Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program

Atul Deodhar; Denis Poddubnyy; Proton Rahman; Jeorg Ermann; Tetsuya Tomita; Rebeca Bolce; Soyi Liu Leage; Andris Kronbergs; Caroline Johnson; Joana Araújo; Ann Leung; Désirée van der Heijde

doi:10.3899/jrheum.221022

Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program

J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.

Authors

Affiliations

¹ A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA; deodhara@ohsu.edu.
² D. Poddubnyy, MD, Rheumatology Department, Charité - Universitätsmedizin Berlin, Berlin, Germany. and German Rheumatism Research Centre, Berlin, Germany.
³ P. Rahman, MD, Department of Medicine, Memorial University of Newfoundland, Newfoundland and Labrador, Canada.
⁴ J. Ermann, MD, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁵ T. Tomita, MD, Department of Orthopedic Surgery, Osaka University Hospital, Osaka, Japan.
⁶ R. Bolce, MSN, S. Liu Leage, MD, A. Kronbergs, PhD, C. Johnson, MD, J. Araújo, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA.
⁷ A. Leung, MS, Syneos Health Inc., Morrisville, North Carolina, USA.
⁸ D. van der Heijde, MD, Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.

PMID: 36792107
DOI: 10.3899/jrheum.221022

Abstract

Objective: To report safety and efficacy of ixekizumab (IXE) from the COAST program at 3 years, including 1 year from the originating studies (COAST-V, COAST-W, and COAST-X), and 2 years from COAST-Y.

Methods: In COAST-Y, patients continued with the dose received at the end of the originating study at week 52: 80 mg IXE either every 4 weeks (Q4W) or every 2 weeks (Q2W). Placebo-treated patients from COAST-X received IXE Q4W in COAST-Y. Starting at week 116 (week 64 of COAST-Y), patients receiving IXE Q4W could be escalated to Q2W. Safety for patients receiving ≥ 1 dose of IXE and efficacy for patients receiving ≥ 1 dose of IXE Q4W was assessed. Data are summarized as observed.

Results: For the 932 patients who received ≥ 1 dose of IXE (Q2W or Q4W) through 3 years, treatment-emergent adverse events (TEAEs) occurred at an incidence rate (IR) of 38.0 per 100 patient-years (PYs). The most frequently reported were infections (IR 25.7 per 100 PYs) and injection site reactions (IR 7.4 per 100 PYs); the majority of TEAEs were mild or moderate in severity. In total, 7.1% of TEAEs led to discontinuation (IR 3.1 per 100 PYs). All patient groups receiving IXE Q4W assessed through 3 years saw sustained improvements in Ankylosing Spondylitis Disease Activity Score, clinically important improvement, and other efficacy end points.

Conclusion: The 3-year safety profile of IXE in the COAST program is consistent with the previously established long-term safety profile. IXE Q4W provided sustained improvement of disease activity in patients who received treatment through 3 years. (ClinicalTrials.gov: NCT02696785 [COAST-V], NCT02696798 [COAST-W], NCT02757352 [COAST-X], and NCT03129100 [COAST-Y]).

Keywords: biological therapy; clinical trials; disease activity; interleukins; spondyloarthropathy.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Dermatologic Agents* / therapeutic use
Double-Blind Method
Humans
Spondylitis, Ankylosing* / drug therapy
Treatment Outcome

Substances

ixekizumab
Dermatologic Agents

Associated data

ClinicalTrials.gov/NCT03129100
ClinicalTrials.gov/NCT02757352
ClinicalTrials.gov/NCT02696798
ClinicalTrials.gov/NCT02696785