Treatment with interleukin (IL)-17A inhibitor secukinumab as first-line monotherapy for concomitant moderate to severe plaque psoriasis and active psoriatic arthritis (PsA) was associated with higher responses than treatment with tumor necrosis factor-alpha inhibitor adalimumab, but both treatments showed generally similar efficacy in this patient population, according to results from a subgroup analysis of the phase 3b EXCEED trial published in the British Journal of Dermatology.
The analysis of the EXCEED trial included patients (mean age, 47.9 years; women, 41.7%) with concomitant moderate to severe plaque psoriasis defined as 1 or more plaques with diameter 2 cm or more or history of plaque psoriasis or nail changes. Also included were patients with active PsA, defined as 3 or more tender joints and 3 or more swollen joints, for a total of 211 patients.
Participants were randomly assigned to either 300 mg secukinumab (n=110) or 40 mg adalimumab (n=101) delivered via subcutaneous injection. Secukinumab was delivered from weeks 1 through 4 and then every 4 weeks until 48 weeks, and adalimumab was delivered every 2 weeks from baseline until week 50.
Researchers compared the 2 groups in regard to the percentage of patients who experienced 20% or greater improvement in the American College of Rheumatology (ACR) response by week 52. Key secondary endpoints included the Psoriasis Area and Severity Index (PASI) 90 response, ACR 50 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, and enthesitis resolution.
Approximately 5.5% of the secukinumab-treated patients and 17.8% of the adalimumab-treated patients discontinued treatment during 50 weeks. Reasons for discontinuation for secukinumab vs adalimumab included lack of efficacy [0.9% vs 6.9%, respectively) and patient/guardian decision (3.6% vs 5.9%). A significantly higher percentage of patients remained on secukinumab than adalimumab until the last 50-week dosing visit (P =.0005).
At week 52, the ACR 20 response rates were 76.4% for patients who received secukinumab vs 68.3% for patients who received adalimumab (odds ratio [OR], 1.53; 95% CI, 0.83–2.83; P =.175). The PASI 90 responses at follow-up were 68.6% for secukinumab and 41.7% adalimumab, demonstrating a clear and significant benefit with secukinumab (OR, 3.21; 95% CI, 1.80–5.71; P <.001), the study authors noted.
In addition, the ACR 50 responses were 54.5% for secukinumab and 49.3% for adalimumab (OR, 1.28; 95% CI, 0.73–2.22; P =.386). Enthesitis resolution was reported in 74.5% of patients in the secukinumab arm and 66.2% of patients in the adalimumab group (OR, 1.54; 95% CI, 0.85–2.82; P =.157).
Improvement in combined ACR 50 and PASI 100 response was observed in 28.2% of patients in the secukinumab group vs 17.7% in the adalimumab arm (OR, 1.92; 95% CI, 0.97–3.79; P =.06).
No differences were observed between the secukinumab and adalimumab treatment arms in terms of the mean change in the HAQ-DI from baseline to week 52 (-0.60 vs -0.56, respectively; OR, -0.04; 95% CI, -0.19–0.10; P =.532).
A limitation of this study was its monotherapy design, which may affect the real-world generalizability given concomitant methotrexate is often used in PsA, the researchers wrote.
The researchers concluded the findings support the notion “IL-17 inhibitors offer a comprehensive biological treatment profile to manage the concomitant features of psoriasis and PsA.”
Disclosure: This clinical trial was supported by Novartis Pharma AG. Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Gottlieb AB, Merola JF, Reich K, et al. Efficacy of secukinumab and adalimumab in patients with psoriatic arthritis and concomitant moderate-to-severe plaque psoriasis: results from EXCEED, a randomized, double-blind head-to-head monotherapy study. Br J Dermatol. Published online April 29, 2021. doi:10.1111/bjd.20413