Laura C Coates1, Philip J Mease2, Laure Gossec3, Bruce Kirkham4, Bintu Sherif5, Corine Gaillez6, Shephard Mpofu6, Steffen M Jugl6, Chetan Karyekar7, Kunal K Gandhi7. 1. University of Oxford, Oxford, UK. 2. Swedish Medical Centre and University of Washington, Seattle. 3. Sorbonne Universités, UPMC Université Paris 06, GRC-UPMC 08, and Pitié Salpêtrière Hospital, AP-HP, Paris, France. 4. Guy's and St Thomas' NHS Foundation Trust, London, UK. 5. RTI Health Solutions, Research Triangle Park, North Carolina. 6. Novartis Pharma AG, Basel, Switzerland. 7. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Abstract
OBJECTIVE: To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study. METHODS:Patients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [anti-TNF]-naive and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at weeks 16, 24, 52, and 104. Function and patient-reported outcomes (PROs), including health-related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders. RESULTS: Overall, 28% of patients (27 of 98) and 23% (23 of 100) achieved MDA at week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9 of 94) with placebo. In the anti-TNF-naive cohort, a higher proportion of patients achieved MDA at week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus with placebo (3%). At week 16, 27.1% of MDA responders (16 of 59) achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8 of 27] and 26% [6 of 23], respectively) versus placebo (22% [2 of 9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to nonresponders through 2 years. CONCLUSION: A greater proportion of patients achieved MDA with secukinumab versus placebo at week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.
RCT Entities:
OBJECTIVE: To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study. METHODS:Patients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumornecrosis factor [anti-TNF]-naive and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at weeks 16, 24, 52, and 104. Function and patient-reported outcomes (PROs), including health-related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders. RESULTS: Overall, 28% of patients (27 of 98) and 23% (23 of 100) achieved MDA at week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9 of 94) with placebo. In the anti-TNF-naive cohort, a higher proportion of patients achieved MDA at week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus with placebo (3%). At week 16, 27.1% of MDA responders (16 of 59) achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8 of 27] and 26% [6 of 23], respectively) versus placebo (22% [2 of 9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to nonresponders through 2 years. CONCLUSION: A greater proportion of patients achieved MDA with secukinumab versus placebo at week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.
Authors: Dominique I Dabija; Jacquelyn S Pennings; Kristin R Archer; Gregory D Ayers; Laurence D Higgins; John E Kuhn; Keith M Baumgarten; Elizabeth Matzkin; Nitin B Jain Journal: Clin Orthop Relat Res Date: 2019-08 Impact factor: 4.176
Authors: L C Coates; D D Gladman; P Nash; O FitzGerald; A Kavanaugh; T K Kvien; L Gossec; V Strand; L Rasouliyan; L Pricop; K Ding; S M Jugl; C Gaillez Journal: Arthritis Res Ther Date: 2018-12-07 Impact factor: 5.156
Authors: Laura C Coates; Vibeke Strand; Hilary Wilson; Dennis Revicki; Brad Stolshek; Ahmed Samad; James B Chung; Dafna Gladman; Philip J Mease Journal: RMD Open Date: 2019-09-06
Authors: Roberta Ramonda; Mariagrazia Lorenzin; Antonio Carriero; Maria Sole Chimenti; Raffaele Scarpa; Antonio Marchesoni; Ennio Lubrano di Scorpaniello; Carlo Salvarani; Alberto Cauli; Angelo Semeraro; Leonardo Santo; Augusta Ortolan; Andrea Doria; Elena Fracassi; Giulia Virelli; Marco Masia; Rosalinda Fanizzi; Elisa Visalli; Giorgio Amato; Antonio Carletto; Rosario Foti Journal: RMD Open Date: 2021-02