Clinical Scorecard: Upadacitinib may improve scalp hair regrowth

At a Glance

Key Highlights

• Both trials met the primary endpoint: at week 24, 45% of patients receiving 15 mg and 54% to 55% receiving 30 mg achieved a SALT score of 20 or less, compared with 2% to 3% receiving placebo.
• Complete scalp hair regrowth at week 24 occurred in 13% to 14% of patients receiving 15 mg and 20% to 23% receiving 30 mg, versus 0% to 1% receiving placebo.
• Eyebrow and eyelash response rates, patient-reported disease improvement, and quality-of-life measures favored upadacitinib over placebo.
• Treatment-emergent adverse events occurred in 63% of patients receiving 15 mg, 67% receiving 30 mg, and 57% receiving placebo; no new safety signals were identified during 24 weeks.
• The 24-week observation period, exclusion criteria, predominantly White study population, and small adolescent subgroup limit conclusions about longer-term outcomes and generalizability.

Guideline-Based Recommendations

Diagnosis

• Trial eligibility required severe alopecia areata with a SALT score of at least 50, indicating at least 50% scalp hair loss.

Management

• Participants received once-daily oral upadacitinib 15 mg or 30 mg, or placebo, for 24 weeks.
• The study authors stated that the findings suggest upadacitinib may be an effective therapeutic option for adults and adolescents with severe alopecia areata.
• The trials did not formally compare the 15-mg and 30-mg doses.

Monitoring & Follow-up

• Study assessments included SALT scores, eyebrow and eyelash regrowth, patient-reported disease improvement, symptoms, daily-activity interference, and health-related quality of life.
• Longer-term follow-up is needed to evaluate response durability and safety beyond the 24-week treatment period.

Risks

• Common treatment-emergent adverse events included acne, nasopharyngitis, upper respiratory tract infections, and elevated blood creatine phosphokinase.
• Serious adverse events occurred in 2% of patients in each upadacitinib group and in less than 1% receiving placebo; no deaths were reported.
• The 24-week placebo-controlled period limits conclusions about longer-term efficacy and safety.

Patient & Prescribing Data

The two trials enrolled 1,399 patients, including 118 adolescents, aged 12 to under 64 years with severe alopecia areata and SALT scores of at least 50. Patients with a current episode lasting more than 8 years and those outside the study age range were excluded.

At week 24, SALT scores of 20 or less were achieved by 45% of patients receiving 15 mg and 54% to 55% receiving 30 mg, versus 2% to 3% receiving placebo. The 30-mg group had higher response rates than the 15-mg group for most endpoints, but formal dose comparisons were not conducted.

Clinical Best Practices

• Interpret the reported results in the context of the trial population: patients had severe disease, and those with episodes lasting more than 8 years were excluded.
• Consider that adolescent results came from a subgroup of 118 participants and may have limited precision.
• Do not infer long-term efficacy or safety from the 24-week treatment period.

Related Resources & Content

• JAMA Dermatology study of upadacitinib in severe alopecia areata (UP-AA1 and UP-AA2; citation details not provided in the article text)