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3. POS0248 THE EVALUATION OF A NOVEL TRAINING INFOGRAPHIC FOR THE PHYSICIAN VISUAL ANALOGUE SCALE (VAS) IN PSORIATIC ARTHRITIS

Author

Gunawardana, S., primary, Helliwell, P. S., additional, Kok, M. R., additional, Vis, M., additional, Allard, A., additional, Akpabio, A., additional, Alsaffar, A., additional, Ellis, J., additional, Kasiem, F. R., additional, Macmillan, R., additional, Mulhearn, B., additional, Gorman, A., additional, Coates, L. C., additional, and Tillett, W., additional

Published
2024
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4. PCR229 Achieving Increasingly Stringent Disease Control Criteria Was Associated with Greater Quality of Life Improvements in Patients with Active Psoriatic Arthritis: Results from BE OPTIMAL and BE COMPLETE/BE VITAL up to 1 Year

Author

Kristensen, L.E., primary, Coates, L.C., additional, Mease, P.J., additional, Merola, J.F., additional, Gisondi, P., additional, Nash, P., additional, Ogdie, A.R., additional, Tillett, W., additional, Ink, B., additional, Bajracharya, R., additional, Taieb, V., additional, Lambert, J., additional, Willems, D., additional, and Walsh, J.A., additional

Published
2023
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5. Étude observationnelle prospective de 24 mois de la persistance du traitement chez des patients atteints de rhumatisme psoriasique (PRO-SPIRIT) – conception de l’étude et caractéristiques des patients à l’inclusion (échantillon complet)

Author

Morel, J., primary, Lubrano, E., additional, Tillett, W., additional, Alten, R., additional, Kristensen, L.E., additional, Chandran, V., additional, Treuer, T., additional, Burke, J., additional, Ferrer, A. Martinez, additional, Holzkämper, T., additional, and Gullick, N., additional

Published
2023
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6. Maintien de l’efficacité du bimékizumab pendant 52 semaines chez les patients atteints de rhumatisme psoriasique, naïfs de biologique et répondeurs à la semaine 16 : résultats de BE OPTIMAL, étude de phase III avec un bras de référence actif

Author

Gossec, L., primary, Tillett, W., additional, Merola, J.F., additional, Tanaka, Y., additional, Favalli, E.G., additional, McGonagle, D., additional, Walsh, J.A., additional, Thaçi, D., additional, Ink, B., additional, Bajracharya, R., additional, Taieb, V., additional, and Ritchlin, C.T., additional

Published
2023
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9. POS0077-HPR ENHANCING CURRENT GUIDANCE FOR PSORIATIC ARTHRITIS AND ITS COMORBIDITIES: RECOMMENDATIONS FROM AN EXPERT CONSENSUS PANEL OF HEALTHCARE PROFESSIONALS IN THE UK

Author

Coates, L., primary, Bukhari, M., additional, Chan, A., additional, Choy, E., additional, Galloway, J., additional, Gullick, N., additional, Kent, A., additional, Savage, L., additional, Siebert, S., additional, Tillett, W., additional, Wood, N., additional, and Conaghan, P. G., additional

Published
2023
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10. POS0224 ENHANCED SURVEILLANCE FOR THE DETECTION OF PSORIATIC ARTHRITIS IN A UK PRIMARY CARE PSORIASIS POPULATION VERSUS USUAL CARE: RESULTS AT 24 MONTHS FROM THE THE TOTAL BURDEN OF PSORIASIS (TUDOR) RANDOMISED CONTROL TRIAL

Author

Brown, S., primary, Coates, L., additional, Collier, H., additional, Davies, C., additional, Helliwell, P., additional, Packham, J., additional, Ransom, M., additional, Tillett, W., additional, and Mchugh, N., additional

Published
2023
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11. AB1100 ACHIEVEMENT OF INCREASINGLY STRINGENT CLINICAL DISEASE CONTROL CRITERIA WAS ASSOCIATED WITH GREATER IMPROVEMENTS IN PHYSICAL FUNCTION, PAIN AND FATIGUE IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: 52-WEEK RESULTS FROM BE OPTIMAL, A PHASE 3 RANDOMISED, PLACEBO-CONTROLLED STUDY

