Ixekizumab Demonstrates Tolerability and Safety Profile Consistent With Known Safety Profile in PsA

Ixekizumab has demonstrated safety and tolerability consistent with previous results among individuals with psoriatic arthritis (PsA), according to study results published in Annals of the Rheumatic Diseases.

The aim of the study was to study the long-term safety profile of interleukin (IL)-17A inhibitor ixekizumab among patients with PsA.

The integrated safety analysis included 4 randomized controlled clinical trials (ClinicalTrials.gov Identifiers: NCT01695239, NCT02349295, NCT02584855, and NCT03151551) with patients with PsA who received at least 1 dose of ixekizumab.

Adverse events (AEs) and treatment-emergent adverse events (TEAEs) were reported in exposure-adjusted incidence rates (EAIRs) per 100 person-years.

A total of 1401 patients with active PsA (mean age, 49.1 years; 51.5% women; 91.3% White; mean symptom duration, 9.4±8.6 years), representing a total of 2247.7 person-years of cumulative ixekizumab exposure over a period of 3 years, were included in the analysis.

The EAIR of patients with at least 1 TEAE was 80.7% (50.3 per 100 person-years), with serious AEs recorded among 9.6% (n=134) of the study population (0.4% resulted in deaths).

Nasopharyngitis (EAIR, 9.0%; 95% CI, 7.8%-10.3%), upper respiratory tract infection (EAIR, 8.3%; 95% CI, 7.2%-9.6%), and injection site reactions (EAIR, 6.9%; 95% CI, 5.9%-8.1%) were the most common TEAEs. Serious infections constituted an EAIR of 1.2% (95% CI, 0.9%-1.8%), malignancies 0.7% (95% CI, 0.4%-1.1%), inflammatory bowel disease 0.1% (95% CI, 0.0%-0.4%), depression 1.6% (95% CI, 1.2%-2.3%), and major adverse cerebrocardiovascular events 0.5% (95% CI, 0.3%-0.9%). Incidence rates remained constant or decreased over time.

Study limitations included the use of a different denominator compared with a recent meta-analysis (1000 vs 100 person-years, respectively), the limited cohort of participants, the lack of a long-term control group, and the potential lack of generalizability.

The study researchers concluded, “[T]he overall safety profile and tolerability of ixekizumab are consistent with the previously known safety profile in patients with PsA.” They also noted, “No new or unexpected safety events were detected.”

Disclosure: This clinical trial was supported by Eli Lilly & Company. Please see the original reference for a full list of authors’ disclosures.

Reference

Deodhar AA, Combe B, Accioly AP, et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Published online April 7, 2022. Ann Rheum Dis. doi:10.1136/annrheumdis-2021-222027