What the trial was testing
The DERMIS enrolled 442 patients with psoriasis. The study was sponsored by Arcutis Biotherapeutics, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
40% of patients achieved clear or almost clear skin with roflumilast cream versus 6% with plain cream.
JAMA · 2022 · NCT04211389
These findings — that roflumilast cream cleared skin in 40% of patients versus 6% with plain cream — were published in the JAMA and represent the headline result of the study.
Researchers tracked outcomes across 442 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with psoriasis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Roflumilast cream is now FDA-approved for plaque psoriasis. It's applied once daily and showed strong results in clearing skin and reducing itching. Talk to your dermatologist about whether this treatment is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open psoriasis trials
The Norwegian Antirheumatic Drug Register
NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.