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AbbVie Inc. has announced that its alopecia areata treatment, Rinvoq (upadacitinib), has successfully met the primary endpoints in two pivotal late-stage trials. The trials evaluated two dosage regimens: 15 milligrams and 30 milligrams per day. The results showed that after 24 weeks of treatment, 45.2% of patients in the 15 milligrams group achieved at least 80% scalp hair regrowth, while 55% in the 30 milligrams group reached the same milestone. In contrast, only 1.5% of patients in the placebo group experienced similar hair regrowth.
In addition to scalp hair regrowth, the trials also verified secondary efficacy endpoints, demonstrating significant improvements in eyebrow and eyelash growth. Some participants even achieved over 90% scalp hair coverage. These findings further support the potential of Rinvoq as a viable treatment option for alopecia areata.
Regarding safety, the incidence of adverse events in both dosage groups was consistent with the safety profile of Rinvoq's already approved indications. The 15 milligrams group had a 1.9% rate of serious adverse events, while the 30 milligrams group had a 1.8% rate, both slightly higher than the 0.7% rate observed in the placebo group. However, the overall risk remains within an acceptable range.
AbbVie emphasized that the trial results align closely with data from the UP-AA clinical project's initial parallel study, further validating Rinvoq's potential in the treatment of alopecia areata. The company is now advancing regulatory submissions for Rinvoq, aiming to provide a new treatment option for the millions of patients worldwide suffering from severe alopecia areata.

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