Involvement in Psoriatic Arthritis (AXIS), Axial Psoriatic Arthritis Molecular and Clinical Characterisation Study, Diagnostic Ultrasound Enthesitis Tool (DUET), and Sex- and Gender-Based Analysis of the Effectiveness of Advanced Therapies (SAGE) studies, as well as the Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States (HIPPOCRATES) and Elucidating the Landscape of Immunoendotypes in Psoriatic Skin and Synovium (ELLIPSS) studies. The highlight of the meeting was a presentation and discussion on the use of digital tools to study psoriatic disease.
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- 2024
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30. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Celebrates Its 20th Anniversary.
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Gladman DD, Helliwell PS, and Mease PJ
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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) started in August 2003 with 40 initial participants and celebrated its 20th anniversary with 1036 members, many of whom attended the annual meeting in Dublin, Ireland, on July 15 to 17, 2023. GRAPPA arose from a need experienced by psoriatic arthritis (PsA) and psoriasis (PsO) investigators to meet to address questions related to psoriatic disease (PsD). Though other groups were meeting at the time to classify and discuss PsA, GRAPPA arose from a desire to include international clinical and investigational researchers of both dermatology and rheumatology. The organization has built awareness of PsO and PsA, developed and validated research assessment tools to measure clinical status and disease outcomes, published multiple treatment recommendations, supported basic and clinical research on PsD pathophysiology, fostered interactions across research fields, and educated the future generation of PsO and PsA researchers. The group continues to focus on major priorities affecting patients with PsD and will continue evolving in the next decades.
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- 2024
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31. Effect of Bimekizumab on Patient-Reported Disease Impact in Patients with Psoriatic Arthritis: 1-Year Results from Two Phase 3 Studies.
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Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, and Gladman DD
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Objectives: To evaluate 1-year bimekizumab efficacy in psoriatic arthritis (PsA) from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire., Methods: BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to week 40 in BE COMPLETE)., Results: Overall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at week 4 continued to week 16 and were sustained to 1 year. At 1 year, mean (standard error) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at week 16 (bDMARD-naïve bimekizumab -2.3 [0.1], placebo/bimekizumab -2.2 [0.1]; TNFi-IR bimekizumab -2.5 [0.1], placebo/bimekizumab -2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems., Conclusion: Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2024
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32. Remission and low disease activity are associated with lower healthcare costs: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort.
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Barber MRW, Ugarte-Gil MF, Hanly JG, Urowitz MB, St-Pierre Y, Gordon C, Bae SC, Romero-Diaz J, Sanchez-Guerrero J, Bernatsky S, Wallace DJ, Isenberg DA, Rahman A, Merrill JT, Fortin PR, Gladman DD, Bruce IN, Petri M, Ginzler EM, Dooley MA, Ramsey-Goldman R, Manzi S, Jönsen A, van Vollenhoven RF, Aranow C, Mackay M, Ruiz-Irastorza G, Lim SS, Inanc M, Kalunian KC, Jacobsen S, Peschken CA, Kamen DL, Askanase A, Pons-Estel BA, Cardwell FS, Alarcón GS, and Clarke AE
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Objectives: This study aims to determine the independent impact of definitions of remission/low disease activity (LDA) on direct/indirect costs (DCs, ICs) in a multicentre inception cohort., Methods: Patients from 31 centres in 10 countries were enrolled within 15 months of diagnosis and assessed annually. Five mutually exclusive disease activity states (DAS) were defined as (1) remission off-treatment: clinical (c) SLEDAI-2K=0, without prednisone/immunosuppressants; (2) remission on-treatment: cSLEDAI-2K=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; (3) LDA-Toronto Cohort (TC): cSLEDAI-2K≤2, without prednisone/immunosuppressants; (4) modified lupus LDA state (mLLDAS): SLEDAI-2K≤4, no activity in major organs/systems, no new activity, prednisone ≤7.5 mg/day and/or maintenance immunosuppressants and (5) active: all remaining assessments.At each assessment, patients were stratified into the most stringent DAS fulfilled and the proportion of time in a DAS since cohort entry was determined. Annual DCs/ICs (2021 Canadian dollars) were based on healthcare use and lost workforce/non-workforce productivity over the preceding year.The association between the proportion of time in a DAS and annual DC/IC was examined through multivariable random-effects linear regressions., Results: 1692 patients were followed a mean of 9.7 