Study data published in Arthritis Care & Research suggest that the safety profile of ixekizumab in the treatment of psoriatic arthritis (PsA) is similar to the safety profile observed with ixekizumab for the treatment of plaque psoriasis and presents no unexpected health risks.
Researchers extracted existing safety data from the SPIRIT studies (ClinicalTrials.gov identifiers: NCT01695239, NCT02349295, and NCT02584855). Specifically, adverse event frequencies were assessed for the 24-week placebo-controlled period of SPIRIT-P1 and SPIRIT-P2 and for all ixekizumab-treated patients from SPIRIT-P1, SPIRIT-P2, and the SPIRIT-P3 open-label period. A total of 1118 patients received ixekizumab during SPIRIT for 1373.4 patient-years of total ixekizumab exposure.
During the placebo-controlled period, the frequency of treatment-emergent adverse events and serious adverse events was 68.1% and 4.4%, respectively, for patients treated with ixekizumab. For patients treated with placebo, these rates were reduced to 56.7% and 2.7%, respectively. Injection site reactions were present in 21.4% of ixekizumab-treated patients, compared with just 4.5% of placebo-treated patients. However, the incidence of injection-site reactions decreased with increasing ixekizumab exposure over the 96-week study period. Additional adverse events included infections (32.8% for ixekizumab vs 27.7% for placebo), serious infections (1.3% vs 0%), Candida sp infections (2.6% vs 0.4%), and nonanaphylactic hypersensitivities (5.3% vs 1.8%). No unexpected adverse events were reported.
Reported adverse events during the SPIRIT trial were consistent with those reported in existing data on the safety of ixekizumab for the treatment of plaque psoriasis. These results may be useful for clinicians in assessing the appropriate treatment course for patients with PsA.
This study was supported by Eli Lilly and Company.
Mease P, Roussou E, Burmester G-R, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials [published online August 29, 2018]. Arthritis Care Res. doi: 10.1002/acr.23738