Original Research

Safety and Efficacy of Halobetasol Propionate Lotion 0.01% in the Treatment of Moderate to Severe Plaque Psoriasis: A Pooled Analysis of 2 Phase 3 Studies

Cutis. 2019 February;103(2):111-116, E1-E3

References

Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007;25:535-546.
Liu Y, Krueger JG, Bowcock AM. Psoriasis: genetic associations and immune system changes. Genes Immun. 2007;8:1-12.
Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009;361:496-509.
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. section 3. guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60:643-659.
Alinia H, Moradi Tuchayi S, Smith JA, et al. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017;176:759-764.
Young M, Aldredge L, Parker P. Psoriasis for the primary care practitioner. J Am Assoc Nurse Pract. 2017;29:157-178.
Devaux S, Castela A, Archier E, et al. Adherence to topical treatment in psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol. 2012;26(suppl 3):61-67.
Ersser SJ, Cowdell FC, Latter SM, et al. Self-management experiences in adults with mild-moderate psoriasis: an exploratory study and implications for improved support. Br J Dermatol. 2010;163:1044-1049.
Choi CW, Kim BR, Ohn J, et al. The advantage of cyclosporine A and methotrexate rotational therapy in long-term systemic treatment for chronic plaque psoriasis in a real world practice. Ann Dermatol. 2017;29:55-60.
Callis Dufﬁn K, Yeung H, Takeshita J, et al. Patient satisfaction with treatments for moderate-to-severe plaque psoriasis in clinical practice. Br J Dermatol. 2014;170:672-680.
Spuls PI, Lecluse LL, Poulsen ML, et al. How good are clinical severity and outcome measures for psoriasis? quantitative evaluation in a systematic review. J Invest Dermatol. 2010;130:933-943.
Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826-850.
Bozek A, Reich A. The reliability of three psoriasis assessment tools: psoriasis area severity index, body surface area and physician global assessment. Adv Clin Exp Med. 2017;26:851-856.
Walsh JA, McFadden M, Woodcock J, et al. Product of the Physician Global Assessment and body surface area: a simple static measure of psoriasis severity in a longitudinal cohort. J Am Acad Dermatol. 2013;69:931-937.
Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis over 52 weeks: a phase III, randomized, controlled trial (ESTEEM 2). Br J Dermatol. 2015;173:1387-1399.
Duffin KC, Papp KA, Bagel J, et al. Evaluation of the Physician Global Assessment and body surface area composite tool for assessing psoriasis response to apremilast therapy: results from ESTEEM 1 and ESTEEM 2. J Drugs Dermatol. 2017;16:147-153.
Chiesa Fuxench ZC, Callis DK, Siegel M, et al. Validity of the Simple Measure for Assessing Psoriasis Activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol. 2015;73:868-870.
Walsh J. Comparative assessment of PASI and variations of PGA×BSA as measures of psoriasis severity in a clinical trial of moderate to severe psoriasis [poster 1830]. Presented at: Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA.
Gottlieb AB, Merola JF, Chen R, et al. Assessing clinical response and defining minimal disease activity in plaque psoriasis with the Physician Global Assessment and body surface area (PGA×BSA) composite tool: An analysis of apremilast phase 3 ESTEEM data. J Am Acad Dermatol. 2017;77:1178-1180.
Strober B, Bagel J, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate plaque psoriasis with lower BSA: week 16 results from the UNVEIL study. J Drugs Dermatol. 2017;16:801-808.
Bernhard J, Whitmore C, Guzzo C, et al. Evaluation of halobetasol propionate ointment in the treatment of plaque psoriasis: report on two double-blind, vehicle-controlled studies. J Am Acad Dermatol. 1991;25:1170-1174.
Katz HI, Gross E, Buxman M, et al. A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis. J Am Acad Dermatol. 1991;25:1175-1178.
Blum G, Yawalkar S. A comparative, multicenter, double blind trial of 0.05% halobetasol propionate ointment and 0.1% betamethasone valerate ointment in the treatment of patients with chronic, localized plaque psoriasis. J Am Acad Dermatol. 1991;25:1153-1156.
Goldberg B, Hartdegen R, Presbury D, et al. A double-blind, multicenter comparison of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in patients with chronic, localized plaque psoriasis. J Am Acad Dermatol. 1991;25:1145-1148.
Mensing H, Korsukewitz G, Yawalkar S. A double-blind, multicenter comparison between 0.05% halobetasol propionate ointment and 0.05% betamethasone dipropionate ointment in chronic plaque psoriasis. J Am Acad Dermatol. 1991;25:1149-1152.
Herz G, Blum G, Yawalkar S. Halobetasol propionate cream by day and halobetasol propionate ointment at night for the treatment of pediatric patients with chronic, localized psoriasis and atopic dermatitis. J Am Acad Dermatol. 1991;25:1166-1169.
Ultravate [package insert]. Jacksonville, FL: Ranbaxy; 2012.

