What Upadacitinib Could Mean for Younger Patients With Severe Alopecia Areata

As the US Food and Drug Administration (FDA) reviews AbbVie’s supplemental new drug application for upadacitinib (Rinvoq) in severe alopecia areata, Natasha Mesinkovska, MD, PhD, highlighted the potential impact that an additional approved therapy could have on younger patients, long-term disease management, and broader recognition of alopecia areata as a chronic autoimmune condition.1,2

Speaking with the HCPLive team, Mesinkovska emphasized the unique burden alopecia areata can place on adolescents and their families. She noted that while some young patients may appear outwardly resilient, the psychosocial impact of hair loss during adolescence is often substantial. Based on her experience treating patients and participating in clinical trials, she suggested that successful treatment can have meaningful effects beyond hair regrowth alone, improving confidence and quality of life during a particularly vulnerable stage of development.

The inclusion of adolescents aged 12 years and older in the UP-AA phase 3 program was therefore a notable aspect of the submission, particularly given the limited number of approved treatment options currently available for younger patients with severe disease.

Mesinkovska also addressed the significance of complete scalp hair regrowth, one of the secondary endpoints achieved in the clinical program. She noted that expectations for treatment success in alopecia areata have evolved considerably in recent years. Historically, clinical trial responders were defined as patients achieving at least 80% scalp hair coverage, a benchmark that was itself considered highly meaningful. However, newer therapies are now raising expectations by demonstrating the possibility of near-complete or complete regrowth in some patients.

According to Mesinkovska, these outcomes help establish a higher standard for future therapies and reflect growing ambitions among both clinicians and patients seeking optimal disease control.

Despite recent advances, she noted that several important unmet needs remain. The underlying cause of alopecia areata is still not fully understood, limiting the ability to predict who will develop the disease or how it might be prevented. Additionally, disease flares can still occur even among patients receiving treatment, highlighting the need for therapies that provide durable long-term control.

Mesinkovska also pointed to the ongoing need for treatment strategies patients and clinicians can feel comfortable using over extended periods. While safety data for JAK inhibitors in alopecia areata have thus far been reassuring, she noted that the field continues to seek approaches that minimize treatment burden while maintaining efficacy.

Looking ahead, Mesinkovska noted a potential approval of upadacitinib could further reinforce understanding of alopecia areata as a chronic autoimmune disease rather than a purely cosmetic condition. Given the drug’s established use across multiple inflammatory diseases, she highlighted its potential expansion into alopecia areata may help underscore the immunologic nature of the disorder and its broader impact on patient health.

Disclosures: Mesinkovska has served on advisory boards for Arena Pharmaceuticals, Concert Pharmaceuticals, La Roche-Posay Laboratorie Pharmaceutique, Lilly ICOS LLC, Nutrafol, and Pfizer Inc.; as a speaker for Eli Lilly; and as an investigator for AbbVie, Arcutis, Inc., Arena Pharmaceuticals, Kyowa Hakko Kirin Pharma, Inc., Lilly ICOS LLC, Merz Aesthetics, and Pfizer Inc. She received honoraria for advisory board and speaking activities, research funding from Merz Aesthetics and Pfizer Inc., and no compensation for investigator roles with AbbVie, Arcutis, Arena Pharmaceuticals, Kyowa Hakko Kirin Pharma, and Lilly ICOS LLC.

References

1. AbbVie. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. Published April 28, 2026. Accessed June 9, 2026. https://www.prnewswire.com/news-releases/abbvie-submits-application-to-fda-for-upadacitinib-rinvoq-for-adults-and-adolescents-with-severe-alopecia-areata-302754816.html.

2. Smith T. Upadacitinib sNDA Submitted to FDA for Severe Alopecia Areata. HCPLive. April 28, 2026. Accessed June 9, 2026. https://www.hcplive.com/view/upadacitinib-snda-submitted-to-fda-for-severe-alopecia-areata.