Author

Kristensen, L. E., primary, Coates, L., additional, Mease, P. J., additional, Merola, J. F., additional, Gisondi, P., additional, Nash, P., additional, Orbai, A. M., additional, Tillett, W., additional, Ink, B., additional, Bajracharya, R., additional, Taieb, V., additional, Lambert, J., additional, Willems, D., additional, and Walsh, J. A., additional

Published
2023
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15. POS0228 MINIMAL IMPORTANT DIFFERENCE (MID), MINIMAL DETECTABLE CHANGE (MDC), AND DISEASE ACTIVITY THRESHOLDS FOR TWO NOVEL COMPOSITE INSTRUMENTS (3VAS, 4VAS) IN PATIENTS WITH PSORIATIC ARTHRITIS: POOLED ANALYSIS OF THREE PHASE 3 STUDIES

Author

Tillett, W., primary, Coates, L., additional, Vis, M., additional, Merola, J. F., additional, Soriano, E., additional, Perate, M., additional, Shawi, M., additional, Zimmermann, M., additional, Rampakakis, E., additional, Sharaf, M., additional, Nash, P., additional, and Helliwell, P., additional

Published
2023
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18. AB1115 STUDY DESIGN AND FULL BASELINE SAMPLE CHARACTERISTICS OF PATIENTS FROM THE 24-MONTH MULTINATIONAL PROSPECTIVE PSORIATIC ARTHRITIS OBSERVATIONAL STUDY OF PERSISTENCE OF TREATMENT (PRO-SPIRIT)

Author

Morel, J., primary, Lubrano, E., additional, Tillett, W., additional, Alten, R., additional, Kristensen, L. E., additional, Chandran, V., additional, Treuer, T., additional, Burke, J., additional, Martínez-Ferrer, À., additional, Holzkaemper, T., additional, and Gullick, N., additional

Published
2023
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21. Executive Retreat: proceedings of the GRAPPA Executive Retreat 2022

Author

Ng, B, Jadon, D, Adebajo, A, Ayan, G, Callis Duffin, K, Chandran, V, Coates, LC, D’Agostino, MA, de Vlam, K, Deodhar, A, Eder, L, Garg, A, Gladman, DD, Goel, N, Gottlieb, A, Husni, ME, Katz, A, Kavanaugh, A, Lubrano, E, Mease, P, Merola, J, Nash, P, Ogdie, A, Pennington, S, Perez-Chada, LM, Proft, F, Rosen, CF, Savage, L, Goldenstein-Schainberg, C, Siebert, S, Soriano, E, Steinkoenig, I, Tillett, W, Armstrong, A, and FitzGerald, O

Published
2023

23. The state of the art—psoriatic arthritis outcome assessment in clinical trials and daily practice

Author

Day, J, Antony, A, Tillett, W, and Coates, LC

Subjects
Rheumatology, Immunology, Immunology and Allergy
Abstract

Psoriatic arthritis is a heterogeneous condition with substantial challenges in optimising outcome measures for both clinical trials and daily practice. As with other inflammatory arthritides, there is no gold standard instrument for measuring disease activity or impact, both of which are key to evaluate therapeutic approaches in trials and monitor disease in daily practice. A wide range of domains have been highlighted in the Outcome Measures in Rheumatology (OMERACT) core domain set for psoriatic arthritis; reflecting the disease involvement in multiple tissues (joints, tendons, skin, and spine) and the heterogenous impact of the disease on individuals. This Review summarises the current evidence around outcome measure selection, considering factors such as unidimensional versus multidimensional outcomes, continuous versus binary measures, and the feasibility of these approaches in trials compared with clinical practice.

