Secukinumab achievement of psoriatic arthritis disease activity score- (PASDAS) related remission: two-year results from a Phase III study

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Secukinumab achievement of psoriatic arthritis disease activity score- (PASDAS) related remission: two-year results from a Phase III study

Presenters: Coates LC1, Gladman DD2, Nash P3, Fitzgerald O4, Kavanaugh A5, Rasouliyan L6, Pricop L7, Ding K7, Gaillez C8 (on behalf of the FUTURE 2 Study Group)

Affiliations: 1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; 2Toronto Western Hospital, Toronto, ON, Canada; 3University of Queensland, Brisbane, Australia; 4St. Vincent’s University Hospital, Dublin, Ireland; 5UC San Diego School of Medicine, La Jolla, CA; 6RTI Health Solutions, Barcelona, Spain; 7Novartis Pharmaceuticals Corporation, East Hanover, NJ; 8Novartis Pharma AG, Basel, Switzerland.

Background/Objective: Psoriatic Arthritis Disease Activity Score (PASDAS) assessing multiple facets of psoriatic arthritis (PsA) has been shown to distinguish treatment effect and perform better in statistical terms than traditional joint-only indices and could be used as a treatment target in clinical trials in PsA. Secukinumab significantly improved the signs and symptoms of PsA over 104 weeks in the FUTURE 2 study. This post-hoc analysis assessed the ability of secukinumab to achieve low disease activity (LDA) or remission (REM) using PASDAS through 104 weeks in the FUTURE 2 study.

Methods: The FUTURE 2 study design was previously published. PASDAS index is derived from Physician’s Global Visual Analog Scale, patient’s global VAS, SF-36 PCS, tender and swollen joint counts, Leeds enthesitis count, dactylitis count and c-reactive protein level with validated cut-points for high disease activity (HDA ?5.4), moderate disease activity (3.2< MoDA <5.4), 1.9<LDA ?3.2 and REM ?1.9.3

Results: PASDAS scores at baseline was similar across the three treatment groups. In the overall population at Week 16, PASDAS REM, LDA, and MoDA were achieved in 15.6 percent, 22.9 percent, and 49.0 percent, respectively, of patients treated with secukinumab 300 mg; of patients treated with secukinumab 150mg, 15.2 percent, 19.2 percent, and 42.4 percent, respectively; and of patients given placebo, 2.3 percent, 13.8 percent, and 44.8 percent, respectively. At Week 104, REM was achieved in 22.9 percent and 14.3 percent of patients treated with secukinumab 300mg and 150mg, respectively. In anti–TNF-naïve patients at Week 16, PASDAS REM, LDA, and MoDA were achieved in 18.5 percent, 27.7 percent, and 46.2 percent, respectively, of patients treated with secukinumab 300mg; of patients treated with secukinumab 150mg, 22.2 percent, 20.6 percent, and 42.9 percent, respectively; and of patients given placebo, 3.5 percent, 14.0 percent, and 45.6 percent, respectively. At Week 104 in anti–TNF-naïve patients, REM was achieved in 29.1 percent and 17.0 percent of patients treated with secukinumab 300mg and 150mg, respectively. In anti–TNF-inadequate response (IR) patients at Week 16, PASDAS REM, LDA, and MoDA were achieved in 9.7 percent, 12.9 percent, and 54.8 percent, respectively, of patients treated with secukinumab 300mg; of patients treated with secukinumab 150mg, 2.8 percent, 16.7 percent, and 41.7 percent, respectively; of patients given placebo, 0 percent, 13.3 percent, and 43.3 percent, respectively. At Week 104 in anti–TNF-IR patients, REM was achieved in 10.7 percent and 8.3 percent of patients treated with secukinumab 300mg and 150mg, respectively. The proportion of patients achieving PASDAS REM/LDA at Weeks 16 and 104 was similar, irrespective of time since first diagnosis, for both secukinumab doses. Secukinumab treated patients achieving PASDAS REM had significantly greater improvements in function, physical- and mental-health quality of life, and fatigue compared to HDA through Week 104.

Conclusion: At Week 16, PASDAS REM and LDA were achieved in 38.5 percent and 34.4 percent of patients treated with secukinumab 300mg and 150mg, respectively, versus 16.1 percent in the placebo group, with approximately 50 percent of patients achieving PASDAS REM and LDA in both secukinumab groups at Week 104. A higher proportion of anti–TNF-naïve patients treated with secukinumab achieved PASDAS REM or LDA than those treated with anti–TNF-IR through Week 104. Secukinumab treated patients achieving PASDAS REM had significantly greater improvements in function, quality of life, and fatigue.

Funding: This research was sponsored by Novartis Pharma AG in Basel, Switzerland.

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