ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1347

Ixekizumab Efficacy in Patients with Psoriatic Arthritis Presenting with Symptoms Indicative of Axial Involvement

Atul Deodhar1, Dafna Gladman2, Rebecca Bolce3, David Sandoval3, So Young Park3, Soyi Liu-Leage4, Peter Nash5 and Denis Poddubnyy6, 1Oregon Health & Science University, Portland, OR, 2Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 3Eli Lilly and Company, Indianapolis, IN, 4Eli Lilly and Company, Neuilly sur Seine, France, 5Griffith University, Brisbane, Australia, 6Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany

Meeting: ACR Convergence 2021

Keywords: , , ,

Session Information

Date: Monday, November 8, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster II: Psoriatic Arthritis I (1329–1363)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Many patients with psoriatic arthritis (PsA) experience back pain and stiffness indicative of axial involvement [1]. The prevalence of axial involvement varies between 25-70% [2]. Ixekizumab (IXE), a monoclonal antibody with high affinity for IL17-A, has been studied in Phase 3 trials in patients with PsA (SPIRIT-P1 [Biologic-naïve; NCT01695239] and SPIRIT-P2 [Inadequate response or intolerant to 1 or 2 TNF inhibitors (TNFi); NCT02349295]) [3] [4]. The objective of this analysis was to determine the efficacy of IXE up to 52 weeks (Wks) in reducing axial symptoms and improving quality of life in patients with active PsA presenting with symptoms indicative of axial involvement.

Methods: This post-hoc analysis included data from two subpopulations of patients with PsA (pooled SPIRIT-P1 and -P2). Symptoms indicative of axial involvement were defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 (back pain) ≥4, and an average of Q5 + Q6 (intensity and duration of morning stiffness in the spine) ≥4 at baseline. Patients included in the sensitivity analysis subgroup 1 were, in addition to the above-mentioned criteria, < 45 years of age, while patients included in sensitivity analysis subgroup 2 were aged < 45 but had also elevated C-reactive protein (CRP) ( > 5 mg/l) at baseline. Efficacy of IXE was analysed using BASDAI questions, total BASDAI, mBASDAI (without Q3), and Ankylosing Spondylitis Disease Activity Score (ASDAS) change from baseline, as well as BASDAI50 response and Short-Form-36 physical component summary (SF-36 PCS) improvement, at Wks 16, 24 and 52. Treatment comparison was done using logistic regression for BASDAI50, and analysis of covariance (ANCOVA) model for other endpoints. Missing data for binary and continuous endpoints were imputed by non-responder imputation and modified baseline carried forward (mBOCF), respectively.

Results: A total of 313 patients (placebo (PBO), N=151; IXE Q4W, N=162) met the overall analysis inclusion criteria. Baseline values for BASDAI and ASDAS related endpoints were balanced across treatment arms (Table). Improvement in axial symptoms were significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Figure). Improvement in quality of life (QoL) measures (SF-36 PCS) were also significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Table). Similar results were observed for patients < 45 years, and in patients < 45 years with CRP > 5 mg/l at baseline (sensitivity analysis, data not shown).

Conclusion: IXE is effective in reducing axial symptoms and improving QoL in patients with active PsA presenting with symptoms indicative of axial involvement.

References

1. Yap KS. Ann Rheum Dis. 2018;77(11)

2. Feld J. Nat Rev Rheumatol. 2018;14

3. Orbai A. Clin Exp Rheumatol. 2020[online]

4. Genovese MC. Rheumatol. 2018;57(11)

Table. Baseline values and change from baseline (mBOCF) in the overall analysis population at Wks 16, 24 and 52 for BASDAI and ASDAS related endpoints in patients with PsA and axial pain. Data presented as mean (SD) unless otherwise specified. ‡p < 0.001 vs PBO.

Figure. Change from baseline (mBOCF) in BASDAI and ASDAS related endpoints in patients with PsA and axial pain in the overall analysis population. Data presented as mean (SD). ‡p < 0.001 vs PBO.

Disclosures: A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2; D. Gladman, AbbVie, 2, 5, Amgen, 2, 5, Eli Lilly, 2, 5, Galapagos, 2, 5, Gilead, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, Celgene, 2, 5, Bristol Myers Squibb, 2, 5; R. Bolce, Eli Lilly and Company, 3, 11; D. Sandoval, Eli Lilly and Company, 3, 11; S. Park, Eli Lilly and Company, 3, 11; S. Liu-Leage, Eli Lilly and Company, 3, 11; P. Nash, Janssen, 2, 5, 6, AbbVie, 2, 5, 6, Pfizer, 2, 5, 6, Novartis, 2, 5, 6, Eli Lilly, 2, 5, 6, Roche, 2, 5, 6, Bristol-Myers Squibb, 2, 5, 6, Sanofi, 2, 5, 6, Merck, 2, 5, 6, UCB, 2, 5, 6, Gilead/Galapagos, 2, 5, 6, Celgene, 2, 5, 6, Samsung, 2, 5, 6; D. Poddubnyy, AbbVie, 2, 5, 6, Eli Lilly and Company, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB, 2, 6, BMS, 2, 6, Roche, 2, 6.

To cite this abstract in AMA style:

Deodhar A, Gladman D, Bolce R, Sandoval D, Park S, Liu-Leage S, Nash P, Poddubnyy D. Ixekizumab Efficacy in Patients with Psoriatic Arthritis Presenting with Symptoms Indicative of Axial Involvement [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/ixekizumab-efficacy-in-patients-with-psoriatic-arthritis-presenting-with-symptoms-indicative-of-axial-involvement/. Accessed October 20, 2021.

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