A randomized placebo-controlled single-center pilot study of the safety and efficacy of apremilast in subjects with moderate-to-severe alopecia areata

Mikhaylov, Daniela; Pavel, Ana B.; Yao, Christopher J.; Kimmel, Grace W.; Nia, John K; Hashim, Peter W.; Vekaria, Anjali S.; Taliercio, Mark; Singer, Giselle; Karalekas, Rachel; Baum, Danielle; Mansouri, Yasaman; Lebwohl, Mark; Guttman‐Yassky, Emma

doi:10.1007/s00403-018-1876-y

Cited by 49 publications

(62 citation statements)

References 39 publications

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“…[910] Mikhaylov et al . [7] evaluated clinical response (percent change in SALT score) at weeks 24 and 48; however, we show an earlier response without enough surveillance time. Their baseline mean SALT score (88) is also higher than in our case series (two patients associated moderate psoriasis and atopic dermatitis also getting benefit from apremilast treatment).…”

Section: Discussionmentioning

confidence: 64%

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Apremilast in refractory alopecia areata

Estébanez

Martín

et al. 2019

Int J Trichol

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Alopecia areata (AA) is a common disease characterized by nonscarring hair loss. There are no satisfactory therapies for extensive cases. Systemic immune suppressants are usually used despite their nonspecific actions and often associated side effects. Apremilast is an oral, small-molecule, inhibitor of phosphodiesterase 4 approved for the treatment of psoriasis and psoriatic arthritis. Its use in AA has shown variable results. Whereas a recent reduced clinical trial concluded a lack of efficacity, several case reports demonstrate a significant improvement. We report four cases of extensive AA successfully treated with apremilast.

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Section: Discussionmentioning

confidence: 64%

“…Patients with both conditions can get benefit from apremilast treatment, as presented in our last two cases. Some recent studies and clinical trials showed a lack of efficacy of apremilast in severe cases of AA,[78] whereas other case reports demonstrated considerable good responses. [910] Mikhaylov et al .…”

Section: Discussionmentioning

confidence: 99%

Apremilast in refractory alopecia areata

Estébanez

Martín

et al. 2019

Int J Trichol

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“…[134][135][136] The question of whether IL-23 antagonism, such as through ustekinumab therapy, can reproducibly promote hair regrowth in patients with AA awaits systemic analysis. 137 Only a mild therapeutic effect was observed after treatment with IL-17, 138 whereas the phosphodiesterase 4 antagonist apremilast had insufficient therapeutic effects in patients with AA 139 and in the humanized AA mouse model, 140 in which apremilast nevertheless inhibited experimental induction of AA lesions in vivo. Collectively, in addition to targeting IFN-g-and JAK/ STAT-mediated signaling in patients with AA, several additional pathways that also deserve therapeutic targeting, at least in selected AA subpopulations/subtypes, deserve systematic exploration.…”

Section: Novel Therapeutic Intervention Strategiesmentioning

confidence: 99%

Frontiers in alopecia areata pathobiology research

Gilhar

Laufer-Britva

Keren

et al. 2019

Journal of Allergy and Clinical Immunology

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This current review explores selected and as yet insufficiently investigated frontiers in current alopecia areata (AA) pathobiology research, with an emphasis on potential ''new'' players in AA pathobiology that deserve more systematic exploration and therapeutic targeting. Indeed, new evidence suggests that CD8 1 T cells, which have long been thought to be the central players in AA pathobiology, are not the only drivers of disease. Instead, subsets of natural killer (NK) and so-called ''unconventional'' T cells (invariant NK T cells, gd T cells, classic NK cells, and type 1 innate lymphoid cells), all of which can produce large amounts of IFN-g, might also drive AA pathobiology independent of classical, autoantigen-dependent CD8 1 T-cell functions. Another important new frontier is the role of regulatory lymphocyte subsets, such as regulatory T cells, gd regulatory T cells, NKT10 cells, and perifollicular mast cells, in maintaining physiologic hair follicle immune privilege (IP); the extent to which these functions are defective in patients with AA; and how this IP-protective role could be restored therapeutically in patients with established AA. Broadening our AA research horizon along the lines suggested above promises not only to open the door to innovative and even more effective immunotherapy strategies for AA but will also likely be relevant for other autoimmune disorders in which pathobiology, ectopic MHC class I expression, and IP collapse play an important role.

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“…R. Laufer Britva,1,2,3 A. Keren, 1,2 R. Paus4,5 and A. Gilhar iD 1,Skin Research Laboratory, Rappaport Faculty of Medicine, Technion -Israel Institute of Technology, Haifa, Israel; 2 Rambam Health Care Campus, Haifa, Israel; 3 Department of Dermatology, Rambam Health Care Campus, Haifa, Israel; 4 Dr. Philipp Frost Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL,, U.S.A, and 5 Centre for Dermatology Research, University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, U.K. Correspondence: Amos Gilhar E-mail: doritg2000@gmail.com…”

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confidence: 99%

Apremilast and tofacitinib exert differential effects in the humanized mouse model of alopecia areata

et al. 2019

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skin diseases reflected in the Cochrane Database of Systematic Reviews, 5 where psoriasis and decubitus ulcer were overrepresented diseases in terms of research, whereas urticaria and bacterial skin infections were underrepresented. A strength of this study is the interrelationship made between two large national datasets, from studies designed to be representative both of outpatient consultations and research activity in Spain, 3,4 and data from the GBDS. Among the limitations are that this study is restricted to 14 groups of diseases and only outpatient consultations, which may not be representative of all skin conditions, and that the unweighted number of publications might not be a good measure of research activity. Another limitation is that the periods of the three studies did not match exactly, which could affect the comparability of the data. However, burden of skin diseases and frequency of consultations are unlikely to differ from those in the period of the MaIND study. Our data suggest that melanoma might be overrepresented in research, whereas acne and viral infections could be underrepresented according to the demand for consultations and the disease burden. Research in psoriasis and dermatitis is proportional to the disease burden and demand for consultations whereas research in NMSC is scarce according to demand for consultations but disproportionate according to disease burden. Research priorities, should be conscious decisions that take into account quantitative data, such as the burden of skin conditions and the demand for clinical assistance in order to sort the need for resources, and qualitative research, such as James Lind Alliance Prioritization exercises, could be useful to select the main research questions within each topic.

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A randomized placebo-controlled single-center pilot study of the safety and efficacy of apremilast in subjects with moderate-to-severe alopecia areata

Cited by 49 publications

References 39 publications

Apremilast in refractory alopecia areata

Apremilast in refractory alopecia areata

Frontiers in alopecia areata pathobiology research

Apremilast and tofacitinib exert differential effects in the humanized mouse model of alopecia areata

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