Published
2022
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24. Executive summary: The 2022 British Society for Rheumatology guideline for the treatment of psoriatic arthritis with biologic and targeted synthetic DMARDs

Author

Tucker, L, Allen, A, Chandler, D, Ciurtin, C, Dick, A, Foulkes, A, Gullick, N, Helliwell, P, Jadon, D, Jones, G, Kyle, S, Madhok, V, McHugh, N, Parkinson, A, Raine, T, Siebert, S, Smith, C, Tillett, W, and Coates, LC

Subjects
dactylitis, treatment, enthesitis, psoriasis, targeted synthetic DMARDs, PsA, Rheumatology, recommendations, biologics, Pharmacology (medical), guideline, management
Published
2022
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25. PCR117 Achieving Stringent Clinical Disease Control Criteria Is Associated With Improved Quality of Life Measures in Patients With Active Psoriatic Arthritis: Results From Two Phase 3 Randomised, Placebo-Controlled Studies

Author

Kristensen, LE, primary, Coates, LC, additional, Mease, PJ, additional, Nash, P, additional, Ogdie, AR, additional, Tillett, W, additional, Gisondi, P, additional, Ink, B, additional, Prickett, AR, additional, Assudani, D, additional, Bajracharya, R, additional, Taieb, V, additional, Willems, D, additional, Lambert, J, additional, and Walsh, JA, additional

Published
2022
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26. Le bimékizumab réduit fatigue et douleur chez les patients atteints de rhumatisme psoriasique actif, naïfs de biologiques ou avec réponse inadéquate (RI) aux anti-TNF : résultats à 16 semaines de 2 études de phase III randomisées, contrôlées par placebo

Author

Gossec, L., primary, Husni, M.E., additional, Mease, P.J., additional, Merola, J.F., additional, Behrens, F., additional, Favalli, E.G., additional, McGonagle, D., additional, Tillett, W., additional, Tsuji, S., additional, Ink, B., additional, Assudani, D., additional, Bajracharya, R., additional, Coarse, J., additional, and Lambert, J., additional

Published
2022
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27. L’atteinte de critères cliniques plus stricts est associée à de plus importantes améliorations des critères patients (fonction physique, douleur) chez les patients atteints de rhumatisme psoriasique actif : résultats à 16 semaines de 2 études de phase III

Author

Goupille, P., primary, Walsh, J.A., additional, Coates, L.C., additional, Mease, P.J., additional, Merola, J.F., additional, Nash, P., additional, Ogdie, A.R., additional, Tillett, W., additional, Gisondi, P., additional, Ink, B., additional, Assudani, D., additional, Bajracharya, R., additional, Lambert, J., additional, Taieb, V., additional, Willems, D., additional, and Kristensen, L.E., additional

Published
2022
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28. Efficacité et tolérance à long terme de l’upadacitinib chez les patients présentant un rhumatisme psoriasique réfractaire aux traitements biologiques : résultats à 2 ans de l’étude de phase III SELECT-PsA 2

Author

Mease, P.J., primary, Setty, A., additional, Papp, K., additional, Van Den Bosch, F., additional, Tsuji, S., additional, Keiserman, M., additional, Bu, X., additional, Chen, L., additional, Mccaskill, R., additional, McDearmon-Blondell, E., additional, Wung, P., additional, Richette, P., additional, and Tillett, W., additional

Published
2022
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29. Le bimékizumab améliore la qualité de vie chez les patients atteints de rhumatisme psoriasique actif, naïfs de biologiques ou avec réponse inadéquate aux anti-TNF : résultats à 16 semaines de 2 études de phase III randomisées, contrôlées par placebo

Author

Gossec, L., primary, Gladman, D.D., additional, Kristensen, L.E., additional, Thaçi, D., additional, Gisondi, P., additional, Husni, M.E., additional, Gottlieb, A.B., additional, Dobashi, H., additional, Ink, B., additional, Assudani, D., additional, Bajracharya, R., additional, Coarse, J., additional, Lambert, J., additional, and Tillett, W., additional

Published
2022
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30. The evolving demographics of patients recruited to phase iii randomised controlled trials of biologic/ targeted synthetic disease-modifying anti-rheumatic drugs in psoriatic arthritis.

Author

Zhu W., Ayoub S., Morand E., Tillett W., Antony A., Zhu W., Ayoub S., Morand E., Tillett W., and Antony A.

