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Topical betamethasone in the treatment of chronic plaque psoriasis: a review.

Introduction

Psoriasis affects 0.5-4.6% of the population worldwide [1]. Most patients require lifelong treatment with unpredictable periods of remission and relapse [2] and patients' quality of life is seriously affected [3-5]. Chronic plaque psoriasis, the most common manifestation, ranges in severity from mild to severe. The goals of psoriasis treatment are to gain rapid control of disease, achieve and maintain long-term remission, minimise adverse effects and improve quality of life. In the first of two reviews of topical treatments of plaque psoriasis in this issue, betamethasone valerate is considered here.

Topical therapies are used to treat mild to moderate localised psoriasis, whereas severe and widespread forms need systemic treatment or phototherapy. The aim of treatment is to diminish lesions rather than achieve complete clearance [6]. Effective treatment of psoriasis by topical preparations is mainly dependent upon patient compliance [7].

Corticosteroids

In the United States topical corticosteroids are the most commonly used treatments despite the introduction of newer, non-steroidal agents [8-10]. They are rapidly effective, safe, easy to use and relatively inexpensive [11]. They should only be used to treat psoriasis affecting less than 20% of the body surface area [11]. Their potencies range from 'super potent' to least potent (classes 1-7) according to the Stoughton-Cornell classification based on the vasoconstrictor assay [12,13]. They act as antimitotic agents in the epidermis by influencing gene transcription resulting in inhibition of the immunological, inflammatory and proliferative processes of the disease [14-16].

Clinical effectiveness is influenced by chemical composition and vehicle type, which later determines differences in percutaneous absorption. Ointments have greater penetration than creams and lotions but penetration can be augmented by occlusion [17].

Betamethasone 17 valerate

Since betamethasone valerate (BV) is mid-potency it is preferred for initial treatment of most body areas of adults and for maintenance of mild psoriasis [11]. Vehicle types subdivide mid-potency BV into three classes, listed by potency level in Table 1 [18].

BV as 0.1% ointment was less efficacious in plaque psoriasis therapy than 0.05% halobetasol propionate ointment [19]. The onset of a therapeutic effect was reported within 5 days of the start of treatment in 66.7% and 76.2% of the patients in the betamethasone valerate ointment and halobetasol propionate ointment treatment groups, respectively. The assessment of patients at the end of 4 weeks showed healing or marked improvement in 63.4% of the 0.1% BV ointment patients and 88.1% with halobetasol propionate 0.05% ointment. 0.1% BV ointment showed less improvement in plaque psoriasis and a shorter remission period than clobetasol propionate 0.05% ointment [20].

In comparison with a synthetic analogue of vitamin D3, 0.1% BV ointment was as effective as calcipotriol ointment for plaque psoriasis [21]. The maximum rate of improvement was in the first 2 weeks when the reduction in modified Psoriasis Area and Severity Index (PASI) score was 32% and 34% for 0.1% BV ointment group and calcipotriol ointment group, respectively. The PASI reached 52% in BV 0.1% ointment group and 58% in calcipotriol ointment group at the end of 6 weeks. The analysis of patient assessments at 6 weeks showed clearance or marked improvement in 50.5% with 0.1% BV ointment group and in 61.2% with calcipotriol ointment group. According to these studies, 0.1% BV ointment, was less effective than super potent (class 1) corticosteroid ointment and had equal efficacy with calcipotriol ointment. It showed good efficacy and early therapeutic effect and was safe and well-tolerated.

Halcinonide cream (0.1%) was superior to 0.1% BV cream under occlusion for the treatment of moderate to severe psoriasis [22]. The percentage of patients treated with BV cream for 2 weeks achieving excellent and good improvement was about 38.7% and 36.7%, respectively, whereas after 2 weeks of treatment with 0.1% halcinonide cream, the response rate was 48.9% and 36.7% for excellent and good improvement, respectively. In addition, BV cream was similar to mid-potency 0.05% fluticasone propionate cream [23]. These studies demonstrated that 0.1% BV cream had efficacy similar to the lower midstrength (class 5) corticosteroid [18]. BV cream (0.1%) was as effective as calcipotriol cream in the inhibition of both cell proliferation and inflammation [24]. The mean percentage reduction of PASI from baseline to the end of 8 weeks was 45.4% in the BV cream treatment group and 47.8% in the calcipotriol cream group. The investigators' overall assessment of treatment response showed 56% of patients treated with BV cream cleared or achieved marked improvement at the end of 8 weeks compared with 58% of the calcipotriol cream treated patients. BV cream (0.1%) is one of the standard treatments for psoriasis in Thailand and reportedly it is effective for treatment of mild to moderate psoriasis vulgaris [25-27]. The mean percentage reduction in PASI score from baseline until the end of 6 weeks was 69.36% with 0.1% BV cream [25]. The overall assessment of treatment response at the end of 6 weeks showed 76.6% of patients treated with the BV cream had cleared or achieved marked improvement [25]. These studies concluded that BV cream was effective, safe and well-tolerated and about equal in effect to calcipotriol cream.

