This study critically appraises the available literature on topical treatments of psoriasis to specifically address some relevant issues, namely the vehicle associated with the highest effectiveness, the best vehicle for improving adherence, and the best strategy in terms of efficacy and safety for long-term treatment. |
The greater effectiveness of the foam formulation was demonstrated for calcipotriene/betamethasone dipropionate administration compared with the gel and ointment. |
Literature evidence and clinical experience reported high rates of acceptability and adherence for the foam vehicle. |
A growing consensus is shared among dermatologists sustaining the proactive approach as the best option for the long-term topical treatment of psoriasis in adults. |
Introduction
Methods
Project Overview
Research Questions
Literature Search
Search Criteria
Type of Publications
Study Eligibility Criteria
Critical Appraisal of Individual Studies
Results
Studies | Scoring | Classification | |||||||
---|---|---|---|---|---|---|---|---|---|
Title | Author, year | Study design | Reporting | Ext. validity | Int. validity—bias | Int. validity—selection bias | Power | Total Score | Rating |
A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed-dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis | Pinter (2022) [29] | Pooled analysis of two phase III clinical trials | 7 | 1 | 5 | 4 | 1 | 18 | Fair |
Patient satisfaction with calcipotriol/betamethasone dipropionate cutaneous foam for the treatment of plaque psoriasis: The LION real-life multicenter prospective observational cohort study | Campanati (2021) [23] | Observational study | 10 | 3 | 6 | 2 | 1 | 22 | Good |
Quality of life and patient-perceived symptoms in patients with psoriasis undergoing proactive or reactive management with the fixed-dose combination Cal/BD foam: A post-hoc analysis of PSO-LONG | Jalili (2022) [22] | Post-hoc analysis | 8 | 3 | 7 | 4 | 1 | 23 | Good |
Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial) | Lebwohl (2021) [43] | RCT | 10 | 3 | 7 | 5 | 1 | 26 | Excellent |
Calcipotriol/Betamethasone Dipropionate Aerosol Foam for Plaque Psoriasis: A Prospective, Observational, Non-Interventional, Single-Center Study of Patient Adherence and Satisfaction in Daily Use | Navarro-Triviño (2021) [38] | Observational study | 9 | 1 | 4 | 4 | 0 | 18 | Fair |
A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream | Stein Gold (2021) [28] | RCT | 9 | 3 | 4 | 4 | 1 | 21 | Good |
Patient and Physician Satisfaction with Calcipotriol and Betamethasone Dipropionate Aerosol Foam in the Treatment of Plaque Psoriasis on the Body | Velasco (2019) [42] | Observational study | 6 | 1 | 2 | 2 | 0 | 11 | Poor |
Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions | Gerdes (2017) [30] | Observational study | 7 | 3 | 5 | 2 | 0 | 17 | Fair |
Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO-INSIGHTFUL study | Hong (2017) [25] | RCT | 9 | 3 | 5 | 5 | 1 | 23 | Good |
Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study | Paul (2017) [26] | Subgroup analysis | 9 | 3 | 6 | 4 | 0 | 22 | Good |
Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study | Paul (2017) [24] | RCT | 10 | 3 | 6 | 4 | 1 | 24 | Good |
Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris–A randomized phase II study | Koo (2016) [27] | RCT | 10 | 3 | 6 | 5 | 0 | 24 | Good |
Real-life effectiveness of once-daily calcipotriol and betamethasone dipropionate gel vs ointment formulations in psoriasis vulgaris: final analysis of the 52-week PRO-long study | Lambert (2015) [39] | Observational study | 6 | 1 | 4 | 0 | 0 | 11 | Poor |
Practicability of combined treatment with calcipotriol/betamethasone gel (Daivobet® Gel) and improvement of quality of life in patients with psoriasis | Sticherling (2013) [31] | Observational study | 10 | 2 | 4 | 3 | 0 | 19 | Fair |
Bioavailability, antipsoriatic efficacy and tolerability of a new light cream with mometasone furoate 0.1% | Korting (2012) [40] | RCT | 5 | 0 | 4 | 4 | 0 | 13 | Poor |
The DESIRE study–psoriasis patients' satisfaction with topical treatment using a fixed combination of calcipotriol and betamethasone dipropionate in daily clinical practice | Claréus (2009) [32] | Observational study | 6 | 2 | 4 | 3 | 0 | 15 | Fair |
Calcitriol ointment 3 microg/g is safe and effective over 52 weeks for the treatment of mild to moderate plaque psoriasis | Lebwohl (2009) [20] | Clinical Trial | 6 | 3 | 4 | 3 | 0 | 16 | Fair |
