Other Outcomes
Other secondary outcomes assessed in the study included the proportion of patients who achieved ASAS20 response at 16 weeks. Compared with placebo, more patients treated in the IXEQ2W and IXEQ4W treatment groups achieved an ASAS20 response at 16 weeks (29.8% vs. 46.9% and 48.2%, respectively).
In terms of safety, patients treated with either dose of ixekizumab experienced more treatment emergence adverse events compared to placebo, including Candida infections (n=2) and herpes zoster infection (n=1), as well as infections (n=2; one peritonitis and one pharyngitis). In addition, one patient suffered grade 2 neutropenia, and one patient was diagnosed with acute promyelocytic leukemia four weeks after treatment initiation.
“All these side effects are potentially worrisome,” says Muhammad Asim Khan, MD, a professor of medicine in the Division of Rheumatology at Case Western Reserve University School of Medicine, Cleveland. In addition to these side effects, Dr. Khan notes that treatment-emergent anti-drug antibodies were observed in about 6% of patients in the treatment groups compared with 3% of patients in the placebo group, and that acute anterior uveitis and inflammatory bowel disease were not prevented in the treatment groups.
While emphasizing that ixekizumab does provide another therapeutic option for patients with radiographic axial spondyloarthritis, and is the second IL-17 inhibitor after secukinumab, Dr. Khan also points to the percentage of patients who received ixekizumab and suffered injection site reactions (12.5% compared with 5.8% of placebo patients). “It is worth noting that the injection site reactions are comparatively very uncommon in patients treated with secukinumab,” he says.
For Dr. Deodhar, the results of the study point to the potential for ixekizumab to effectively and safely treat patients with axial spondyloarthritis.
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.
References
- Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534–2548.
- Pavelka K, Kivitz A, Dokoupilova E, et al. Efficacy, safety and tolerability of secukinumab in patients with active ankylosing spondylitis: A randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Therapy. 2017 Dec 22;19(1):285.
- Sieper J, Deodhar A, Marzo-Ortega H, et al. Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: Results from the MEASURE 2 Study. Ann Rheum Dis. 2017;76(3):571–592.
- Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: 16 week results of a phase 3 randomized, double-blind, placebo-controlled trial in patients with prior inadequate response or intolerance to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599–611.