Ixekizumab demonstrates no new safety concerns over 3 years in axial spondyloarthritis
Click Here to Manage Email Alerts
An analysis of long-term ixekizumab use over 3 years in patients with axial spondyloarthritis found no new safety signals, according to data published in The Journal of Rheumatology.
“The safety profile of [ixekizumab (IXE)] in patients with [axial SpA (axSpA)] has also been previously described, with no new safety signals reported through 2 years,” Atul Deodhar, MD, MRCP, of Oregon Health & Science University, and colleagues wrote. “Determining the safety profile of a biologic from multiple studies and long-term extension studies is of the utmost importance for patients receiving longstanding treatment.”
To investigate the long-term safety signals of ixekizumab (Taltz, Eli Lilly & Co.) in patients with axial SpA, Deodhar and colleagues reported data across 3 years of the COAST program, including 1 year from the originating studies — COAST-V, -W and -X — as well as 2 years from COAST-Y. Both COAST-V and COAST-Y investigated ixekizumab in patients with radiographic axial SpA. While COAST-X analyzed the drug in patients with non-radiographic axial SpA. The researchers evaluated data from patients who received at least one dose of ixekizumab during the COAST studies.
According to the researchers, a treatment withdrawal period began at week 76 of the COAST program depending on whether patients achieved remission using ixekizumab. Patients who previously achieved remission were randomized to continue receiving ixekizumab or go through treatment withdrawal. Patients who participated in the original COAST trials but did not achieve remission received uninterrupted ixekizumab.
The researchers analyzed safety outcomes through 156 weeks of therapy. Outcomes of interest included treatment-emergent adverse events, death, adverse events leading to therapy cessation and serious adverse events. Secondary efficacy outcomes include the percentage of patients who achieved 20% or 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS20/40) as well as the rate of patients who were able to achieve partial remission.
The analysis included a total of 932 patients. Over 3 years, treatment-emergent adverse events occurred at a rate of 38 per 100 patient-years, according to the researchers. The most common events were infections — 25.7 per 100 patient-years — and injection site reactions — 7.4 per 100 patient years. Generally, treatment-emergent adverse events were classified as “mild” or “moderate,” the researchers wrote. In addition, patients who received sustained therapy demonstrated improved disease symptoms.
“Here, we report that through 3 years of the COAST program, the safety profile is consistent with what has been previously published for IXE with up to 2 years of exposure,” Deodhar and colleagues wrote. “There were no new or unexpected safety concerns through 3 years of COAST.”
Collapse
Read more about
Click Here to Manage Email Alerts