Background Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis.1 In the prospective, randomised, double-blind CLEAR study (NCT02074982), secukinumab, a human anti-interleukin (IL)-17A monoclonal antibody, demonstrated superior efficacy (Psoriasis Area and Severity Index [PASI] 90) over ustekinumab (an IL-12/23 inhibitor) in patients with moderate-to-severe plaque psoriasis.2 We previously reported that secukinumab improved skin symptoms and physical functioning at 16 weeks (wks) in the subgroup with concomitant PsA.3
Objectives To report 52 wk results in the subgroup with concomitant PsA.
Methods Patients were randomised 1:1 to receive subcutaneous (s.c.) secukinumab 300 mg or ustekinumab (patients ≤100 kg, 45 mg sc; >100 kg, 90 mg s.c.). Secukinumab administered at baseline (BL), Wks 1, 2, and 3, and every 4 wks from Wk 4 and ustekinumab at BL, Wk 4, and every 12 wks from Wk 16. The primary endpoint was the proportion of patients achieving ≥90% reduction from BL in PASI score at Wk 16. PASI 75, PASI 90, PASI 100, and IGA mod 2011 responses over time, and changes from BL in the HAQ-DI, WPAI, and DLQI were analysed in the subgroup with concomitant PsA. Analyses used non-responder imputation for efficacy assessments and observed data for PROs.
Results Of the total 676 patients randomised, 610 (93.7%) completed 52 wks of study (secukinumab group, 312 [94.8%]; ustekinumab group, 298 [92.5%]). In overall population, the PASI 90 response was achieved by 79.0% vs. 57.6% (P<0.0001) and 74.9% vs. 60.6% (P=0.0001) patients receiving secukinumab vs. ustekinumab at Wk 16 and Wk 52, respectively. Concomitant PsA was reported in 69/337 (20.5%) and 54/339 (15.9%) patients in the secukinumab and ustekinumab groups, respectively. In the subgroup with concomitant PsA, a higher proportion of patients in the secukinumab group achieved a PASI 90 response at Wk 52 vs. ustekinumab; 77.6% vs. 63.5% (P<0.05), respectively. The mean change from baseline in HAQ-DI at Wk 52 was –0.30 with secukinumab vs. –0.13 with ustekinumab. A higher proportion of patients receiving secukinumab achieved HAQ-DI response (minimum clinically important difference) vs. ustekinumab at Wk 52 (39.4% vs. 23.5%, respectively). Greater improvements were observed in other parameters with secukinumab vs. ustekinumab in the PsA subgroup (Table).
Conclusions The significant efficacy of secukinumab vs. ustekinumab in clearing psoriasis was sustained through 52 wks in patients with moderate-to-severe plaque psoriasis. In the subgroup with concomitant PsA, secukinumab was associated with greater improvements in skin symptoms, physical functioning, quality of life, and work productivity compared with ustekinumab through 52 wks.
Gladman DD et al. Ann Rheum Dis 2005;64:14–7
Thaci D et al. J Am Acad Dermatol 2015;73(3):400–9
Gottlieb AB et al. Arthritis Rheumatol 2015;67(s10)
Disclosure of Interest A. Gottlieb Grant/research support from: (paid to Tufts Medical Center): Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck, Xenoport, Dermira, Consultant for: Amgen Inc.; Astellas, Akros, Centocor (Janssen), Inc., Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbott Labs. (Abbvie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd., Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopharm, CSL Behring Biotherapies for Life, Glaxo Smith Kline, Xenoport, Catabasis, Meiji Seika Pharma Co., Ltd, Takeda, Mitsubishi Tanabe Pharma Development America, Inc, Genentech., D. Thaçi Consultant for: AbbVie, Amgen, Biogen-Idec, Celgene Corp., Eli Lilly, Janssen-Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi, A. Blauvelt Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, and Sandoz, V. Bhosekar Employee of: Novartis, M. Milutinovic Employee of: Novartis, C. Karyekar Employee of: Novartis