Efficacy And Safety Of Secukinumab In Patients With Rotator Cuff Tendinopathy: A 24-Week, Randomised, Double-Blind, Placebo-Controlled, Phase Ii Proof-Of-Concept Trial

Background: Rotator cuff tendinopathy (RC TP) is a multifactorial condition and one of the most common causes of musculoskeletal burden. Current standard of care (SoC) is limited to pain relief with NSAIDs and physiotherapy. Recent evidence indicates that IL-17A-expressing tendon-resident immune cells are present in human overuse tendinopathy, and IL-17A levels are increased in early human tendinopathic tissue samples [1, 2]. Secukinumab (SEC) is a fully human, monoclonal antibody that binds to and neutralises IL-17A. Objectives: To evaluate the efficacy and safety of SEC in patients with active overuse RC TP refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections. Methods: 96 patients with symptomatic RC TP with no or Results: Clinically relevant improvement in both SEC and PBO groups on top of SoC treatment was observed, with no statistically significant difference demonstrated in the full study population on physical symptoms and function (Table 1). Similar results were observed in the secondary endpoints with marked improvement in both groups over time. Exploratory post-hoc analyses in a subpopulation of 39% of the study subjects with non-acute, moderate to severe disease, SEC provided significant and clinically relevant improvements vs PBO through Week 24 in total WORC score (overall treatment difference: 19.2, p Conclusion: Although SEC did not demonstrate a significant benefit vs PBO in the overall patient population with active overuse RC TP, SEC did provide benefit in the subpopulation with non-acute, moderate to severe disease. Larger clinical trials of SEC in this area are warranted. References: [1]Millar NL, et al. Sci Rep. 2016;6:27149. [2]Millar NL, et al. Nat Rev Rheumatol.2017;13:110-122. Disclosure of Interests: Neal L Millar Grant/research support from: Honoraria or research funding from Novartis and Stryker, Iain McInnes Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, Linda Mindeholm Employee of: Employee of Novartis, Abdelkader Seroutou Employee of: Employee of Novartis, Jens Praestgaard Employee of: Employee of Novartis, Ursula Schramm Employee of: Employee of Novartis, Rafael Levitch Employee of: Employee of Novartis, Eckhard Weber Employee of: Employee of Novartis, Didier Laurent Employee of: Employee of Novartis, Jeffrey Rosen Consultant of: Research advisor for Novartis, Georg Schett Speakers bureau: Received speakers honoraria from Abbvie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, UCB, Ronenn Roubenoff Employee of: Employee of Novartis, Matthias Schieker Employee of: Employee of Novartis.