Efficacy and safety of topical roflumilast in treating plaque psoriasis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
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Posted on September 28th, 2022
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Roflumilast is an anti-inflammatory agent that has been approved by the Food and Drug Administration in 2020 to treat chronic obstructive pulmonary disease. Its topical formulation had recently been approved for treating plaque psoriasis in July of 2022. The investigating team behind the trial had recently published their findings on the efficacy and safety of topical roflumilast.
The two phase 3 clinical trials included a total of 881 patients that had been suffering from plaque psoriasis for at least 6 months. Following a 2-to-1 randomization scheme, two-third of the study population was prescribed daily topical administration to the affected area of 0.3% roflumilast cream for 8 weeks, and the remaining received a placebo treatment. The 2 trials found that the roflumilast cream is 28.8%-37.5% more effective at reducing the presence of psoriasis plaque than the placebo - comparison was made using the Investigator Global Assessment (IGA) parameter. Using the Psoriasis Area and Severity Index (PASI) as a comparison parameter, we can see that 32.4%-36.1% more individuals in the roflumilast group have a 75% reduction from the baseline PASI score than the placebo group. In terms of side effects, 25.2%-25.9% of the roflumilast group report the presence of treatment-related adverse events; the percentage is 18.4%-25.9% for the placebo group. Some of the common side effects reported include diarrhea and headache.
The two phase 3 clinical trials included a total of 881 patients that had been suffering from plaque psoriasis for at least 6 months. Following a 2-to-1 randomization scheme, two-third of the study population was prescribed daily topical administration to the affected area of 0.3% roflumilast cream for 8 weeks, and the remaining received a placebo treatment. The 2 trials found that the roflumilast cream is 28.8%-37.5% more effective at reducing the presence of psoriasis plaque than the placebo - comparison was made using the Investigator Global Assessment (IGA) parameter. Using the Psoriasis Area and Severity Index (PASI) as a comparison parameter, we can see that 32.4%-36.1% more individuals in the roflumilast group have a 75% reduction from the baseline PASI score than the placebo group. In terms of side effects, 25.2%-25.9% of the roflumilast group report the presence of treatment-related adverse events; the percentage is 18.4%-25.9% for the placebo group. Some of the common side effects reported include diarrhea and headache.