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Abstract Number: 607

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

Philip J Mease1, Mark Lebwohl2, Isabelle Gilloteau3, Todd Fox3, Jaime Oliver3, Steffen Jugl3 and Alice B Gottlieb4, 1University of Washington School of Medicine and Swedish Medical Center, Seattle, WA, 2Icahn School of Medicine at Mount Sinai, New York, NY, 3Novartis Pharma AG, Basel, Switzerland, 4Department of Dermatology, New York Medical College, Vallhalla, NY

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Anxiety, Clinical practice, depression, psoriasis and psoriatic arthritis

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Session Information

Date: Sunday, November 5, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

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.

 

Figure 1. Percentages of patients with psoriatic arthritis or psoriasis reporting not being anxious/depressed on EQ-5D following treatment with secukinumab in three phase 3 clinical trials (as observed).


Disclosure: P. J. Mease, AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN, and UCB, 2,AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN, and UCB, 5,AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, 8; M. Lebwohl, Mount Sinai Medical Center, 3,AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Research & Development, LLC, Kadmon, LEO Pharma, Novartis, Pfizer and ViDac, 2; I. Gilloteau, Novartis Pharma AG, 3; T. Fox, Novartis Pharma AG, 1,Novartis Pharma AG, 3; J. Oliver, Novartis Pharma AG, 3; S. Jugl, Novartis Pharma AG, 1,Novartis Pharma AG, 3; A. B. Gottlieb, Amgen Inc, Astellas, Akros, Centocot Janssen), Inc; Celgene Corp, Bristol Myers Squibb Co, Beiersdorf Inc, Abbott Labs Abbvie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dempipsor Ltd., Incyle, Pfizer, Canfite, Eli Lilly and Company, Coronado, Vertex,, 5,Janssen Incyte, 2.

To cite this abstract in AMA style:

Mease PJ, Lebwohl M, Gilloteau I, Fox T, Oliver J, Jugl S, Gottlieb AB. 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 [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/secukinumab-treatment-of-psoriatic-arthritis-and-moderate-to-severe-psoriasis-relieves-anxietydepression-up-to-52-weeks-an-overview-from-secukinumab-phase-3-clinical-trials/. Accessed .
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