INTRODUCTION
Topical corticosteroids (TCS) continue to be a mainstay of primary and/or adjunctive therapy for all severities of psoriasis. Corticosteroid-containing topical medications include both monotherapy and combination formulations with vitamin D or vitamin A derivatives. The American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF) recently published joint guidelines on the use of topical therapies in psoriasis.1 Since its publication, additional advancements in TCS have generated new evidence that requires evaluation and interpretation.
A group of dermatologists with expertise in the treatment of psoriasis gathered to evaluate current evidence on corticosteroid-containing topical medications and participated in a Delphi consensus process to generate statements that reflect the current state of evidence and help guide clinician decision-making. This Delphi consensus process aims to evaluate current evidence and generate consensus statements on the (1) speed of onset of action, (2) depth of response, (3) maintenance of effect, (4) patient’s quality of life (QoL), (5) frequency of application, (6) "feel" of the medication on the skin, (7) application site reactions, (8) comparison of combination and monotherapy TCS, (9) for long-term side effects.
A group of dermatologists with expertise in the treatment of psoriasis gathered to evaluate current evidence on corticosteroid-containing topical medications and participated in a Delphi consensus process to generate statements that reflect the current state of evidence and help guide clinician decision-making. This Delphi consensus process aims to evaluate current evidence and generate consensus statements on the (1) speed of onset of action, (2) depth of response, (3) maintenance of effect, (4) patient’s quality of life (QoL), (5) frequency of application, (6) "feel" of the medication on the skin, (7) application site reactions, (8) comparison of combination and monotherapy TCS, (9) for long-term side effects.
MATERIALS AND METHODS
A Psoriasis Expert Group (PEG) consisting of board-certified dermatologists with expertise in the topical treatment of psoriasis was convened. A narrative review of TCS-containing therapies was performed, including monotherapy and combination formulations with nonsteroidal analogs, such as betamethasone dipropionate/calcipotriene (CAL/BDP) and halobetasol propionate (HP)/tazarotene (TAZ).
The degree of agreement with statements 3a and 3b is high. Patients experience more treatment satisfaction with psoriasis therapies that exhibit long-term efficacy. In the PSO-LONG Phase III RCT consisting of 545 patients, patients randomized to proactive treatment with CAL/BDP foam demonstrated an
The PEG met in person to address 10 core consensus statements about topical therapies for the treatment of psoriasis. A modified Delphi process based on the RAND appropriateness method was used to establish new treatment recommendations. Participants voted on a scale of 1 to 9 for each consensus statement. Panel consensus was determined as: (1) high if all panelists' votes fell into a single tertile, (2) low if 25% or more votes fell in the 1 to 3 range with concurrent 25% or more votes in the 7 to 9 range, and (3) moderate for all other combinations. It was determined a priori that a maximum of 2 rounds of voting would be performed, and only 1 round of voting would be needed if a high consensus was achieved within the first round of voting. The voting results were analyzed by an independent scholar.
Expert Guidance Consensus Statements 1 to 9
Consensus Statement 1:
1a: Topical therapies with a faster onset of action are preferred by patients.
1b: Topical therapies with a faster onset of action are preferred by clinicians.
The degree of agreement with statement 1a is high. The degree of agreement with statement 1b is moderate. Patients may prefer treatments that result in rapid improvement of their psoriasis, allowing them to experience a faster normalization in their QoL and daily activities.2 For example, CAL/BDP cream demonstrated improvement as early as week 1, and significant PGA treatment success by week 4 compared with CAL/BDP topical suspension (40.1% vs 24.0%, P<0.0001).3 Those on CAL/BDP cream experienced a significantly higher improvement in QoL in comparison with those using the topical suspension (43.8% vs 34.2%, P=0.0005).3
The degree of agreement with statement 1a is high. The degree of agreement with statement 1b is moderate. Patients may prefer treatments that result in rapid improvement of their psoriasis, allowing them to experience a faster normalization in their QoL and daily activities.2 For example, CAL/BDP cream demonstrated improvement as early as week 1, and significant PGA treatment success by week 4 compared with CAL/BDP topical suspension (40.1% vs 24.0%, P<0.0001).3 Those on CAL/BDP cream experienced a significantly higher improvement in QoL in comparison with those using the topical suspension (43.8% vs 34.2%, P=0.0005).3
In another study, combination CAL/BDP ointment resulted in significant reduction in Psoriasis Area and Severity Index (PASI) score as early as week 1 of treatment in comparison with CAL monotherapy or BDP alone (P<0.001).4 A systematic review examining treatment preferences among 35,388 psoriasis patients demonstrated that patients preferred treatments with faster onset of action.5 Thus, patients prefer treatments with faster onset of action that results in rapid improvement.
Consensus Statement 2:
2a: Topical therapies with higher efficacy are preferred by patients.
2b: Topical therapies with higher efficacy are preferred by clinicians.
The degree of agreement with statements 2a and 2b is high. Selecting treatments with maximal efficacy is important to patients so that they can achieve skin clearance and improve their QoL. For example, in a phase 3 randomized control trial (RCT), 43.2% of patients on CAL/BDP cream demonstrated significant Provider Global Assessment (PGA) treatment success over an 8-week treatment period in comparison with 31.9% of those on CAL/BDP topical suspension and 5.2% of those on vehicle (P<0.001).3
Furthermore, another phase 3 RCT showed a significant percentage reduction in mean PASI score from baseline by week 8 (P<0.0001) and significant itch reduction by week 4 (P<0.01) with CAL/BDP cream vs CAL/BDP topical suspension or vehicle.6 CAL/BDP ointment demonstrated significant PGA treatment success after a 4-week treatment period, with 48.0% of subjects on CAL/BDP ointment experiencing absent or very mild disease in comparison with 16.5% of those on calcipotriene only and 26.3% of those on betamethasone dipropionate only.7
Furthermore, CAL/BDP ointment resulted in significant percentage reduction in PASI score as early as week 1 of treatment in comparison with CAL or BDP monotherapy (P<0.001).5 Similarly, Kaufmann et al showed that 37.0% of patients on combination CAL/BDP ointment experienced treatment success, defined by mean reduction in PASI, in comparison with 22.3% in the CAL only group and 10.2% in the vehicle group (P<0.001).8 Significantly more patients on CAL/BDP foam achieved PGA treatment success compared with those on CAL (45% vs 14.9%, P<0.001) or BDP foam (45% vs 30.7%, P=0.047).9
For scalp psoriasis, more patients achieved PGA treatment success with CAL/BDP vs CAL foam (53.0% vs 35.6%, P=0.021), but not those on BDP foam.9 CAL/BDP foam also demonstrated significant reduction in mean mPASI score at the end of a 4-week treatment period vs CAL or BDP foam (71% vs 42% vs 55%) respectively, P<0.003 for PASI50 in both comparisons).9 Thus, patients prefer treatments with excellent efficacy because they offer significant improvement in psoriasis.
Consensus Statement 3:
3a: Topical therapies with maintenance of effect and/or durability are preferred by patients.
3b: Topical therapies with maintenance of effect and/or durability are preferred by clinicians.
The degree of agreement with statements 3a and 3b is high. Patients experience more treatment satisfaction with psoriasis therapies that exhibit long-term efficacy. In the PSO-LONG Phase III RCT consisting of 545 patients, patients randomized to proactive treatment with CAL/BDP foam demonstrated an
