Matching-adjusted indirect comparison of efficacy outcomes in trials of calcipotriol plus betamethasone dipropionate foam and cream formulations for the treatment of plaque psoriasis

Abstract

Background and objectives

Once-daily, fixed-combination calcipotriol 50 μg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream.

Methods

Anchored and unanchored MAIC analyses were conducted using individual patient data (IPD) from five Cal/BD foam trials and two trials of Cal/BD cream. Outcomes of interest were the proportion of patients with Physician's Global Assessment (PGA) success and the mean reduction in modified Psoriasis Area and Severity Index (mPASI).

Results

In the anchored MAIC, patients were more likely to achieve PGA success after 4 weeks of Cal/BD foam than after 8 weeks of Cal/BD cream and had larger mean improvements in mPASI (p < .01 in EU mPASI analysis). In unanchored analyses, 4 weeks of Cal/BD foam treatment was statistically significantly more efficacious in inducing PGA success than 8 weeks of Cal/BD cream (p < .01 in five of six comparisons). Mean reductions in mPASI were consistently statistically significantly greater with Cal/BD foam than with Cal/BD cream.

Conclusions

Use of Cal/BD foam consistently shows significantly greater improvements in PGA and mPASI outcomes, compared with Cal/BD cream.

Keywords:

• Psoriasis
• calcipotriol
• betamethasone dipropionate
• foam

Acknowledgments

Medical writing support was provided by Symmetron Ltd (London, UK) and Beacon Medical Communications Ltd (Brighton, UK) in accordance with Good Publication Practice (GPP3) guidelines, and was funded by LEO Pharma (Ballerup, Denmark).

Disclosure statement

KP has received honoraria for advisory board, speaker, consultant services, scientific officer and/or steering committees from AbbVie, Akros, Amgen, Bausch Health/Valeant, Boehringer Ingelheim, Celgene, Celltrion, Coherus, Eli Lilly, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Takeda, UCB, vTv Therapeutics and Xencor; and has received research grants from AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Medimmune, Merck (MSD), Merck- Serono, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda and UCB. HT, HB and MYJB are employees of LEO Pharma. SG has been an adviser and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of AbbVie, Affibody AB, Akari Therapeutics Plc, Almirall-Hermal, Amgen, Anaptys Bio, Argenx BV, AstraZeneca AB, Biogen Idec, Bioskin, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly, Foamix, Forward Pharma, Galderma, Hexal AG, Incyte Inc., Janssen-Cilag, Johnson & Johnson, Kymab, LEO Pharma, Medac, MSD, Neubourg Skin Care GmbH, Novartis, Pfizer, Principia Biopharma, Regeneron Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi-Aventis, Trevi Therapeutics and UCB Pharma. MM has been an adviser and/or received speakers’ honoraria for AbbVie, Eli Lilly, Novartis, LEO Pharma, UCB, Janssen, Novartis and Amgen. OY has received speaker honoraria from LEO Pharma, Merck (MSD) and Bristol-Myers Squibb; and acted as a consultant for Almirall, Isispharma and LEO Pharma.

Additional information

Funding

This study was funded by LEO Pharma. The authors did not receive honoraria for participating in the study.