Upadacitinib effective, mostly safe up to 76 weeks for adolescents with atopic dermatitis
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Key takeaways:
- By week 76, over 82% of patients treated with 15 mg or 30 mg of upadacitinib reached EASI 75.
- Upadacitinib maintained a safety profile consistent with previous studies.
Upadacitinib exhibited efficacy and a favorable benefit-risk profile for the long-term treatment of moderate to severe atopic dermatitis in adolescents, according to a study.
“Upadacitinib is a very exciting Janus kinase (JAK) 1 selective inhibitor that looks to be about as effective as anything we have for treating atopic dermatitis,” Amy S. Paller, MD, MS, Walter J. Hamlin Professor and Chair of Dermatology, professor of pediatrics and director of the Skin Biology and Diseases Resource-based Center at Northwestern University’s Feinberg School of Medicine, told Healio. “But the big concern has been, is efficacy maintained over time and, very importantly, what is the safety?”
The ongoing double-blind, placebo-controlled, randomized phase 3 Measure Up 1, Measure Up 2 and AD Up clinical trials have shown that upadacitinib (Rinvoq, AbbVie) is efficacious for adults and adolescents with AD through 52 weeks. In the current study, Paller and colleagues evaluated the efficacy and adverse events of upadacitinib in adolescent patients with moderate to severe AD through 76 weeks.
A total of 542 adolescents from the three previously mentioned ongoing studies were randomly assigned 1:1:1 to receive oral upadacitinib 15 mg or 30 mg or placebo daily for 16 weeks. At the end of week 16, placebo patients were again randomly assigned to receive one of the upadacitinib doses, whereas those originally on upadacitinib continued their dose. While most patients took upadacitinib or placebo alone, those from the AD Up trial also used topical corticosteroids.
Results showed that by week 76, EASI 75 was achieved by 89.1%, 84.4% and 87.8% of patients taking upadacitinib 15 mg from Measure Up 1, Measure Up 2 and AD Up, respectively. EASI 75 was also achieved by 96.1%, 93.6% and 82.7% of adolescents taking upadacitinib 30 mg in the respective studies.
The authors also found that the proportion of patients who continued or switched to upadacitinib achieving a validated IGA-AD score of 0 or 1 along with a worst pruritus-numeric rating scale improvement of at least 4 points either remained the same or increased through week 76.
Upadacitinib was generally safe and well tolerated, which was consistent with previous studies. The long-term exposure was not associated with an increase of adverse events, according to the investigator’s observations.
A total of 213.4, 215.5 and 246 treatment-emergent adverse events per 100 patient-years was observed in the Measure Up 1, Measure Up 2 and AD Up studies, respectively.
In the respective studies, 4, 7.5 and 5.4 serious adverse events occurred per 100 patient-years. Of note, 4, 1.9 and 1.1 events of herpetic infection and 11.6, 11 and 7.1 events of creatine kinase elevation were reported per 100 patient-years.
“The good news is that the medication continues to show evidence of efficacy in this patient population, and there really were no new signals that came out from this research to suggest that we have a concern,” Paller told Healio. “But we are not using these agents for most of our adolescents as the first line.”
According to Paller, there are other biologics that are incredibly safe and equally effective, however, not every patient responds adequately to these treatments.
“Having this kind of safety information can reassure us when we will transfer somebody to one of these medications,” Paller told Healio. “Then perhaps, over time, as we accrue more and more safety data, we will be able to consider whether this treatment would be first line for not just certain patients, but for even more patients.”