Abstract

Aim: To describe the evolving demographics of patients recruited to phase 3 randomised controlled trials (RCTs) of biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in Psoriatic Arthritis (PsA). Method(s): A scoping review was conducted to identify placebo-controlled phase 3 RCTs of b/tsDMARDs in PsA published up to January 2022. Inclusion criteria for all studies were reviewed. Demographic data were extracted from the active treatment arms by two authors (WZ, AA) including: age, sex, race, disease duration, swollen joint count (SJC), tender joint count (TJC), and Health Assessment Questionnaire - Disability Index (HAQ-DI). The date of study initiation and countries in which the studies were conducted were extracted from clinicaltrials.gov. Descriptive statistics were used to evaluate the data. Result(s): Thirty-eight eligible RCTs were identified; four were excluded due to a lack of published initiation date. Thirteen (38.2%) were b/tsDMARD-naive cohorts. The mean age of patients did not change over time, however, the proportion of females increased. Females represented 29-43.7% of participants in studies which began recruitment in 2000/01 and 47.7-55.4% in studies recruiting from 2018/19. The mean (range) of countries involved increased from 2 (1-5) in 2000/01 to 26 (14-39) in 2018/19, but 94.0-97.3% of patients in studies from the 2018/19 period were white. The highest percentage of non-white participants in the treatment arm of an RCT was 19.8%. There was minimal evolution in the mean SJC/TJC/HAQ-DI over two decades. Other variables extracted were excluded from analysis due to significant variation in reporting. Conclusion(s): The recruitment of female PsA patients to placebo-controlled phase 3 PsA RCTs has increased over time. Despite the increase in the number of countries in which RCTs are conducted, non-white patients remain sub-optimally represented in treatment data. TJC/SJC/HAQ-DI stability over decades may reflect the inclus

Published
2022

31. Les schémas thérapeutiques en vie réelle reflètent-ils les recommandations pour le rhumatisme psoriasique ? Résultats de l'étude PRO-SPIRIT.

Author

Tillett, W., Nisar, M., Chandran, V., Ng, K.J., Ngantcha, M., Laedermann, C., Moyano, S., Alten, R., Kristensen, L.E., McGonagle, D., and Constantin, A.

Abstract

Le « Group for Research and Assessment of Psoriasis and Psoriatic Arthritis » (GRAPPA) et l'« European Alliance of Associations for Rheumatology » (EULAR) ont élaboré des recommandations pour le traitement du rhumatisme psoriasique (PsA) basées sur les données actuelles. Tous les médicaments antirhumatismaux biologiques modificateurs de la maladie (bDMARDs) sont recommandés à niveau égal pour l'arthrite périphérique. Les inhibiteurs (i) de l'interleukine 17 (IL-17) et de l'IL-12/23 sont à préférer aux inhibiteurs du facteur de nécrose tumorale (TNFi) en cas de large atteinte cutanée. Les IL-12/23i ne sont pas recommandés en cas de manifestations axiales. PRO-SPIRIT est la première étude observationnelle prospective internationale à large effectif dans le PsA. Les résultats de l'étude révèlent que les modalités de traitement en vie réelle reflètent les recommandations décrites dans le PsA. PRO-SPIRIT a inclus des adultes atteints de PsA entre 2019 et 2022, ayant initié ou été switché vers un médicament antirhumatismal biologique ou synthétique ciblé (b/tsDMARD). Les groupes de traitement comprenaient les inhibiteurs du TNF (TNFi), de l'IL-17A (IL-17Ai), de l'IL-12/23 (IL-12/23i), de l'IL-23 (IL-23i), les inhibiteurs de Janus kinase (JAKi), et de la phosphodiestérase-4 (PDE4i). Le mode d'action (MoA) était à la discrétion du médecin traitant. Les caractéristiques démographiques des patients, l'activité de la maladie, les caractéristiques du traitement et les résultats cliniques et rapportés par les patients ont été recueillis à l'inclusion. Des résultats descriptifs sont présentés. Les valeurs manquantes à l'inclusion ont été imputées. L'analyse inclut 1 192 patients atteints de PsA traités par différents MoA. Les patients présentant une arthrite (définie par un nombre d'articulations gonflées (NAG) et douloureuses (NAD) ≥ 5) étaient également répartis entre les classes thérapeutiques, sauf dans le groupe PDE4i (pourcentage plus faible). Les patients recevant des IL-17Ai présentaient fréquemment une atteinte articulaire, cutanée et unguéale. Les patients avec une atteinte cutanée plus importante (surface corporelle (BSA) ≥ 3 %) et unguéale étaient plus fréquemment traités par IL-17Ai et IL-23i, moins par JAKi. Les patients recevant des JAKi présentaient plus d'atteintes articulaires et axiales, et moins d'atteintes cutanées. Après les IL-23i, les PDE4i avaient la deuxième proportion la plus élevée de patients avec une atteinte unguéale. Les patients traités par PDE4i étaient peu nombreux et rapportaient généralement moins d'atteintes actives. Les résultats par ligne de traitement ont montré qu'une proportion plus importante de patients était traitée par IL-12/23i, JAKi et IL-17Ai après un traitement antérieur par b/tsDMARDs. En général, les patients présentaient une maladie polyarticulaire à l'inclusion. Les patients avec une atteinte cutanée et unguéale étaient plus fréquemment traités par IL-17Ai et IL-23i que par TNFi et JAKi. Les patients présentant des manifestations axiales étaient plus fréquemment traités par IL-17Ai et JAKi que par IL-12/23i et IL-23i. Ces résultats contribuent à alimenter les données sur les schémas thérapeutiques dans le PsA en vie réelle ainsi qu'aux recommandations pour guider un traitement individualisé du PsA. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Comparaison de l'efficacité précoce (3 mois) et maintenue (12 mois) de 5 classes thérapeutiques différentes dans une grande cohorte multinationale de patients atteints de rhumatisme psoriasique en vie réelle.

