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In this Q&A, Gerd R. Burmester, MD, discussed the findings of his study that evaluated the exposure to ixekizumab, outcomes and medical history of patients with active psoriatic arthritis (PsA) who experienced adverse events.
In patients withactive psoriatic arthritis (PsA), the use of ixekizumab (Taltz, Eli Lilly) is safe for up to 3 years, according to an analysis of data from 4 clinical trials with over 2000 patient-years of exposure. The results, published in the Annals of the Rheumatic Diseases,1reinforce the known safety profile of ixekizumab in patients with active PsA.
In this Q&A, corresponding author Gerd R. Burmester, MD, professor of medicine and rheumatology at Charité – Universitätsmedizin Berlin, Germany, discussed the research and its findings.
Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin 17A (IL-17A), is approved for the treatment of active PsA. In this analysis, Burmester and colleagues reported the updated safety profile of ixekizumab for the PsA SPIRIT program. The analysis included 4 clinical trials with a total of 1401 patients with PsA who received at least one dose of ixekizumab, representing a cumulative ixekizumab exposure of 2247.7 patient-years. The mean age of patients was 49.1 years and 51.5% were female. Treatment-emergent adverse events (TEAEs), selected adverse events (AEs) and exposure-adjusted incidence rates (EAIRs) per 100 patient-years up to 3 years of exposure were reported.
Overall, TEAEs occurred in 80.7% (EAIR=50.3 per 100 patient-years) of patients and were mainly mild to moderate. The most common TEAEs were infections, including nasopharyngitis and upper respiratory tract infection, and injection site reactions. Serious AEs occurred in 9.6% (EAIR=6.0) of patients. The EAIRs of depression, major adverse cerebro-cardiovascular events malignancies and inflammatory bowel disease were low, at 1.6, 0.7, 0.5 and 0.1, respectively. The incidence rates decreased or were constant over time, with no new or unexpected safety events detected.
Rheumatology Network: Why was the study conducted?
Gerd R. Burmester, MD: IL-17A inhibition is a very important therapeutic option in the treatment of psoriatic arthritis. Ixekizumab is an approved drug to target IL-17. It is highly efficacious both regarding the improvement of joint involvement and skin manifestations. Therefore, it is important to know the safety profile of such a reagent. For these assessments, a high degree of exposure is very helpful.
Here, we could use data from 4 clinical trials with over 2000 patient-years of exposure and up to 3 years of follow up. In these carefully monitored trials, the quality of data is especially helpful.
RN: What were the surprises from the findings?
GB:The data are reassuring that no (unpleasant) surprises were found regarding the safety profile.
Notably, the EAIRs of malignancies, inflammatory bowel disease including ulcerative colitis and Crohn’s disease, depression and major adverse cerebro-cardiovascular events were low.
RN: How significant are the findings?
GB: The data are very important to assess the safety profile of an efficacious drug and to inform both patients and treating physicians.
RN: What is the current practice and how could the findings possibly change things?
GB: The data provide important information how to use this drug in our treatment repertoire, especially in patients with risk factors.
RN: What are the takeaway points for clinicians?
GB: Taken together, the overall safety profile and tolerability of ixekizumab in this very large study are consistent with the known safety profile in patients with PsA. No new or unexpected safety events were detected in a long observation period.
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 ahead of print, 2022 Apr 7]. Ann Rheum Dis. 2022;annrheumdis-2021-222027. doi:10.1136/annrheumdis-2021-222027