Deuruxolitinib achieves hair regrowth, even in patients with severe alopecia areata

In the phase 3 THRIVE-AA1 trial, the investigative JAK inhibitor deuruxolitinib led to remarkable hair regrowth in patients with severe alopecia areata (AA). Up to 42% of participants achieved the primary efficacy endpoint, e.g. a SALT score ≤20 at week 24, in many cases with a rapid onset of effect.  Patients were very satisfied with the treatment results.

Similar to baricitinib, which is already approved for AA in Europe and Japan, deuruxolitinib also targets JAK1 and JAK2. In the multinational, phase 3 THRIVE-AA1 trial (NCT04518995), adult patients with severe AA were included to assess the efficacy and safety of deuruxolitinib with a study duration of up to 32 weeks [1]. 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 the 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; see Figure). “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).

Figure: Proportion of patients achieving SALT score ≤20 at week 24 [1]



SALT, Severity of Alopecia Tool; BID, twice daily; *****, P<0.0001 vs placebo.

Significant changes in SALT score were seen as early as week 4. 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. According to Prof. King, this data is highly encouraging and supports the potential of deuruxolitinib to regrow hair on the scalp, eyebrows, and eyelashes in patients with AA.

1. 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.

Copyright ©2022 Medicom Medical Publishers



Posted on 5 November 202217 May 2024