Author

Tillett, W., Alten, R., Lubrano, E., Ng, K.J., Ngantcha, M., Torre, I. De La, Kennedy, D., Gullick, N., McGonagle, D., and Morel, J.

Abstract

PRO-SPIRIT (Psoriatic Arthritis Observational Study of Persistence of Treatment) est une étude prospective multinationale qui évalue l'utilisation en vie réelle des antirhumatismaux modificateurs de la maladie biologiques ou synthétiques ciblés (b/tsDMARDs) pour traiter le rhumatisme psoriasique (RP). Le critère principal était le maintien thérapeutique à 24 mois chez les patients (pts) débutant un nouveau traitement par b/tsDMARD. Les critères secondaires incluaient les données descriptives et comparatives de l'efficacité et de la survie à 3, 12 et 24 mois. Cette analyse intermédiaire présente : (1) les caractéristiques à l'inclusion ; et (2) la comparaison de l'efficacité des traitements du RP à 3 (M3) et 12 (M12) mois. Les résultats à M12 (175 sites, 6 pays) ont été obtenus le 11 décembre 2023. Les données descriptives (caractéristiques à l'inclusion) et comparatives (ajustées par rapport à l'inclusion) de l'efficacité en vie réelle ont été analysées pour évaluer les groupes de traitement > 10 % de l'effectif total : ixékizumab (IXE), sécukinumab (SECU) 150 ou 300 mg, classe des IL-17Ai (IXE et SECU), inhibiteurs du facteur de nécrose tumorale (TNFi), IL-12/23i, IL-23i et inhibiteurs des Janus kinases (JAKi). Au total, 1192 pts ont été inclus. L'activité de la maladie et les caractéristiques à l'inclusion étaient similaires. Une plus faible proportion de pts JAKi avait une atteinte de la surface corporelle (BSA) ≥ 3 % à l'inclusion (25,8 %). Les analyses comparatives sur l'efficacité ont montré que : (a) sur les articulations, IXE était aussi efficace que les TNFi et JAKi à M3 et M12 quant à l'amélioration des scores d'activité clinique de la maladie pour le RP (cDAPSA), et au nombre d'articulations douloureuses (NAD) et gonflées (NAG). Une utilisation concomitante plus élevée de csDMARD à l'inclusion et des améliorations du NAD (M12) peuvent avoir contribué aux scores cDAPSA observés avec les JAKi ; l'amélioration du cDAPSA était moins importante en comparant à M12 les TNFi et JAKi avec toute la classe des IL-17Ai. À M3, IXE et la classe des IL-17Ai étaient significativement plus efficaces pour améliorer les scores cDAPSA, le NAD et le NAG que les traitements par IL-12/23i et IL-23i (regroupés), ce qui indique une réponse plus rapide à IXE et aux IL-17Ai ; (b) sur la peau, IXE a permis d'obtenir une plus grande amélioration du BSA en comparaison avec les TNFi à M3 (IXE : −4,1 [−4,8 à −3,4] ; TNFi : −2,6 [−3,3 à −2,0]) et M12 (−4,4 [−4,9 à −3,8] ; −3,5 [−4,0 à 3,0]). PRO-SPIRIT confirme que l'IXE est aussi efficace que les TNFi et les JAKi pour améliorer l'activité de la maladie articulaire chez les pts atteints de RP, alors même que la sous-population IXE avait reçu un nombre plus important de b/tsDMARDs antérieurs, que la maladie était plus ancienne que les pts traités par un TNFi, et que moins de pts étaient traités par csDMARDs concomitants en comparaison aux groupes traités par TNFi et JAKi. L'étude montre aussi qu'IXE et la classe des IL-17Ai permettent une amélioration plus rapide des scores cDAPSA en comparaison avec les IL-12/23i ou IL-23i, et un bénéfice manifestement supérieur sur le BSA par rapport à un TNFi. [ABSTRACT FROM AUTHOR]

