Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials
Abstract Introduction Individual endpoints from phase 3 trials demonstrated high efficacy and convenience for the calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology compared to CAL/BDP gel. The objectives are to assess the proportion of best respo...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2025-04-01
|
| Series: | Dermatology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s13555-025-01418-x |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | Abstract Introduction Individual endpoints from phase 3 trials demonstrated high efficacy and convenience for the calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology compared to CAL/BDP gel. The objectives are to assess the proportion of best responders to CAL/BDP PAD-cream at weeks 4 and 8 and to identify the super-responders through the patients’ key baseline characteristics associated with best response. Methods This was a post hoc pooled analysis of adult patients with mild-to-moderate psoriasis from two phase 3 trials: MC2-01-C2 (NCT03308799) and MC2-01-C7 (NCT03802344). Patients were randomly assigned (3:1:3) to CAL/BDP PAD-cream, PAD-cream vehicle, or CAL/BDP gel once daily. Best responders at weeks 4 and 8 were defined as patients achieving a restrictive endpoint comprising the combination of Physician’s Global Assessment (PGA) controlled disease, modified Psoriasis Area and Severity Index (mPASI) success, and Dermatology Life Quality Index (DLQI) satisfaction. Best response rates were compared between treatments by logistic regression using multiple imputation. A classification and regression tree (CART) based on observed cases identified super-responders through the key baseline characteristics associated with best response among CAL/BDP PAD-cream users. All analyses were based on the modified intention-to-treat (mITT) population. Results The mITT included 551 patients on CAL/BDP PAD-cream, 542 on CAL/BDP gel, and 178 on vehicle. The CAL/BDP PAD-cream group showed a statistically significant higher best response rate compared to CAL/BDP gel at week 4 (10.7% vs 6.1%; p = 0.0048) and week 8 (27.4% vs 16.1%; p < 0.0001), and also compared to vehicle. Among CAL/BDP PAD-cream users, 63.6% of patients with a baseline DLQI < 7 and mPASI < 4.0 achieved best response at week 8 and were considered super-responders. Conclusion CAL/BDP PAD-cream demonstrated higher best response rates compared to CAL/BDP gel and vehicle in adults with mild-to-moderate psoriasis. Baseline DLQI and mPASI scores may predict which patients are most likely to achieve best response to CAL/BDP PAD-cream. Trials Registration ClinicalTrials.gov identifiers, NCT03308799 (MC2-01-C2) and NCT03802344 (MC2-01-C7). |
|---|---|
| ISSN: | 2193-8210 2190-9172 |