A recent study revealed that 0.1% BV cream was more potent than 1% pimecrolimus cream for intertriginous psoriasis [28]. From baseline to the end of treatment (day 28), the mean M-PASI scores significantly decreased by 86.4% for 0.1% BV cream and 39.7% for 1% pimecrolimus cream. The VAS score for pruritus decreased by 78% for 0.1% BV cream and 35% for 1% pimecrolimus cream. Owing to the adverse-effect profile of long-term application of corticosteroids, occasional or intermittent rescue therapy with short-term topical corticosteroids and maintenance with less potent agents, such as 1% pimecrolimus, 0.1% tacrolimus or 0.005% calcipotriol, might be appropriate for patients with inverse psoriasis [28].

BV solution, in most countries, is preferred for the treatment of scalp psoriasis [29,30]. BV (0.1%) solution was more effective than 0.005% calcipotriol solution in treatment of mild-to-moderate scalp psoriasis [29]. At the end of 4 weeks, the proportion of patients who had cleared or had marked improvement was significantly greater in the BV solution therapy group (75%) than in the calcipotriol solution group (58%). In addition, the mean percentage reduction in the PASI score from baseline to the end of 4 weeks was statistically significantly greater in the BV solution group (61.6%) than the calcipotriol solution group (45.2%). It was also superior to calcipotriol in reducing scalp flaking and itching, and caused less local irritation on the scalp and face [29]. In general, the more potent 0.1% BV lotion preparation was used for scalp psoriasis therapy in adults but for children less potent corticosteroids such as hydrocortisone butyrate (0.1%) and prednicarbate (0.1%) were preferred [31]. BV solution for scalp psoriasis was more efficacious and a lesser skin irritant than calcipotriol solution. The long-term treatment of scalp psoriasis with BV solution is not recommended because of adverse effects [32].

BV foam (0.12%) produced significantly greater improvement for scalp psoriasis than its lotion formulations [33]. This study showed that BV foam penetration into the skin was more than double that of the lotion product and the enhancement of absorption led to increased efficacy [33]. Of patients using BV foam, 72% were clear or almost clear of disease at the end of 28 days as judged by the investigators' global assessment of response. Only 47% of BV lotion patients showed a similar response. Based on the investigators' global assessment, there was a 53% increase in efficacy in the foam group when compared to the lotion group. Both agents, however, shared the same efficacy for pruritus. Moreover, 0.12% BV foam produced greater improvements in scalp psoriasis than lotion-based betamethasone diproprionate, mometasone or calcipotriol lotion [34]. With BV foam treatment, 88% of patients had complete or nearly complete resolution of scaling in comparison with 66% of betamethasone diproprionate, mometasone or calcipotriol lotion. Patients preferred the foam vehicle over the cream, gel, solution and ointment formulations for scalp psoriasis since it was better cosmetically and provided greater efficacy, and improved their perceived quality of life [35,36].

BV foam (0.12%) was also effective in treating non-scalp psoriasis [37] applied twice daily in the morning and evening, with 70% of patients achieving a PASI score of 50 at the end of 12 weeks. The foam formulation was absorbed rapidly and demonstrated greater total absorption in comparison with the lotion formula. The bioavailability of BV was nearly 300% greater with foam than with lotion [38]. A recent study showed that 0.12% BV foam may be applied once rather than twice daily with the same results and improved patient compliance [39]. In summary, the foam formulation with enhanced BV bioavailability provided a highly efficacious, cosmetically superior, and well-tolerated treatment of non-scalp psoriasis compared with currently available topical formulations.

