Arcutis Reports Interim Results from the P-III (INTEGUMENT-OLE) Trial of Roflumilast for Mild to Moderate Atopic Dermatitis
Shots:
- The P-III long-term open-label study evaluating roflumilast (0.15%) in adults & children aged ≥6yrs. with AD. The results were found to be well-tolerated with durable & improved efficacy over time
- 46.1% & 51.0% of patients who had rolled over the treatment arm of the (INTEGUMENT-1 or -2) trials achieved vIGA-AD at 28 & 56wk. while 61.5% & 66.2% showed a 75% improvement from baseline in EASI-75 after 28 & 56wks., respectively.
- Participants switched to twice weekly dosing schedule & maintained disease control, safety & tolerability profile was consistent with short-term data in AD with no new safety signals @56wks., AEs led to treatment discontinuation in 3.0%. The company plans to submit the sNDA in Q3’2023 for roflumilast 0.15% in patients aged ≥6yrs.
Ref: Arcutis | Image: Arcutis
Related News:- Arcutis Entered into a Collaboration and License Agreement with Huadong for Roflumilast in Greater China and Southeast Asia
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