Efficacy and safety of apremilast in paediatric patients with moderate-to-severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Oral treatment options for paediatric patients with moderate-to-severe plaque psoriasis are limited. In the 16-week double-blind placebo-controlled phase of the SPROUT trial, apremilast demonstrated efficacy vs. placebo in paediatric patients with psoriasis. OBJECTIVES: To evaluate the 52-week efficacy and safety of apremilast in SPROUT. METHODS: SPROUT was a phase III multicentre randomized double-blind placebo-controlled parallel-group study (NCT03701763). Patients were randomized 2 : 1 to receive apremilast 20 or 30 mg (for patients weighing 20 to < 50 kg or ≥ 50 kg at baseline, respectively) twice daily or placebo for 16 weeks, after which all patients received apremilast through week 52 (apremilast/apremilast or placebo/apremilast, respectively). Patients were aged 6-17 years and had moderate-to-severe psoriasis that was inadequately controlled by or intolerant to topical therapy. RESULTS: Of 245 patients randomized, 221 (apremilast/apremilast, n = 149; placebo/apremilast, n = 72) entered the apremilast extension phase and 186 (apremilast/apremilast, n = 125; placebo/apremilast, n = 61) completed 52 weeks. With continued apremilast treatment, rates of static Physician Global Assessment (sPGA) response (score of 0 or 1 with ≥ 2-point reduction from baseline) further improved from week 16 (30.1%) to week 52 (47.7%). In the placebo/apremilast group, sPGA response rates increased from 9.8% at week 16 to 44.4% at week 52. The proportions of patients with ≥ 75% reduction from baseline in Psoriasis Area and Severity Index increased from 42.3% at week 16 to 60.4% at week 52 in the apremilast/apremilast group and from 13.4% to 63.9% in the placebo/apremilast group. No new safety signals were observed. CONCLUSIONS: Improvements in clinical outcomes were sustained through 52 weeks with apremilast treatment in paediatric patients with moderate-to-severe psoriasis. Safety findings were consistent with the known safety profile.
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".