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MC2-01-C2 and MC2-01-C7 post hoc pooled analysis: Best and super-responders to calcipotriol and betamethasone dipropionate PAD-cream
Around 70–80% of patients in real-world clinical settings present with mild-to-moderate psoriasis. Calcipotriol (CAL) and betamethasone dipropionate (BDP) combination therapy is the first-line choice for topical psoriasis treatment, and polyaphron dispersion (PAD) technology has made the CAL/BDP combination a feasible approach in psoriasis management. A post hoc analysis evaluated best response to CAL/BDP PAD-cream vs CAL/BDP gel in patients with mild-to-moderate psoriasis enrolled in two phase III trials, MC2-01-C2 (NCT03308799) and MC2-01-C7 (NCT03802344). The results were published by Pinter et al. in Dermatology and Therapy.1 Patients in the mITT population (N = 1,271) were randomly allocated (3:1:3) to CAL/BDP PAD-cream (n = 551), PAD-cream vehicle (n = 178), and CAL/BDP gel (n = 542). Treatment responses were assessed by the proportion of patients achieving PGA 0/1, mPASI < 2, and DLQI 0/1 at Weeks 4 and 8. Best responders were defined as those achieving PGA-controlled disease (PGA 0/1 + mPASI < 2 + DLQI 0/1).
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Key learnings |
A higher proportion of patients achieved PGA-controlled disease in the CAL/BPD PAD-cream vs PAD-cream vehicle and CAL/BPD gel groups at 4 weeks (p < 0.001, each) and 8 weeks (p < 0.001, each). |
The proportion of best responders was higher in the CAL/BPD PAD-cream (10.7%) vs the CAL/BPD gel (6.1%; p = 0.0048) and vs the PAD-cream vehicle (0%; p = 0.0004) at 4 weeks. |
The proportion of best responders was higher in the CAL/BPD PAD-cream (27.4%) vs CAL/BPD gel (16.1%; p < 0.0001) and vs PAD-cream vehicle (3.9%; p < 0.0001) at 8 weeks. |
The NNT was higher for CAL/BDP PAD-cream best responders (4.3; 95% CI, 3.6–5.5) and CAL/BDP gel best responders (8.3; 95% CI, 6.2–14.3) compared with PAD-cream vehicle. |
Based on the CART model, 63.6% of patients with a baseline DLQI < 7 and mPASI < 4.0 achieved the best response at Week 8. |
CAL/BDP PAD-cream is more effective than gel or vehicle in mild-to-moderate psoriasis. Baseline DLQI and mPASI scores may help predict patient groups more likely to achieve best responses to CAL/BDP PAD-cream. |
BDP, betamethasone dipropionate; CAL, calcipotriol; CART, classification and regression tree; CI, confidence interval; DLQI, Dermatology Life Quality Index; mITT, modified intent-to-treat; mPASI, modified Psoriasis Area and Severity Index; NNT, number needed to treat; PAD, polymeric emulsion technology; PGA, Physician Global Assessment.
References
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