Published
2024
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34. AB0881 Guselkumab Provides Sustained Improvements in Health-Related Quality of Life in Patients With Active Psoriatic Arthritis Through 2 Years of DISCOVER-2

Author

Curtis, J., primary, McInnes, I., additional, Rahman, P., additional, Gladman, D. D., additional, Yang, F., additional, Peterson, S., additional, Kollmeier, A., additional, Shiff, N., additional, Han, C., additional, Shawi, M., additional, Tillett, W., additional, and Mease, P. J., additional

Published
2022
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36. AB0888 Guselkumab Provides Sustained Improvements in Work Productivity and Daily Activity in Patients With Active Psoriatic Arthritis Through 2 Years of DISCOVER-2

Author

Curtis, J., primary, Mcinnes, I., additional, Rahman, P., additional, Gladman, D. D., additional, Yang, F., additional, Peterson, S., additional, Kollmeier, A., additional, Shiff, N., additional, Han, C., additional, Shawi, M., additional, Tillett, W., additional, and Mease, P. J., additional

Published
2022
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37. POS1041 LONG-TERM EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS REFRACTORY TO BIOLOGIC THERAPIES: 2-YEAR RESULTS FROM THE PHASE 3 SELECT-PsA 2 STUDY

Author

Mease, P. J., primary, Setty, A., additional, Papp, K., additional, Van den Bosch, F., additional, Tsuji, S., additional, Keiserman, M., additional, Bu, X., additional, Chen, L., additional, Mccaskill, R., additional, Mcdearmon-Blondell, E., additional, Wung, P., additional, and Tillett, W., additional

Published
2022
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39. POS1055 IDENTIFICATION OF PsA PHENOTYPES WITH MACHINE LEARNING ANALYTICS USING DATA FROM A PHASE 3 CLINICAL TRIAL PROGRAMME OF GUSELKUMAB IN A BIO-NAÏVE PATIENT POPULATION

Author

Richette, P., primary, Vis, M., additional, Ohrndorf, S., additional, Tillett, W., additional, Neuhold, M., additional, Van Speybroeck, M., additional, Theander, E., additional, Noel, W., additional, Shawi, M., additional, Kollmeier, A., additional, and Zabotti, A., additional

Published
2022
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43. POS1051 TO WHAT EXTENT ARE BASELINE CHARACTERISTICS IN BIOLOGIC-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS ASSOCIATED WITH ACHIEVEMENT OF MINIMAL DISEASE ACTIVITY AT WEEK 24 OF GUSELKUMAB TREATMENT: A POST HOC ANALYSIS OF THE PHASE IIIb COSMOS CLINICAL TRIAL