Treatment success was rapid and achieved in more than 37% of participants by week 8, with significant improvements in psoriasis signs and symptoms (erythema, plaque elevation, and scaling) compared with vehicle. However, IGA does not consider BSA involvement, a key aspect of disease severity,^11,12 and improvements in psoriasis signs of erythema, plaque elevation, and scaling were only assessed at the target lesion. Recently, the product of the IGA and BSA involvement (IGA×BSA) has been proposed as a simple alternative for assessing response to therapy that has been consistently shown to be highly correlated with the psoriasis area and severity index.^13-19 Halobetasol propionate lotion 0.01% achieved a 50% reduction in IGA×BSA score by week 8. This efficacy compares well with results reported with apremilast in patients with moderate plaque psoriasis.²⁰

Achieving clinically meaningful outcomes is an important aspect of disease management, especially in psoriasis with its disease burden and detriment to quality of life. It has been suggested that achieving a 75% or greater reduction from baseline IGA×BSA score (IGA×BSA-75) is an appropriate clinical goal.²⁰ In our investigation, IGA×BSA-75 was achieved by 39% of participants treated with HP lotion by week 8, which again compares favorably with 35% of participants in the apremilast study who achieved IGA×BSA-75 at week 16.²⁰

Physicians continue to have long-term safety concerns with TCSs,^4,11,12 participants remain concerned about the risk for skin thinning,¹³ and product labelling restricts HP cream 0.05% consecutive use to 2 weeks. In clinical experience, HP cream 0.05% is well tolerated, with potential local AEs similar to those experienced with other superpotent TCSs. In short-term clinical trials, local AEs at the site of application were reported in up to 13% of patients^21-26; itching, burning, or stinging were the most common local AEs (reported in 4.4% of patients).²⁷

There were minimal safety concerns in our 2 studies using an 8-week, once-daily treatment regimen with HP lotion 0.01%. Local AEs at the application site were reported in less than 1% of participants. Baseline itching, dryness, and burning/stinging all improved with treatment.

CONCLUSION

Halobetasol propionate lotion 0.01% provides rapid improvement in disease severity. Halobetasol propionate lotion was consistently more effective than vehicle in achieving treatment success; reducing the BSA affected by the disease; reducing erythema, plaque elevation, and scaling at the target lesion; and improving IGA×BSA score over 8 weeks, which is a realistic time frame to see improvement in psoriasis with a topical steroid. There were minimal safety concerns with prolonged use. Halobetasol propionate lotion may provide an effective and reasonable treatment option in patients with moderate to severe plaque psoriasis.

Acknowledgment
We thank Brian Bulley, MSc (Konic Limited, United Kingdom), for assistance with the preparation of this article. Ortho Dermatologics funded Mr. Bulley’s activities pertaining to this article.

Safety and Efficacy of Halobetasol Propionate Lotion 0.01% in the Treatment of Moderate to Severe Plaque Psoriasis: A Pooled Analysis of 2 Phase 3 Studies

References

CONCLUSION

Pages

Recommended Reading