Combination of topical betamethasone valerate with other agents

The efficacy of 0.1% BV scalp application was enhanced when used in conjunction with a 10% glycolic acid scalp lotion [40]. The duration of treatment required for healing in this case was reduced to approximately half that needed when the glycolic acid or BV lotions were used separately. The combination with the exfoliative agent was beneficial for treatment of severe scalp psoriasis and was safer and better tolerated than BV lotion alone.

The combination of calcipotriol and BV ointment was more effective than BV or calcipotriol ointments alone for plaque psoriasis [41]. They work by interacting with different receptor subtypes (e.g. vitamin D or glucocorticoid receptors) in an additive or synergistic way as would be expected theoretically [41]. The mean PASI score decreased from 5.7 at the beginning of therapy with the combination to 1.0 after 6 weeks. In the calcipotriol ointment therapy, the mean PASI decreased from 6.2 at the beginning of therapy to 1.9 after 6 weeks. This combination tended to reduce the adverse effects associated with the long-term use of topical corticosteroids such as atrophy and rebound, as well as the irritation associated with calcipotriol.

A flow-cytometric study confirmed that calcipotriol in combination with BV cream was more effective than calcipotriol cream alone [42]. This study reported that the reduction in the percentage of basal keratinocytes in S- and G2M phase (proliferation) by calcipotriol with BV cream was greater than by calcipotriol cream alone. This confirmed that the combination therapy was beneficial over monotherapy.

The combination of tazarotene cream and 0.12% BV foam was an effective approach for treating localised plaque-type psoriasis [43]. The BV foam was used in the morning and 0.1% tazarotene cream in the evening. Eight of the nine patients showed improvement by week 12. This combination helped alleviate the adverse effects, especially the local irritation caused by tazarotene.

Safety and tolerability

BV ointment (0.1%) was in general safe and well tolerated [19,21]. Adverse effects such as burning sensations, pruritus and secondary infection at the application site were reported by only 2% of patients [19]. However, 8.3% of the patients treated with BV ointment withdrew from the trial due to skin infections and/or unsatisfactory treatment response [21]. The ointment base itself was acceptable but the incidence of skin infections was high.

BV cream (0.1%) was effective, safe and well-tolerated, and no patients withdrew from the study [25]. The adverse effects reported during this study were only mild irritation with itching. In many countries this mid-potency corticosteroid is one of the most frequently prescribed corticosteroids for the treatment of psoriasis [24] In Molin et al.'s study only 3.3% of the patients in the 0.1% BV cream group withdrew, and the most frequent reason given was skin irritation [24]. The cream base prescribed was a popular formulation and there was patient satisfaction, however, it caused more local adverse effects.

BV solution (0.1%) was safe and well tolerated in the treatment of scalp psoriasis [29,44]. Only 1% of patients using 0.1% BV solution withdrew because of adverse events or an unacceptable treatment response [29]. The patients reported that treatment with 0.1% BV solution was acceptable in terms of greasiness, ease of application and odour, with over 95% of patients finding it acceptable, good or excellent [29]. Although the solution induced the highest incidence of skin irritation it was acceptable in being less greasy and odorous.

The safety profile of BV foam was similar to that of other BV formulations [33]. BV foam (0.12%) yielded better patient compliance and improved perceived quality of life, compared with its lotion form [33]. In another study, there was significantly greater patient acceptance with BV foam versus lotion-based betamethasone dipropionate and mometasone or calcipotriol lotion therapies [34]. Foam vehicles were safe and well tolerated and cosmetically acceptable.

Relapse

The relapse rate for BV solution for the treatment of scalp psoriasis was 79.1% over 4 weeks of observation after stopping therapy and was the same as for calcipotriol solution [29]. This study reported that the average remission was 2 weeks of treatment with 0.1% BV ointment, and 4 weeks with clobetasol propionate 0.05% ointment [20]. In another study, treatment by combination of calcipotriol and BV ointment, the PASI score rose from 1.0 at the end of trial to 2.4 in 8 weeks [41]. Thus treatment with BV resulted in short remissions but high relapse rates.

Adverse effects

About 4% of patients, treated with 0.1% BV ointment, developed lesional and perilesional irritation [21]. They experienced a slight burning or itching after application but with no reaction visible on the skin. In most cases, the irritation was mild and tended to subside with continued treatment. There was almost no facial irritation with BV ointment. Secondary skin infection was about 2.5% in patients who used BV ointment [19, 21]. Patients treated with 0.1% BV ointment for 6 months showed no hypothalamic-pituitary-adrenal (HPA) axis suppression [20]. The ointment base of BV caused less irritation and no cortisol suppression but produced high skin infectivity.

Lesional and perilesional irritation with 0.1% BV cream was as high as 9% [24] and facial irritation occurred in 0.5% of patients. As a topical corticosteroid, it may exacerbate pre-existing or coexistent dermatitis such as perioral dermatitis or rosacea [18,45]. The study also noted that three of 207 cases in the BV cream treatment group developed early skin atrophy at the end of 8 weeks [24]. The incidence of local adverse effects of the cream base was high but they were only mild skin reactions and there was almost no facial irritation.

Plasma cortisol was not suppressed by betamethasone valerate 0.1% cream applied twice daily without occlusion to approximately one-third of the body over psoriatic lesions for 6 months [46]. However, systemic toxicity was related to the degree of absorption of corticosteroid through the skin into the systemic circulation and to the duration of treatment and area of application. The site of application was an important factor because there was a marked regional variation in percutaneous absorption of the active ingredient from topical preparations. The study asserted that the cream base did not suppress the HPA axis even though it was used over a large body surface area.

The most common adverse effects of scalp psoriasis treated by BV solution were lesional or perilesional irritation and this was reported by 8.1% of patients [29]. In contrast, calcipotriol solution, which was used frequently in scalp psoriasis, induced these side-effects in about 26% of patients. Facial irritation rarely occurred in the BV solution group (0.4%). In order to reduce the adverse effects of BV lotion, intermittent use was recommended, either alone or combined with vitamin D3 derivatives on the other days of the week [31]. Solutions were cosmetically acceptable but caused high local irritation at application sites.

The most often reported adverse events with BV foam were burning, stinging or itching at the application site, but all of these were mild [33-35,37,39]. These reactions were most probably caused by the alcohol present in the foam and lotion formulations [33]. The proportion of patients reporting adverse events or the incidence of treatment-related adverse events typically did not significantly differ between the foam formulations and placebo or other standard topical medications used to treat psoriasis [33,36]. Although, the efficacy of foam vehicles was higher than with other formulations, they caused only mild local adverse effects and equal incidence to others.

The effect of BV foam on the HPA axis was compared to that of BV ointment in psoriasis patients with widespread disease (e.g. >30% body surface area) [33]. The assessment of relative bioavailability showed BV foam penetration into the skin to be more than two-fold greater than from the lotion [33]. However, there was no evidence of increased toxicity or HPA-axis suppression for either foam or ointment [33]. In addition, the foam formula was absorbed more rapidly and to a greater extent in comparison with the lotion formulation. Despite this, the study showed that there was little chance of the foam inducing HPA-axis suppression, even though application was to a large portion of the body surface [36]. These studies demonstrated that although foam vehicles enhanced absorption they did not suppress plasma cortisol.

Conclusions

All formulations of topical betamethasone 17-valerate seem to be safe, effective and tolerable in the treatment of scalp and non-scalp psoriasis. Adverse effects are likely to occur at the site of application and are similar to those produced by mid-potency corticosteroids.

Acknowledgements

The author wishes to thank Professor Graeme Beardmore and Dr Lynda Spelman, Queensland Institute of Dermatology, Greenslopes Private Hospital, Brisbane, Australia for their assistance. Many thanks should also go to Professor John Marley, Faculty of Health Sciences, the University of Queensland, Brisbane, Australia for his advice. The author also thanks Dr Akaraphanth Rutsanee, Institute of Dermatology, Bangkok, Thailand for her advice.

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Correspondence to: Dr Thawornchaisit Prasutr, Department of Medicine, Lerdsin General Hospital, Bangkok, 10500, Thailand. (email: prasutt@yahoo.com)

Thawornchaisit Prasutr

Department of Medicine, Lerdsin General Hospital, Bangkok, Thailand
Table 1: Betamethasone valerate potency chart (adapted from [18]).

Strength Generic name Vehicle types and
 concentration

Class 3 upper Betamethasone Ointment, 0.1%
mid strength valerate

Class 4 midstrength Betamethasone Foam, 0.12%
 valerate

Class 5 lo wer Betamethasone Cream/lotion,
mid strength valerate 0.1%
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Title Annotation:Leading Article
Author:Prasutr, Thawornchaisit
Publication:Clinical Dermatology
Article Type:Clinical report
Date:Mar 1, 2008
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