POS1051 SECUKINUMAB IMPROVES PHYSICAL FUNCTION AND INHIBITS STRUCTURAL DAMAGE IN PsA PATIENTS WITH SUSTAINED REMISSION OR LOW DISEASE ACTIVITY: RESULTS FROM A PHASE 3 STUDY
Authors: L. C. Coates, P. J. Mease, D. D. Gladman, S. Navarra, W. Bao, C. Gaillez
Journal: Annals of the Rheumatic Diseases (2021)

Background: Disease Activity Index for Psoriatic Arthritis (DAPSA) or the minimal disease activity (MDA) are considered for defining remission (REM) or low disease activity (LDA) in secukinumab (SEC) treated patients (pts) with PsA (Psoriatic Arthritis). 1 Currently, limited SEC data are available on pts with PsA achieving sustained REM in clinical trials or real-world evidence, using these stringent criteria. Objectives: To report an exploratory analysis on achievement of sustained REM/LDA in pts with PsA treated with SEC and impact on structural outcomes, physical function and health-related quality of life (HRQoL) in the FUTURE 5 study ( NCT02404350 ). Methods: FUTURE 5 is a randomised, double-blind, placebo-controlled 2-year phase 3 trial in pts with active PsA. 2 Pts randomised to SEC 150 mg could be escalated to 300 mg from Week (Wk) 52 to 104, based on investigators’ judgement. The pts were categorised as either not achieving REM/LDA, achieving it once only or sustained REM/LDA, which was defined as pts who achieved REM/LDA between Wks 24-52 and maintained the same response at least 2 of the next 6 visits (visit every 8 Wks). Of pts who did not achieve REM/LDA, achieved REM/LDA (VLDA, DAPSA REM, MDA, DAPSA LDA+REM) between Wk 24 and 52, the relationship between absence of REM/LDA, REM/LDA, sustained REM/LDA, proportion of pts with non-radiographic progression (assessed using the van der Heijde [mTSS]), physical function (health assessment questionnaire disability index [HAQ-DI]), and short form-36 physical component score [SF-36 PCS]) 3 were assessed. Results: In total, 996 pts were randomised to one of 4 treatment groups: SEC 300 mg loading dose (LD; N=222), SEC 150 mg LD (N=220), SEC 150 mg no loading dose (NL; N=222), and placebo (N=332). The baseline clinical characteristics were comparable across treatment groups. Majority of pts could achieve either sustained MDA/sustained DAPSA LDA+REM (Figure 1). Pts achieving REM/LDA, whether at one visit or consistently, showed improved physical function and SF36-PCS at Wk 104. 3 A high proportion of pts did not show radiographic progression at Wk 104 irrespective of achievement of REM/LDA category (Table 1 ). Conclusion: The majority of patients treated with secukinumab were able to achieve sustained LDA. Sustained LDA/REM was associated with improved HRQoL, physical function and inhibition of structural damage progression. References: [1]Coates LC, et al. J Rheumatol. 2018;46(1):38–42. [2]Van der Heijde D, et al. Rheumatology . 2020;59(6):1325–1334. [3]Coates L, et al. [0353]. Arthritis Rheumatol . 2020;72 (suppl 10). Figure 1. Proportion of patients achieving VLDA/MDA/DAPSA REM/DAPSA REM+LDASus-tained REM/LDA was defined if the same response was achieved at least 2 out of the next 6 visits (every 8 weeks), respectively. DAPSA, Disease activity in Psoriatic Arthritis; LD, loading dose; LDA, Low Disease Activity; MDA, Minimal Disease Activity; N, number of randomised patients assessed at both Week 24 and 104; NL, without loading dose; REM, remission; SEC, secukinumab; VLDA, Very Low Disease Activity Table 1. Percentage of vdH-mTSS no progression at Week 104 (change from baseline ≤0.5) by REM/LDA and sustained REM/LDA status REM and LDA composite indices, n (% ) Treatment group No REM/LDA REM/LDA only once Sustained REM/LDA MDA SEC 150 mg LD 64 (75.3) 16 (80.0) 76 (86.4) SEC 150 mg NL 56 (75.7) 15 (78.9) 69 (82.1) SEC 300 mg LD 58 (79.5) 19 (95.0) 100 (94.3) VLDA SEC 150 mg LD 108 (78.8) 15 (83.3) 30 (88.2) SEC 150 mg NL 95 (75.4) 13 (81.3) 32 (91.4) SEC 300 mg LD 115 (84.6) 17 (94.4) 45 (100.0) DAPSA REM SEC 150 mg LD 77 (76.2) 11 (78.6) 46 (92.0) SEC 150 mg NL 65 (71.4) 10 (76.9) 50 (87.7) SEC 300 mg LD 82 (83.7) 14 (93.3) 63 (96.9) DAPSA LDA + REM SEC 150 mg LD 29 (70.7) 16 (84.2) 80 (84.2) SEC 150 mg NL 23 (71.9) 15 (75.0) 79 (79.0) SEC 300 mg LD 39 (88.6) 21 (84.0) 97 (89.0) Sustained REM/LDA was defined if the same response was achieved at least twice out of the next 6 visits (every 8 weeks), respectively. n, number of evaluable patients; vdH-mTSS, van der Heijde- modified total Sharp score Disclosure of Interests: Laura C Coates Consultant of: Abbvie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer and UCB, Grant/research support from: Abbvie, Celgene, Lilly, Novartis and Pfizer, Philip J Mease Speakers bureau: AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Galapagos, Celgene, Genentech, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, and UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN, and UCB, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB, Grant/research support from: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB, Sandra Navarra Speakers bureau: Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, and Astellas, Consultant of: Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, and Astellas, Weibin Bao Shareholder of: Novartis, Employee of: Novartis, Corine Gaillez Shareholder of: Novartis and BMS, Employee of: Novartis.