AB0659 SECUKINUMAB PROVIDES SIGNIFICANT IMPROVEMENT OF SPINAL PAIN IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE 24-WEEK PHASE 3 SKIPPAIN STUDY
Authors: D. Poddubnyy, E. Pournara, A. Zielińska, A. Baranauskaite, A. Muñoz Jimenez., P. Kumari, B. Schulz, M. Rissler, C. Perella, H. Marzo-Ortega
Journal: Annals of the Rheumatic Diseases (2020)

Background: Spinal inflammation causing back pain is a hallmark of axial spondyloarthritis (axSpA) mainly affecting the sacroiliac joints and spine. 1 Spinal pain is the most burdensome symptom resulting in substantial functional limitations and impairment of health-related quality of life. Objectives: SKIPPAIN ( NCT03136861 ) evaluated efficacy and safety of secukinumab (SEC) in reducing spinal pain in patients (pts) with axSpA who had an inadequate response to NSAIDs. Methods: SKIPPAIN, a 24 week (wk), randomised, double-blind, multicentre trial, enrolled axSpA pts (aged ≥18 years) with active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 and average spinal pain numerical rating scale (NRS) score &gt;4 at baseline (BL) and inadequate response to ≥2 NSAIDs ≥4 wks. The trial had a PBO-controlled period from BL to Wk 8 and a SEC 150/300 mg period from Wk 8 to Wk 24. Primary and key secondary endpoints were superiority of SEC 150 mg compared to PBO in achieving average spinal pain score &lt;4 on a 0–10 NRS and BASDAI score &lt;4 at Wk 8, respectively. Results: 380 axSpA pts (269 (70.8%) AS and 111 (29.2%) nr-axSpA) were randomised to SEC 150 mg (N=285) or PBO (N=95). Demographic and BL characteristics are presented in Table 1 . Proportion of responders, in terms of average spinal pain, was 31.9% vs. 20.0% for SEC vs PBO (p&lt;0.05) and proportion of pts with BASDAI score of &lt;4 was 33.3% vs. 23.2% for SEC vs PBO (p&lt;0.05), respectively at Wk 8 ( Table 2 ). After Wk 8, responder rates increased with SEC treatment. No unexpected safety events were reported. Conclusion: Secukinumab provided significant improvement of spinal pain in pts with axSpA. SEC was well tolerated with a safety profile consistent with previous reports. 2 References: [1]Danve A &amp; Deodhar A. Clin Rheumatol . 2019;38:625-34. [2]Deodhar A, et al. Arthritis Res Ther . 2019;21(1):111. Table 1. Patient Demographics and BL Characteristics Characteristic SEC 150 mg N = 285 PBO N = 95 Age (years) 1 42.3 (11.9) 40.9 (12.2) Female 2 106 (37.2) 39 (41.1) Time since onset of back pain (years) 1 13.2 (10.1) 12.3 (9.6) HLA-B27 positive 2 233 (81.8) 76 (80.0) hsCRP (mg/L) 1 13.0 (21.5) 13.2 (23.5) Elevated hsCRP (&gt;5 mg/L) 2 140 (49.1) 49 (51.6) Previous exposure to TNF-α inhibitors 2 34 (11.9) 11 (11.6) Spinal pain NRS Score, 0-10 (average) 1 7.27 (1.37) 7.31 (1.31) Spinal pain NRS Score, 0-10 (nocturnal) 1 7.31 (1.42) 7.40 (1.35) Spinal pain NRS Score, 0-10 (total) 1 7.23 (1.51) 7.22 (1.48) BASDAI 1 7.09 (1.22) 6.91 (1.38) ASDAS 1 3.75 (0.89) 3.67 (0.84) Peripheral arthritis 2 104 (36.5) 30 (31.6) 1 mean (Standard Deviation), 2 n (%). hsCRP, high-sensitivity CRP; N, number of randomized pts; n, number of evaluable pts; NRS, numerical rating scale Table 2. Inferential Analysis of Achieving Spinal Pain and BASDAI Score &lt;4.0 Using Logistic Regression Model at Wk 8 Variable Treatment Group n/N (% ) Odds ratio versus PBO 95% CI P-value Spinal Pain NRS Score (Average ) SEC 150 mg 91/285 (31.9 ) 1.89 (1.08, 3.33) 0.0264 PBO 19/95 (20.0 ) Spinal Pain NRS Score (Nocturnal ) SEC 150 mg 77/285 (27.0 ) 1.72 (0.95, 3.10) 0.0720 PBO 17/95 (17.9 ) Spinal Pain NRS Score (Total ) SEC 150 mg 92/285 (32.3 ) 2.38 (1.31, 4.31) 0.0043 PBO 16/95 (16.8 ) BASDAI score SEC150 mg 95/285 (33.3 ) 1.75 (1.01, 3.04) 0.0466 PBO 22/95 (23.2 ) P-values are from a Logistic regression model with treatment as the principle factor and prior exposure to TNF inhibitors and naïve/inadequate responders to TNF inhibitors as stratification factors. Missing values were imputed as non-responders. N, Number of randomised pts; n, Number of pts who are responders/evaluable pts. Disclosure of Interests: Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Agnieszka Zielińska Consultant of: Novartis, Pfizer, Asta Baranauskaite Consultant of: AbbVie, Speakers bureau: Novartis, AbbVie, Amgen, Roche, KRKA, Alejandro Muñoz Jimenez.: None declared, Preeti Kumari Employee of: Novartis Healthcare Pvt. Ltd., Barbara Schulz Employee of: Novartis, Michael Rissler Shareholder of: Novartis, Employee of: Novartis, Chiara Perella Shareholder of: Novartis, Employee of: Novartis, Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB