A recent study published in The Lancet Rheumatology has shown that ixekizumab is effective and well tolerated in children and adolescents with enthesitis-related arthritis and juvenile psoriatic arthritis. At 16 weeks, 90% of biologic DMARD-naive patients and 86% of biologic DMARD-experienced patients achieved a Juvenile Idiopathic Arthritis-American College of Rheumatology 30 (JIA-ACR30) response.
Enthesitis-related arthritis and juvenile psoriatic arthritis are subtypes of juvenile idiopathic arthritis that often present significant therapeutic challenges. Although treatment options such as non-steroidal anti-inflammatory drugs, glucocorticoids, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biologic DMARDs are available, many patients continue to experience inadequate disease control or fail to achieve sustained remission.
Ixekizumab is a humanized immunoglobulin G monoclonal antibody that selectively targets interleukin-17A (IL-17A), thereby inhibiting IL-17A-mediated inflammatory pathways. The drug is already approved by the U.S. Food and Drug Administration for adults with moderate-to-severe plaque psoriasis requiring systemic therapy or phototherapy, and previous studies have demonstrated its safety and efficacy in pediatric populations.
The multicenter phase 3 open-label trial enrolled 101 patients between April 2021 and April 2024. Eligible participants included children aged 6 to under 18 years with enthesitis-related arthritis and children aged 2 to under 18 years with juvenile psoriatic arthritis, provided they had at least three active peripheral joints and weighed at least 10 kg.The first 40 biologic DMARD-naive participants were randomized in a 1:1 ratio to receive either ixekizumab or adalimumab, while the remaining 61 participants received ixekizumab. Weight-based subcutaneous dosing was administered, with ixekizumab given at a starting dose of 40–160 mg followed by maintenance doses of 20–80 mg every four weeks. Adalimumab was administered at 20–40 mg every two weeks. The primary endpoint was the proportion of ixekizumab-treated patients achieving a JIA-ACR30 response at week 16.
Among the 81 participants treated with ixekizumab, 60 were biologic DMARD-naive and 21 had prior biologic DMARD exposure. The median age of participants was 14 years, 44% were female, and 85% were White.At week 16, 90% of biologic DMARD-naive participants achieved a JIA-ACR30 response, defined as at least 30% improvement in three of six core disease activity measures with no more than one measure worsening by over 30%. Similarly, 86% of biologic DMARD-experienced participants achieved the same response threshold.
Safety outcomes were encouraging. Most treatment-emergent adverse events in the ixekizumab group were mild or moderate, and no severe adverse events were reported. Investigators noted that the safety profile was consistent with previous findings in adult psoriatic arthritis, adult spondyloarthritis, and pediatric psoriasis studies. The findings suggest that ixekizumab may represent an important therapeutic option for children and adolescents with enthesitis-related arthritis and juvenile psoriatic arthritis who are candidates for biologic DMARD therapy, including those previously treated with biologic agents.
References
- Ramanan AV, Ruperto N, Foeldvari I, Vega-Cornejo G, Keller S, Wang R, et al. Ixekizumab in children with active psoriatic and enthesitis-related juvenile idiopathic arthritis (COSPIRIT-JIA): a multicentre, open-label, 16-week, Bayesian trial including a randomised reference group to adalimumab. Lancet Rheumatol. 2026 May;8(5):e377-e388.
- Preuss CV, Quick J. Ixekizumab. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 [cited 2026 May 23]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK431088/ PubMed PMID: 28613740.
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