A randomized, multicenter study of calcipotriene ointment and clobetasol propionate foam in the sequential treatment of localized plaque-type psoriasis: short- and long-term outcomes | Koo (2006) [33] | RCT | 6 | 0 | 6 | 4 | 0 | 16 | Fair |
A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris | Kragballe (2006) [21] | RCT | 10 | 3 | 6 | 6 | 1 | 26 | Excellent |
Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque-type psoriasis | Lowe (2005) [34] | RCT | 7 | 0 | 4 | 4 | 1 | 16 | Fair |
Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis | Decroix (2004) [35] | RCT | 7 | 0 | 6 | 3 | 0 | 16 | Fair |
Medication formulation affects quality of life: a randomized single-blind study of clobetasol propionate foam 0.05% compared with a combined program of clobetasol cream 0.05% and solution 0.05% for the treatment of psoriasis | Bergstrom (2003) [36] | RCT | 8 | 0 | 5 | 2 | 0 | 15 | Fair |
Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis | Sharma (2003) [37] | RCT | 9 | 0 | 5 | 1 | 0 | 15 | Fair |
Tacalcitol ointment for long-term control of chronic plaque psoriasis in dermatological practice | Lambert (2002) [41] | Clinical Trial | 6 | 1 | 3 | 1 | 0 | 11 | Poor |
Summary of Critical Appraisal
Research Question 1: Vehicle Associated with the Highest Effectiveness of the Opical Treatment of Psoriasis in Adults
Author, year | Study design | Study population | Treatment and vehicle | Main conclusions on the vehicle associated with the highest effectiveness |
---|---|---|---|---|
Pinter (2022) [29] | Pooled analysis of two different phase III clinical trials (NCT03308799; NCT03802344) | 1286 patients | Cal/BD cream vs Cal/BD topical suspension vs cream vehicle | PGA treatment success for the cream was greater than topical suspension (p < 0.0001) Mean percentage reduction in mPASI for the cream was greater than topical suspension (p < 0.0001) |
Stein Gold (2021) [28] | Phase III, multicenter, randomized, active, and vehicle-controlled trial | 796 patients | Cal/BD cream vs Cal/BD topical suspension | The proportion of patients achieving PGA treatment success after 8 weeks was greater for Cal/BD cream A similar statistically significant difference in favor of Cal/BD cream at week 8 was demonstrated for the percentage change in mPASI from baseline and the proportion of patients obtaining mPASI75 |
Paul (2017) [24] | Phase III, prospective, multicenter, investigator-blinded study (PSO-ABLE) | 463 patients | Cal/BD foam vs Cal/BD gel | Cal/BD foam achieved higher treatment success rates and mPASI75 by week 4 than Cal/BD gel by week 8 |
Paul (2017) [26] | Subgroup analysis of the phase III, prospective, multicenter, investigator-blinded PSO-ABLE study | 159 patients | Cal/BD foam vs Cal/BD gel | Cal/BD foam showed to be more effective compared with Cal/BD gel A greater percentage of patients achieved DLQI of 0/1 at weeks 4, 8, and 12 |
Koo (2016) [27] | Phase II, multicenter, investigator-blind, 4-week trial | 376 patients | Cal/BD foam vs Cal/BD ointment | Treatment success rates and mean percentage decrease in mPASI at week 4 was higher for the Cal/BD foam group Percentage of patients achieving PASI75 or PASI50 was not statistically significant |
Lowe (2005) [34] | Multicenter, randomized, active- and vehicle-controlled, parallel-group study | 192 patients | Clobetasol propionate lotion vs clobetasol propionate cream | Lotion and cream showed comparable efficacy profiles, which were superior to the vehicle, including a similar success rate at the end of the treatment period |
Decroix (2004) [35] | Multicenter, randomized, active- and vehicle-controlled, parallel-group study | 222 patients | Clobetasol propionate lotion vs clobetasol propionate cream | Lotion and cream showed comparable efficacy profiles, which were superior to the vehicle, including a similar success rate at the end of the treatment period |
Bergstrom (2003) [36] | Randomized, single-blind clinical trial | 32 patients | Clobetasol propionate foam vs a combined program of clobetasol cream and solution | PASI score decrease was higher for the foam In the treatment of scalp psoriasis, the foam had greater improvement than the combined treatment |
Research Question 2: Best Vehicle for Improving Patient Adherence to Topical Treatment of Psoriasis in Adults
Author, year | Study design | Study population | Treatment and vehicle | Main conclusions on the acceptability and/or adherence |