Author

Tillett, W., primary, Ohrndorf, S., additional, Ramírez, J., additional, Neuhold, M., additional, Wapenaar, R., additional, Theander, E., additional, Contre, C., additional, Sharaf, M., additional, Shawi, M., additional, and Vis, M., additional

Published
2022
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49. Performance and Predictors of Minimal Disease Activity Response in Peripheral Spondyloarthritis Patients Treated With Adalimumab

Author

Coates, LC, Abraham, S, Tillett, W, Mease, PJ, Ramiro, S, Wu, T, Wang, X, Pangan, AL, and Song, I-H

Abstract

Objectives: To examine concurrent validity and discrimination of modified minimal disease activity (mMDA) criteria in peripheral spondyloarthritis (pSpA) following OMERACT filter principles and determine predictors of mMDA response. Methods: Four mMDA versions were derived in the ABILITY‐2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis. To assess concurrent validity, mMDA versions were correlated with Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global. Treatment discrimination was assessed between adalimumab and placebo at week 12. Multiple logistic regression was used to determine baseline predictors of long‐term mMDA responses and sustained mMDA. Results: The four mMDA versions showed a stronger positive correlation with PSpARC remission (rtet>0.95) versus ASDAS ID (rtet>0.75) at week 12 and years 1‐3 and were able to show discrimination (p Conclusions: All four versions of mMDA showed concurrent validity and discriminated well between adalimumab and placebo treatment groups. Early mMDA response is a more consistent predictor of long‐term mMDA achievement than baseline characteristics. The 5 of 6 versions of mMDA could be an appropriate treatment target in pSpA patients.

Published
2022
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50. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL)

Author

Coates, L.C., Tillett, W., D'Agostino, M.A., Rahman, P., Behrens, Frank, McDearmon-Blondell, E.L., Bu, X., Chen, L., Kapoor, M., Conaghan, P.G., Mease, P., and Publica

Abstract

Background: Many patients with psoriatic arthritis do not reach minimal disease activity (MDA) on methotrexate alone. This phase 4 open-label study aimed to compare attainment of MDA following introduction of adalimumab with methotrexate escalation in patients with psoriatic arthritis who do not reach MDA after an initial methotrexate course (≤15 mg every week). Methods: CONTROL was a phase 4, randomised, two-part, open-label study conducted in 14 countries and 46 sites. We recruited patients with confirmed active psoriatic arthritis, naive to biologic disease-modifying antirheumatic drugs, with an inadequate response to 15 mg or less of methotrexate. In part 1, patients were randomly assigned (1:1) to receive either methotrexate 15 mg (oral or subcutaneous) every week with the addition of adalimumab 40 mg (subcutaneously) every other week (adalimumab plus methotrexate group) or methotrexate (oral or subcutaneous) escalation up to 25 mg every week (escalated methotrexate group). Randomisation was done using Interactive Response Technology and stratified by the duration of methotrexate treatment (≤3 months and >3 months). In this open-label study there was no masking; participants, people giving the interventions, those assessing outcomes, and those analysing the data were aware of group assignment. The primary endpoint was the proportion of patients who reached MDA at 16 weeks. After 16 weeks (part 2), patients who reached MDA (responders) had their current therapy maintained or modified, wheras patients who did not reach MDA (non-responders) had their therapy escalated until 32 weeks. The primary endpoint in part 2 was the proportion of patients who reached MDA at 32 weeks, analysed in all patients who received one or more doses of study drug. The study is registered with ClinicalTrials.gov, NCT02814175. Findings: Between Aug 5, 2016, and March 19, 2020, 245 of 287 patients initially assessed were enrolled in the study (50% men and 50% women; 92% of patients were White). 123 patients were randomly assigned to receive adalimumab plus methotrexate and 122 patients to receive escalated methotrexate. All 245 patients were included in the primary analysis, and 227 completed part 1 and entered part 2. A significantly higher proportion of patients reached MDA at 16 weeks in the adalimumab plus methotrexate group (51 [41%] patients) compared with the escalated methotrexate group (16 [13%] patients; p

Published
2022

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