Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study
Bibliographic record
Abstract
OBJECTIVE: Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis. METHODS: Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily. RESULTS: Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported. CONCLUSION: Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".