---|---|---|---|---|
Campanati (2021) [23] | Real-life multicenter prospective observational cohort study | 256 patients | Cal/BD foam | More than 90% of patients evaluated the Cal/BD foam as more effective, easier to use, and better tolerated than previous topical treatments |
Stein Gold (2021) [28] | Phase III, multicenter, randomized, active, and vehicle-controlled trial | 796 patients | Cal/BD cream vs Cal/BD topical suspension | Patient-reported treatment convenience for Cal/BD cream was rated superior to Cal/BD topical suspension |
Navarro-Triviño (2021) [38] | Prospective, observational, single-center study | 65 patients | Cal/BD foam | 74% of patients showed high adherence at 12 weeks 71% of patients were completely satisfied |
Gerdes (2018) [30] | Prospective, observational, non-interventional, multicenter study | 410 patients | Cal/BD foam | 82% of patients adhered to the Cal/BD foam therapy until the end of the 4-week observational period and were willing to continue the therapy thereafter |
Hong (2017) [25] | Phase IIIb, prospective, multicenter (Canada/Germany), open-label, randomized, two-arm crossover study | 213 patients | Cal/BD foam and gel | Based on the Topical Product Usability Questionnaire (TPUQ), mean scores were high for both Cal/BD foam and gel overall. Cal/BD foam was generally preferred by younger patients (aged 18–39 years) |
Sticherling (2013) [31] | Non-interventional, prospective trial | 579 patients | Cal/BD gel | 75% of patients were “very satisfied” with the Cal/BD gel vs 29% with the prior treatment Adherence was 95% 1 week after initiation of therapy and 81% after 4 weeks of treatment |
Claréus (2017) [32] | Multicenter, single-group, international, real-world study | 1224 patients | Cal/BD gel | 80% of patients were highly satisfied with the treatment |
Research Question 3: Best Strategy in Terms of Efficacy and Safety for the Long-Term Topical Treatment of Psoriasis in Adults
Author, year | Study design | Study population | Treatment and vehicle | Main conclusions on the strategy in terms of efficacy and safety for the long-term treatment |
---|---|---|---|---|
Jalili (2022) [22] | Post-hoc analysis of PSO-LONG | 545 patients | Cal/BD foam | Proactive management was associated with a significantly higher DLQI and a numerically lower EQ-5D-5L-PSO mean area under the curve score than proactive management |
Lebwohl (2021) [43] | Phase III, multicenter trial (PSO-LONG) | 545 patients | Cal/BD foam | Proactive management reduced the median time to first relapse and the number of relapses and increased the days in remission compared with reactive management The Cal/BD foam was well tolerated |
Lebwohl (2009) [20] | Open-label, multicenter study | 324 patients | Calcitriol ointment | A marked improvement in psoriasis symptoms from baseline was reported BSA was stable or improved in 97.7% of patients at 52 weeks Adverse events deemed related to study treatment were noted for 45 participants (14%), none was severe |
Koo (2006) [33] | Phase II, multicenter, investigator-blind randomized study | 86 patients | Clobetasol foam + calcipotriene ointment (6 months) followed by 6 months of weekday calcipotriene ointment ± clobetasol foam weekend pulse therapy | Combination therapy in the first 24 weeks decreased psoriasis scores compared with either agent The weekend pulse clobetasol foam was associated with a trend toward greater maintenance of remission than the vehicle |
Kragballe (2006) [21] | Randomized clinical trial | 422 patients | Cal/BD gel applied for 52 weeks vs 52 weeks of alternating 4 weeks of Cal/BD gel and calcipotriol (alternating group, n = 213) or 4 weeks of the Cal/BD gel + 48 weeks of calcipotriol | Adverse drug reactions of concern associated with long-term topical corticosteroids were comparable among the three groups, suggesting that Cal/BD gel is safe and well tolerated in the long term whether used on its own or alternating every 4 weeks with calcipotriol treatment |
Sharma (2003) [37] | Prospective, randomized study | 30 patients | Coal tar ointment on one side of the lesion and calcipotriol ointment on the other side | Calcipotriol ointment produced a faster initial response, although after a long period of treatment, i.e., 12 weeks, coal tar ointment had comparable efficacy There was no statistically significant difference in the relapse rates between the two modalities |