years; 49.0% of assessments were active. Remission/LDA (per 25% increase in time in a remission/LDA state vs active) were associated with lower annual DC/IC: remission off-treatment (DC -$C1372; IC -$C2507), remission on-treatment (DC -$C973; IC -$C2604,) LDA-TC (DC -$C1158) and mLLDAS (DC -$C1040). There were no cost differences between remission/LDA states., Conclusions: Our data suggest that systemic lupus erythematosus patients who achieve remission, both off and on-therapy, and reductions in disease activity incur lower costs than those experiencing persistent disease activity., Competing Interests: Competing interests: MRWB has received consulting fees, speaking fees and/or honoraria from AbbVie, AstraZeneca, GlaxoSmithKline, Janssen and Sanofi Genzyme. MFU-G has received consulting and/or speaking fees from AstraZeneca, GlaxoSmithKline, Ferrer and a research grant from Janssen. CG has received consulting fees, speaking fees, and/or honoraria from AstraZeneca, Abbvie, Amgen, Sanofi, and UCB (less than $10 000 each). DJW has received consulting fees from Merck, EMD Serono, Pfizer, Lilly and Glenmark (less than $10 000 each). PRF has received consulting fees from AstraZeneca and GlaxoSmithKline (less than $10 000 each). DDG received consulting fees and/or honoraria from GlaxoSmithKline and AstraZeneca (less than $10 000). INB has received consulting fees, speaking fees, and/or honoraria from Eli Lilly, UCB, Roche, Merck Serono, MedImmune (less than $10 000 each) and grants from UCB, Genzyme Sanofi, and GlaxoSmithKline. EMG has paid consultation with investment analysts Guidepoint Global Gerson Lerman Group. RR-G has received consulting fees from Cabaletta, BristolMyersSquibb, Biogen, Merck, and Ampel Solutions (all less than $10 000 each). RFvV has received consulting fees, speaking fees and/or honoraria from AbbVie, AstraZeneca, Biotest, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, and UCB (less than $10 000 each) and research support from AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Pfizer and UCB. MI has received consulting fees from UCB and Amgen (less than $10 000 each). KK has received grants from UCB, Human Genome Sciences/GlaxoSmithKline, Takeda, Ablynx, Bristol-Myers Squibb, Pfizer, and Kyowa Hakko Kirin, and has received consulting fees from Exagen Diagnostics, Genentech, Eli Lilly, Bristol-Myers Squibb and Anthera (less than $10 000 each). AEC has received consulting fees, speaking fees, and/or honoraria from AstraZeneca, BristolMyersSquibb, GlaxoSmithKline, Roche and Otsuka (less than $10 000 each) and a research grant from GlaxoSmithKline. No other disclosures relevant to this article were reported., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
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33. Patient clusters identified by machine learning from a pooled analysis of the clinical development programme of secukinumab in psoriatic arthritis, ankylosing spondylitis and psoriatic arthritis with axial manifestations.
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Baraliakos X, Pournara E, Coates LC, Mease PJ, Jahandideh SS, and Gladman DD
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- Humans, Male, Middle Aged, Adult, Female, Overweight, Antibodies, Monoclonal, Humanized therapeutic use, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic drug therapy, Spondylitis, Ankylosing diagnosis, Spondylitis, Ankylosing drug therapy
- Abstract
Objectives: To identify patient clusters based on baseline demographics and clinical indicators., Methods: Pooled baseline demographics and clinical data of secukinumab-treated patients from ten Phase III studies in psoriatic arthritis (PsA; FUTURE 1-5 and MAXIMISE), ankylosing spondylitis (AS; MEASURE 1-4), were analysed by machine learning (ML) algorithms. The longitudinal responses of secukinumab 300 mg versus 150 mg were investigated across the clusters and three clinical indicators of tender joints, swollen joints and enthesitis., Results: 3907 patients were grouped into eight distinct clusters based on patient demographics and baseline clinical characteristics. Patients with PsA and axial manifestations (MAXIMISE) were overrepresented in clusters 6-8. Patients in cluster 6 (mean age 48 years; 46% male) were overweight with pronounced psoriasis, higher articular burden in knees, shoulders, elbows and wrists. Patients in cluster 7 (mean age 47 years; 53% male) were less overweight with lower polyarticular joint counts and tenderness of the joints of the feet, wrists and hands. Patients in cluster 8 were predominantly with AS (mean age 43 years; 64% male) with a mean body mass index of 27.3 kg/m2, oligoarthritis and high prevalence of spinal pain. Patients with PsA (FUTURE) were overrepresented in clusters 1-5. Longitudinal analysis showed improvements with secukinumab 300 mg versus 150 mg in clusters 6 and 8 for tender joint counts, and cluster 7 for swollen joint counts., Conclusions: PsA clusters obtained by ML in pooled dataset indicate phenotypical heterogeneity of patients with PsA and axial manifestations and overlapping features across the spondyloarthritis spectrum.
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- 2024
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