Findings from a 12-week phase 2b study show significant improvement in the signs and symptoms of atopic dermatitis with once-daily treatment of an oral Janus kinase 1 selective inhibitor, abrocitinib 100 mg or 200 mg.
“The proportion of patients who achieved an Investigator’s Global Assessment of clear or almost clear with improvement of two grades or more from baseline peaked by weeks 4 to 6 for the 200 mg group but continued to improve through week 12 in the 100 mg group,” Melinda J. Gooderham, MD, medical director of the SKiN Centre for Dermatology in Ontario, Canada, and colleagues wrote.
A total of 267 adults participated whom had a diagnosis of moderate to severe atopic dermatitis for 1 year or more with an inadequate response or contraindication to topical medications. Of those, 157 patients completed the study. The researchers’ analysis included the full analysis set of 263 patients. Treatment discontinuation was more common in the 10 mg and 30 mg abrocitinib (Pfizer) groups and placebo group due to insufficient treatment responses and the use of prohibited medications.
Patients were randomly assigned to abrocitinib 10 mg, 30 mg, 100 mg or 200 mg, or placebo, once daily for 12 weeks.
The following patients achieved grades of clear or almost clear on the Investigator’s Global Assessment (IGA) scale at week 12 with improvement of two grades or more from baseline:
- 21 of 48 patients (43.8%) receiving 200 mg abrocitinib;
- 16 of 54 patients (29.6%) receiving 100 mg abrocitinib;
- four of 45 patients (8.9%) receiving 30 mg abrocitinib;
- five of 46 patients (10.9%) receiving 10 mg abrocitinib; and
- three of 52 patients (5.8%) receiving placebo.
Additionally, patients in the 100 mg and 200 mg dose groups achieved a significantly greater proportion of clear or almost clear on the IGA scale. However, differences in the IGA scale improvement between the 10 mg and 30 mg groups were not significant from placebo.
Eczema Area and Severity Index (EASI) reductions were 82.6% for those receiving 200 mg abrocitinib, 59% in those receiving 100 mg and 35.2% in the placebo group.
The researchers observed significant differences in percentage change in EASI as early as week 1 compared with placebo in the 200 mg group (–28.3%; P < .001) and at week 2 in the 100 mg group (–14.3%; P = .03).
Abrocitinib doses of more than 10 mg showed changes in platelet count. Maximum decreases in platelet count were apparent at week 4 in the 100 mg group at a maximum mean change of –11.4% and in the 200 mg group of –29.8%.
Gastrointestinal disorders were the only treatment-related adverse events to occur more frequently in those on abrocitinib than placebo, but the events were mild, according to researchers.
Phase 3 trials will further explore the efficacy and safety of 100 mg and 200 mg abrocitinib. – by Abigail Sutton
Disclosures: Gooderham reports she received grants, personal fees and/or nonfinancial support from AbbVie, Amgen, Akros, Arcutis, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, Kyowa Kirin, Leo Pharma, MedImmune, Merck, Novartis, Pfizer, Roche, Sanofi Genzyme, Regeneron, UCB and Valeant. Please see the study for all other authors’ financial disclosures.