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

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]).

• Authors: 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
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 50 Issue 8 Pg. 1020-1028 (08 2023) ISSN: 0315-162X [Print] Canada
• PMID: 36792107 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2023 by the Journal of Rheumatology.

Chemical References

• ixekizumab
• Dermatologic Agents

Topics

• Humans
• Treatment Outcome
• Double-Blind Method
• Dermatologic Agents (therapeutic use)
• Spondylitis, Ankylosing (drug therapy)