- King B. Top-line results from THRIVE-AA1: A clinical trial of CTP-543 (Deuruxolitinib), an oral JAK inhibitor, in adult patients with moderate to severe alopecia areata. D3T01.1L, EADV Congress 2022, Milan, Italy, 7–10 September.
THRIVE-AA1 (NCT04518995) is a multinational, phase 3 trial in adult patients with severe AA, aiming to assess the efficacy and safety of the novel JAK inhibitor deuruxolitinib with a study duration of up to 32 weeks1. Participants were treated with either 8 mg or 12 mg deuruxolitinib twice daily or placebo and had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT). The primary efficacy endpoint was the percentage of participants achieving a SALT score of ≤20 at week 24. “We also looked at patient satisfaction,” Prof. Brett King (Yale University School of Medicine, CT, USA) said. The percentage of responders, defined as “satisfied” or “very satisfied” on the Hair Satisfaction Patient Reported Outcome (SPRO) scale at week 24 was assessed as a key secondary outcome.
At baseline, participants had a mean SALT score of 88. At week 24, participants treated with both doses of deuruxolitinib achieved the primary endpoint: 42% in the 12 mg dose group and 30% in the 8 mg dose group, compared with 1% in the placebo group achieved a SALT score ≤20 (P<0.0001 vs placebo). “In AA, this is truly transformative, we see a very low placebo rate. In severe disease, the chance of spontaneous remission is close to 0,” Prof. King said. In the low dose and high dose groups, 21% and 35% respectively, achieved an even more stringent SALT score of ≤10 (P<0.0001 vs placebo).
Significant changes in SALT score were seen as early as 4 weeks. The agent also led to a significant improvement in eyebrow regrowth. “We wanted to know whether our impression aligns with what patients feel. Indeed, we see a high degree of patient satisfaction with scalp hair,” Prof. King said, with 42% responders in the low dose group and 52% responders in the high dose group.
Overall, the agent was generally well tolerated and more than 97% of participants will roll over into the open-label, long-term extension study.