An open label randomized placebo-controlled study of apremilast in common immune mediated papulosquamous hair and pigmentary dermatoses

Authors

  • B. Rekha Rani Department of Dermatology, Venerology and Leprosy, MIMS, Nellimarla, Andhra Pradesh, India
  • M. Arun Kumar Department of Dermatology, Venerology and Leprosy, MIMS, Nellimarla, Andhra Pradesh, India
  • K. Sudhir Babu Consultant Pathologist, Vijaya Diagnostic Center, Visakhapatnam, Andhra Pradesh, India
  • T. Narayana Rao Department of Dermatology, Venerology and Leprosy, Gayatri Vidya Parishad, Vizag, Andhra Pradesh, India

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20220495

Keywords:

Apremilast, Papulosquamous, Alopecia, Pigmentary dermatoses

Abstract

Background: Apremilast is a novel PDE4 inhibitor which interferes with several key processes of inflammation. The objective of this study was to determine the efficacy and safety profile of apremilast in common immune mediated papulosquamous, hair and pigmentary dermatoses.  

Methods: It was a prospective, open labelled, randomised, placebo-controlled study done over a period of 18 months. A total number of 100 patients were enrolled in which 50 were cases and 50 were controls. Psoriasis, lichen planus, alopecia areata and vitiligo cases were randomly enrolled at our OPD. Apremilast starter pack was given initially for 1 week followed by 30 mg twice daily for four months. All patients were followed up every 4 weeks for 16 weeks. Photographic documentation, assessment of PASI, LPSI, SALT, VASI and adverse effects were noted at baseline and at each visit. Patients were followed up for 6 months after the treatment for any recurrences.

Results: Mean percentage improvement of PASI score in psoriasis group, LPSI score in LP group, SALT score in alopecia areata group and VASI score in vitiligo group was 62%, 71%, 24.4% and 15% respectively. Apremilast was more effective in psoriasis and lichen planus groups.

Conclusions: Apremilast is an effective treatment option for mild to moderate psoriasis and lichen planus but was found to be less efficacious in alopecia areata and vitiligo, according to our study. Apremilast was well tolerated with minimal side effects which were manageable with symptomatic treatment.

References

Wang WM, Guo L, Jin HZ. Role of B cells in immune-mediated dermatoses. Mol Immunol. 2020;126:95-100.

Fox BJ, Odom RB. Papulosquamous diseases: a review. J Am Acad Dermatol. 1985;12(4):597-624.

Burden DA, Kirby B. Rook’s textbook of dermatology. 9th ed. UK: Blackwell publishing; 2010: 35.

Rao R, Sacchidanand S. IADVL Textbook of Dermatology. 4th ed. India: Bhalani; 2013: 1090-1093.

Huff SB, Gottwald LD. Repigmentation of Tenacious Vitiligo on Apremilast. Case Rep Dermatol Med. 2017;2017:2386234.

Bubna AK. Apremilast: A Dermatologic Perspective. Bubna AK. Apremilast: A dermatologic perspective. Indian J Drugs Dermatol. 2016;2:75-82.

Dogra S, Mahajan R. Psoriasis: Epidemiology, clinical features, co-morbidities, and clinical scoring. Indian Dermatol Online J. 2016;7(6):471-80.

Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012;380(9843):738-46.

Paul C, Cather J, Gooderham M, Poulin Y, Mrowietz U, Ferrandiz C, 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(6):1387-99.

Shah BJ, Mistry D, Chaudhary N, Shah S. Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis. Indian Dermatol Online J. 2020;11(1):51-7.

Vujic I, Herman R, Sanlorenzo M, Posch C, Monshi B, Rappersberger K, et al. Apremilast in psoriasis - a prospective real-world study. J Eur Acad Dermatol Venereol. 2018;32(2):254-9.

Ohata C, Ohyama B, Kuwahara F, Katayama E, Nakama T. Real-world data on the efficacy and safety of apremilast in Japanese patients with plaque psoriasis. J Dermatolog Treat. 2019;30(4):383-6.

Paul J, Foss CE, Hirano SA, Cunningham TD, Pariser DM. An open-label pilot study of apremilast for the treatment of moderate to severe lichen planus: a case series. J Am Acad Dermatol. 2013;68(2):255-61.

Mikhaylov D, Pavel A, Yao C, Kimmel G, Nia J, Hashim P, et al. A randomized placebo-controlled single-center pilot study of the safety and efficacy of apremilast in subjects with moderate-to-severe alopecia areata. Arch Dermatol Res. 2019;311(1):29-36.

Liu LY, King BA. Lack of efficacy of apremilast in 9 patients with severe alopecia areata. J Am Acad Dermatol. 2017;77(4):773-4.

Majid I, Imran S, Batool S. Apremilast is effective in controlling the progression of adult vitiligo: A case series. Dermatol Ther. 2019;32(4):12923.

Papadavid E, Rompoti N, Theodoropoulos K, Kokkalis G, Rigopoulos D. Real-world data on the efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2018;32(7):1173-9.

Downloads

Published

2022-02-24

Issue

Section

Original Research Articles