Apremilast,
does it really help with Reduced oral-ulcer burden in Behcet syndrome without major-organ involvement?
research showsThe grade is C with 50 points. In the 207-person phase 3 trial, the 12-week oral-ulcer-count AUC was 129.5 with apremilast versus 222.1 with placebo, adjusted difference -92.6 (95% CI -130.6 to -54.6; P<.001). Neither the article nor the protocol provides a validated minimum important difference for this AUC, so the standardized effect-size tier was used. A standard error of 19.4 recovered from the 95% confidence interval and a pooled standard deviation of 139.5 calculated from the two groups of 104 and 103 give a standardized difference of about 0.66, above the conventional moderate threshold of 0.5. Exclusive Celgene funding (I0), not axis 4, caps the grade at C.
ads claimLower ulcer counts and pain are real, but the AUC number does not establish a validated patient-perceived minimum difference.
Useful facts when choosing a product
- Apremilast is an oral prescription PDE4 inhibitor.
- The pivotal trial enrolled patients with active oral ulcers, no major-organ involvement, and no previous biologic therapy for oral ulcers.
- NCT02307513 prespecified oral-ulcer-count AUC from baseline through week 12.
What the research actually shows
This double-blind placebo-controlled phase 3 trial at 53 centers randomized 207 patients. Everyone received at least one dose, making the modified intention-to-treat set equivalent to all randomized participants. Twelve-week completion was 96/104 with apremilast and 83/103 with placebo; prespecified multiple imputation and sensitivity analyses addressed missing primary AUC counts. Neither the article nor the protocol provides a validated minimum important difference for the AUC. The confidence-interval width gives a standard error of 19.4 for the contrast; with groups of 104 and 103, this corresponds to a pooled standard deviation of 139.5 and a standardized adjusted difference of about 0.66. The article also reports oral-ulcer pain on a 100-mm VAS as a secondary endpoint but gives no minimum important difference threshold for it. The article reports stratification by sex, uveitis history, and region but does not identify how upcoming allocation was concealed, counted as one reporting limitation. The AUC primary outcome matched NCT02307513. Celgene fully funded the trial; the earlier phase 2 study belonged to the same company program and overlapped in investigators, so it was not counted as independent replication.
Why this is classified as C (50)
The standardized AUC difference of about 0.66 exceeds the conventional moderate threshold, making axis 4 E+, but exclusive Celgene funding makes axis 3 I0 and caps the grade at C with 50 points.
Counterpoint. This verdict is limited to oral ulcers and does not establish efficacy for major-organ disease.
Rejudgment record. Cross-check applied — Cross-checked the article and NCT02307513 for AUC, multiple imputation, analysis set, prespecified endpoint, and Celgene funding, then approximated the standardized adjusted contrast from its confidence interval
| Endpoint | P | Patient-reported treatment goal - the symptom is the goal |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Reduced 12-week oral-ulcer burden | C | AUC was significantly lower, with an approximate standardized difference of about 0.66. |
| Improvement in major-organ involvement | ? | Patients with active major-organ involvement were excluded. |
Cross-check — Codex and Claude
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Study 1 | Multinational double-blind placebo-controlled phase 3 randomized trial | 103 | Funded by Celgene | Oral-ulcer-count AUC from baseline through week 12 | 129.5 versus 222.1; adjusted difference -92.6 (95% CI -130.6 to -54.6), P<.001 | Confirmatory trial above a moderate standardized effect but fully manufacturer-funded |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-18).
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-18 · Corrections: none
Cite this verdict
[Chamgap] Apremilast x oral ulcers in Behcet syndrome — Evidence Grade C·50. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/apremilast-behcet-oral-ulcers/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.