Direct Comparison of Ixekizumab and Adalimumab in Patients with Psoriatic Arthritis
The final results of the direct comparison of ixekizumab and adalimumab in the therapy of biologic-naïve patients with psoriatic arthritis were presented at the annual conference of the American College of Rheumatology (ACR/ARP) in November 2019 in Atlanta.
Options for Targeted Treatment of Psoriatic Arthritis
In the therapy of psoriatic arthritis (PsA), we have several disease-modifying biological drugs (bDMARDs) available. However, there are not many clinical trials comparing their efficacy and safety. One of the recently completed studies is SPIRIT-H2H, whose preliminary results at mid-follow-up indicated the superiority of ixekizumab, a monoclonal antibody against interleukin 17A, over the tumor necrosis factor alpha (TNF-α) inhibitor adalimumab.
Methodology and Course of the SPIRIT-H2H Study
A total of 566 patients meeting the criteria for PsA diagnosis (CASPAR), who had at least 3 tender and swollen joints, psoriasis on at least 3% of the body surface, and were biologic-naïve, participated in the randomized open-label study. The condition for entering the study was an inadequate response to at least one conventional DMARD. Patients were randomly assigned in a 1:1 ratio to receive ixekizumab or adalimumab for 52 weeks, at a dosage according to the relevant summary of product characteristics (SPC).
The aim of the study was to assess the number of patients who achieved a 50% improvement according to the criteria of the American College of Rheumatology (ACR50) and simultaneously a 100% improvement in the Psoriasis Area and Severity Index (PASI100). Further monitored outcomes included achieving low disease activity or remission, improvement in nail psoriasis, and improvements in disability score and quality of life (HAQ-DI). The authors also performed an efficacy analysis in subgroups of patients depending on concurrent use of methotrexate.
Results
The study was completed by 87% of patients on ixekizumab and 84% of those on adalimumab. Treatment with ixekizumab led to a significantly greater response during the study (36% of patients achieved ACR50 concurrently with PASI100 at week 24; at week 52, it was 39% of patients versus 28% on adalimumab, respectively, and 26% of patients on adalimumab), regardless of current methotrexate use. In other parameters assessing musculoskeletal and skin symptoms of PsA, ixekizumab performed at least as well as adalimumab at week 52.
Adverse events during treatment were reported in 73.9% of patients on ixekizumab and 68.6% of patients on adalimumab, with 4.2% of patients on ixekizumab and 7.4% on adalimumab discontinuing treatment due to adverse events. The safety profile of both drugs was consistent with previous observations.
Conclusion
Ixekizumab provided significantly greater improvements in both joint and skin symptoms in biologic-naïve PsA patients compared to adalimumab, from the 8th week of treatment through to the end of the one-year follow-up.
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Source: Smolen J., Nash P., Tahir H. et al. A head-to-head comparison of ixekizumab and adalimumab in biologic-naïve patients with active psoriatic arthritis: efficacy and safety outcomes from a randomized, open-label, blinded assessor study through 52 weeks. Arthritis Rheumatol 2019; 71 (suppl. 10): abstract n. L20.
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