Despite typically being well-tolerated, neither 150 mg nor 300 mg of risankizumab was beneficial in treating atopic dermatitis patients.
Risankizumab is approved for treating moderate-to-severe psoriasis, active psoriatic arthritis, and moderate-to-severe active Crohn’s disease in adult patients. However, risankizumab is not effective for the treatment of atopic dermatitis, according to findings reported in a multicenter, randomized, double-blind, placebo-controlled phase 2 trial published in Dermatology and Therapy.
Risankizumab Is Not Better Than Placebo
As evaluated by the Validated Investigator Global Assessment for AD (vIGA-AD) scale, risankizumab did not produce a better response than the placebo. Neither the 150 mg nor 300 mg dose of risankizumab resulted in a statistically significant increase in the proportion of patients reaching Eczema Area and Severity Index (EASI) scores of 75 at week 16 compared to placebo (13.0% [–1.7 to 27.7%; P = 0.084] and 10.0% [–4.6 to 24.7%; P = 0.179], respectively).
Risankizumab Demonstrated Improvement In Itching
As measured by the Worst Pruritus Numeric Rating Scale (WP-NRS), a larger proportion of individuals taking risankizumab demonstrated improvement in itching at week 16 compared to placebo. The study reported that itching was improved in 13.6% of patients with WP-NRS reduction of ≥ 4 points from baseline at week 16 who were using risankizumab 150 mg and 15.2% in those who used risankizumab 300 mg. On the other hand, the placebo group did not show any improvement.
Risankizumab Was Well-Tolerated
Risankizumab was usually well-tolerated in periods A and B of the research. Most adverse events (AEs) were of mild-to-moderate intensity and did not result in drug discontinuation. In period A, investigators reported AEs in 24 (70.6%) patients on the placebo, in 38 (55.11%) patients who were on risankizumab 150 mg, and in 39 (56.5%) patients in the risankizumab 300 mg group. The most frequently reported AEs of risankizumab were worsening of AD, nasopharyngitis, and itching. During period A, no major AEs were observed with risankizumab. The most prevalent AEs in period B were worsening AD and nasopharyngitis. Five patients experienced serious AEs, including two cases of cellulitis. No significant adverse events caused the withdrawal of risankizumab.
Although risankizumab was usually well-tolerated, neither 150 mg nor 300 mg proved effective in AD patients.
Tyring, S. K., Rich, P., Tada, Y., Beeck, S., Messina, I., Liu, J., Huang, X., & Shumack, S. (2023). Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb), 13(2), 595-608. https://doi.org/10.1007/s13555-022-00876-x