Upadacitinib Meets Endpoints in Phase 2b Study for Atopic Dermatitis

The study showed positive results for the drug and no new safety signals.

AbbVie has released positive top-line results from the phase 2b study of upadacitinib (ABT-494) for the treatment of atopic dermatitis.

The randomized, placebo-controlled, dose-ranging study investigated the drug for its potential as a once-daily oral JAK1-selective inhibitor in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.

The announcement follows a June 7 statement from AbbVie, in which the global pharmaceutical company posted strong phase 3 results for upadacitinib as a treatment for moderate to severe rheumatoid arthritis.

“We are excited by the results of this study, which show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “We look forward to advancing upadacitinib to Phase 3 studies in 2018. AbbVie’s continued progress across our upadacitinib clinical development program further demonstrates that selective inhibition of the JAK1 pathway may be a novel therapeutic approach across a broad range of immune-mediated diseases.”

The study’s primary endpoint was a mean percent change in the Eczema Area and Severity Index (EASI) score at 16 weeks compared to placebo. Secondary endpoints included a proportion of the patients achieving EASI 90, EASI 75, an Investigator Global Assessment (IGA) of 0 or 1 and a percent change in the pruritus/itch rating scale from baseline day 1 to week 16 compared to placebo.

All upadacitinib dose groups — 30/15/7.5 mg once daily — met the primary endpoint of a percent change from the baseline in EASI versus the placebo at 16 weeks. Results at week 16 showed across that primary and second endpoints across all doses improved significantly. Within the first week, reduction in itch was observed and within the first 2 weeks improvement in the skin occurred. The study showed positive results for the drug and no new safety signals.

The mean percent change from baseline in the EASI score, a measure of the extent and severity of atopic dermatitis and the primary endpoint in this study, was 74/62/39 percent for patients receiving the 30/15/7.5 mg doses of upadacitinib, respectively, compared to 23 percent for patients receiving placebo (p<0.001/0.001/0.05, respectively).

Clear or mostly clear skin was achieved by 50/31/14% of patients receiving the 30/15/7.5 mg doses, measured by the IGA scale, compared to 2% of patients receiving placebo. Significant improvement was observed in the pruritus/itch rating scale, as patients treated with upadacitinib experienced 69/48/40% improvement across the 30/15/7.5 mg doses measured by the pruritus numerical rating scale (NRS) compared to 10% of patients receiving the placebo.

The most common adverse effects across the treatment groups occurred in 2/1/0 patients in the 7.5/15/30 mg groups compared to 1 patient in the placebo group. Herpes zoster, malignancies, deaths or cases of pulmonary embolism (PE) or deep vein thrombosis (DVT) did not occur in this study. The safety profile in the patient population of upadacitinib will be further evaluated in phase 3.

Upadacitinib is not yet approved by regulatory authorities, and safety and efficacy are not yet established.

Phase 3 trials of upadacitinib in rheumatoid arthritis and psoriatic arthritis are ongoing. AbbVie plans to continue testing the drug’s potential to treat conditions like Crohn’s disease, ulcerative colitis and ankylosing spondylitis.

A press release regarding the study was made available.

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