Phase 3 studies show upadacitinib is safe in the treatment of moderate-to-severe cases of eczema.
More than 2700 adults and adolescents were tested last year to reassure upadacitinb (Rinvoq; AbbVie) is safe in the treatment of moderate-to-severe cases of atopic dermatitis (AD). UPA is a selective reversible Janus kinase (JAK) inhibitor with established efficacy from previous AD treatment studies2. This study shows the JAK inhibitors are well tolerated, and no new safety risks have been found.
To conduct the study, adults and adolescents with moderate-to-severe AD were randomized into three groups to receive either oral UPA 15 mg, UPA 30 mg, or a placebo once daily over a span of 16 weeks. At week 16, study participants receiving the placebo were randomized to receive either oral UPA 15 mg or 30 mg. Baseline demographics and disease characteristics were similar across all treatment groups. A majority of the study participants had also participated in earlier phase studies and tolerated UPA well for one year. Researchers kept in touch with patients to assess longer-term safety until November 24, 2020.
Adverse effects affected all 3 study groups. Phase 3’s 16-week analysis showed more adverse effects for patients, especially those over the age of 65, taking the 30 mg of UPA compared to those with a placebo. However, rates of serious adverse effects were more common with those taking the placebo. Serious adverse effects with the placebo included nasopharyngitis, upper respiratory tract infection, headache, blood creatine phosphokinase increase, and oral herpes. Serious adverse effects with the UPA were infrequent but did happen with serious infections, pneumonia, and coronavirus being the most common. Each patient who had a serious adverse effect was examined and potentially had other health risk factors leading to serious adverse effects they experienced.
Acne was the most common treatment-emergent adverse effect researchers found in the phase three studies. Most of these cases were among adolescents and adults under the age of 40. Nearly all acne cases were on the face with inflammatory papules, pustules, and comedones.
While a few had to discontinue the study, many participants were able to continue and see an improvement in their AD. Primary reasons for study discontinuation included adverse events, withdrawn consent, follow-up, lack of efficacy, worsening symptoms, and systemic rescues. The study group with the most discontinued treatment cases was the placebo group, where 116 of the 902 participants discontinued the study.
Overall, the study shows 15-30 mg doses of UPA demonstrate superior efficacy in the treatment of moderate-to-severe AD. Researchers are pleased to recommend its use to help eczema patients as young as 12 and weighing more than 88.2 pounds.
1. Eczema Resource Center. American Academy of Dermatology. https://www.aad.org/public/diseases/eczema. Accessed November 27, 2022.
2. Guttman-Yassky E, Thyssen JP, Silverberg JI, et al. Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. Journal of Allergy and Clinical Immunology. 2022. doi:10.1016/j.jaci.2022.09.023