The following article is a part of conference coverage from the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. The team at MPR will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the 2019 ACR/ARP Annual Meeting.
Ixekizumab demonstrated superiority to adalimumab in achieving simultaneous joint and skin improvement in biologic-naive patients with active psoriatic arthritis (PsA), according to 52 week data from the phase 3b/4 SPIRIT Head-to-Head (H2H) study presented at the 2019 American College of Rheumatology /Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019 in Atlanta, Georgia.
The SPIRIT-H2H trial (N=566) randomized PsA patients to receive ixekizumab (160mg starting dose followed by 80mg every 4 weeks) or adalimumab (40mg every 2 weeks) for 52 weeks; patients with moderate-to-severe plaque psoriasis received the approved dose of ixekizumab or adalimumab for that indication. The primary end point was simultaneous achievement of ≥50% reduction in disease activity, as defined by the American College of Rheumatology (ACR50), as well as complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI100) at week 24. Key secondary end points included the percentage of patients achieving ACR50, ACR70, and PASI100 at week 52
Results showed that ixekizumab was was found to be superior to adalimumab in improving PsA, meeting the primary end point at week 24. Findings at Week 52 showed ixekizumab achieved all key secondary end points as well, when compared with adalimumab:
- ACR50: 50% vs 50%, respectively
- ACR70: 35% vs 34%, respectively
- PASI100: 64% vs 41%, respectively
Additionally, a greater proportion of patients achieved simultaneous ACR50 and PASI100 at week 52 with ixekizumab (39%) compared with adalimumab (26%), regardless of concomitant methotrexate (MTX) use.
The safety profile of ixekizumab was consistent with that observed in previous studies. The most common adverse reactions for ixekizumab compared with adalimumab included infections (42% vs 39.2%), injection site reactions (10.6% vs 3.5%), allergic/hypersensitivity reactions (3.9% vs 4.6%), cytopenias (3.2% vs 4.2%), and cerebrocardiovascular events (1.8% vs 2.5%), respectively.
“The 24-week data from the SPIRIT-H2H trial demonstrated that ixekizumab, when compared to adalimumab, provided superior efficacy on the pre-specified combined end point of improvement in joint and skin symptoms. Ixekizumab had similar efficacy on the joint manifestations of the disease with better efficacy on the skin. The 52-week data show those results were consistent over time, regardless of concomitant methotrexate use,” said Josef Smolen, MD, professor of medicine at the Medical University of Vienna, Austria and lead author of the abstract.
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Smolen J, Nash P, Tahir H. 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. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract L20.