Presentation
Secukinumab Treatment of Psoriatic Arthritis and Moderate to Severe Psoriasis Relieves Anxiety/Depression up to 52 Weeks: An Overview from Secukinumab Phase 3 Clinical Trials. American College of Rheumatology (ACR) Annual Meeting, San Diego CA, Nov. 2017. Arthritis Rheumatol 2017
American College of Rheumatology (ACR) Annual Meeting
(2017)
Abstract
Background/Purpose: Secukinumab (SEC), a fully human monoclonal antibody selectively neutralizing interleukin-17A, exhibits significant efficacy, with a favorable safety profile, in the treatment of psoriatic arthritis (PsA) and moderate to severe psoriasis. SEC has a rapid onset of action and demonstrates sustained responses. PsA and psoriasis patients are at greater risk for psychological distress, including depression and suicidality. Previous analysis, using pooled data from phase 3 studies FIXTURE and ERASURE, reported high and sustained relief from anxiety/depression in psoriasis patients treated with SEC 300 mg up to Week (Wk) 52 (~80% of patients reported not being anxious/depressed) from the EuroQol 5-dimensional (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) and 3-level questionnaire (EQ-5D-3L). Here, we aim to confirm these results in additional phase 3 SEC trials in patients with PsA and psoriasis.
Methods: Results of the ‘Anxiety/Depression’ dimension ("not anxious/depressed", "moderately anxious/depressed", or "extremely anxious/depressed) of EQ-5D-3L were derived from three phase 3 studies using an approved SEC dose: FUTURE 1 and FUTURE 2, two randomized, double-blind clinical trials, comparing SEC 150 mg to placebo in active PsA; and CLEAR, a multicenter, double-blind, parallel-group study comparing SEC 300 mg to ustekinumab in moderate to severe psoriasis. The proportions of patients reporting as not being anxious/depressed are described as observed for each individual study up to Wk 52.
Results: In FUTURE 1, 76/200 (38.0%) of PsA patients treated with SEC 150 mg reported being not anxious/depressed at baseline, increasing to 99/192 (51.6%) at Wk 4 and 109/184 (59.2%) at Wk 52 (Fig. 1). Similarly, in FUTURE 2, 32/100 (32.0%) and 41/99 (41.4%) of PsA patients treated with SEC 150 mg or 300 mg, respectively reported being not anxious/depressed at baseline, increasing to 51/99 (51.5%) and 52/95 ( 54.7%) at Wk 4 and 49/89 (55.1%) and 55/95 (57.9%) at Wk 52 (Fig. 1). In the CLEAR study, 154/326 (47.2%) psoriasis patients treated SEC 300 mg reported being not anxious/depressed at baseline, and this increased to 238/322 (73.9%) at Wk 4, 263/326 (80.7%) at Wk 16, and was sustained up to Wk 52 (237/292, 81.2%) (Fig. 1).
Conclusion: This analysis of the patient-reported EQ-5D-3L anxiety/depression measure from three phase 3 SEC trials showed consistently higher anxiety/depression burden among patients with PsA than among those with moderate to severe psoriasis; however, it also indicates that SEC treatment improves and provides sustained relief from anxiety/depression among all treated patients, regardless of their disease, up to 1 year.
Disciplines
Publication Date
November, 2017
Citation Information
Philip Mease and et. al.. "Secukinumab Treatment of Psoriatic Arthritis and Moderate to Severe Psoriasis Relieves Anxiety/Depression up to 52 Weeks: An Overview from Secukinumab Phase 3 Clinical Trials. American College of Rheumatology (ACR) Annual Meeting, San Diego CA, Nov. 2017. Arthritis Rheumatol 2017" American College of Rheumatology (ACR) Annual Meeting (2017) Available at: http://works.bepress.com/philip-mease/160/