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Abstract
Objectives:
To evaluate the two-compound formulation (TCF) calcipotriol and betamethasone dipropionate (BDP) gel versus other topical therapies for scalp psoriasis in adults using direct and indirect comparisons.
Methods:
A systematic review identified 10 randomised controlled trials (RCTs) of topical treatments used in clinical practice for moderately severe scalp psoriasis. A meta-analysis was undertaken to obtain estimates of clinical effectiveness using recommended efficacy and safety outcome measures. We determined the proportion of responding patients using two definitions: i) ‘controlled disease’ using the Investigator Global Assessment (IGA) rating scale and ii) a score of 0 or 1 on the Total Sign Score (TSS). Tolerability was extracted in terms of percentages of patients experiencing all adverse events (AEs), skin AEs and withdrawals due to AEs. Direct comparisons were performed where head-to-head data were available. For other comparators where TCF gel was compared indirectly, ‘pairs’ of trials were compared on the basis of a common comparator using meta-regression in order to derive an indirect comparison estimate, while preserving randomisation within trials. Assumptions of comparability were considered regarding study homogeneity (data can be pooled in a meta-analysis), similarity of trials (clinical and methodological) and consistency of findings from direct and indirect evidence.
Results:
The meta-analysis showed that TCF gel was statistically significantly more effective than other topical treatments in terms of achieving a response defined according to both IGA and TSS criteria. TCF gel was generally associated with a statistically significant lower risk of AEs, skin AEs or patients withdrawing from RCTs due to AEs.
Conclusions:
Although direct and indirect evidence in this analysis is sparse, this indirect comparison suggests that the TCF gel has significant benefits over other topical therapies considered in the routine management of patients with moderately severe scalp psoriasis. Despite other analysis limitations in terms of study heterogeneity inevitable across an evidence base spanning decades, these results were consistent, using a number of efficacy and tolerability outcome measures.
Transparency
Declaration of funding
This analysis and the drafting of the manuscript were funded by LEO Pharma A/S. The work of Amygdala Limited was funded by LEO Pharma A/S.
Declaration of financial/other relationships
J.R. has disclosed that he is an employee of LEO Pharma UK. J.B. has disclosed that she is an employee of Amygdala Ltd and has received funding from LEO Pharma. R.T. has received consultancy fees from LEO Pharma.
Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.
Acknowledgements
The authors would like to thank the author of one study who responded to their request for additional information.
Notes
* Xamiol is a registered trademark of LEO Pharma A/S, Ballerup, Denmark.
† Polytar is a registered trademark of Stiefel Laboratories Ltd.
‡ Betnovate Scalp Application is a registered trademark of GlaxoSmithKline.
§ Capasal is a registered trademark of Dermal Laboratories Ltd.
¶ Dovonex Scalp Solution is a registered trademark of LEO Pharma.
* The Total Sign Score (TSS) is the sum of the separately assessed clinical signs for redness, thickness and scaliness. Each sign is scored with a number from 0–4 where 0 = no signs; 1 = slight signs; 2 = moderate signs; 3 = severe signs; 4 = very severe signs. The TSS is equal to Redness plus Thickness plus Scaliness. Thus TSS has a score range of 0–12 (ranging from ‘no symptoms’ to ‘very severe symptoms’. Inclusion of this measure in the indirect comparison enabled comparison with previous published studies in scalp psoriasis that had used this efficacy measure.