Treatment of pemphigus

Abstract

The present disclosure provides methods of treating with a BTK inhibitor a blistering disease, in particular pemphigus vulgaris or pemphigus folliaceous in a mammal, use of a BTK inhibitor as a replacement therapy for corticosteroid therapy for diseases treatable with a corticosteroid, such as autoimmune or inflammatory disease and in particular where corticosteroids are used as first or second line therapy, and pharmaceutical formulations comprising the same.

Description

technical field [0001] This application claims priority to US Provisional Patent Application Serial No. 62 / 093,891, filed December 18, 2014; the contents of which are incorporated herein by reference. [0002] The present invention provides methods of treating blistering diseases, especially pemphigus vulgaris or pemphigus foliaceous, with BTK inhibitors in mammals; BTK inhibitors as use in diseases treatable with corticosteroids Use in alternative therapy of corticosteroid therapy (such as autoimmune or inflammatory diseases and especially diseases in which corticosteroids are used as first-line or second-line therapy); and pharmaceutical formulations comprising the same. Background technique [0003] Pemphigus vulgaris (PV) is a tissue-specific autoimmune blistering disease of the skin and mucous membranes in humans (Scully C, Challacombe S.J. Pemphigus vulgaris: Pathogenesis, oral manifestations and control (Pemphigus vulgaris: update on etiopathogenesis, oral manifestat...

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[0007] Disadvantages of the above regimens are that IVIG therapy is expensive and has adverse effects such as headache, back pain, flushing, fever, nausea and vomiting, anaphylaxis, aseptic meningitis, kidney failure, and high blood pressure (see product label) , and clinical response to rituximab was significantly delayed (maximum effect achieved at 8-12 weeks, see Lundardon and Payne AS G Ital Dermatol Venereol "2012; 147(3):269-276), thus requiring corticosteroid therapy lasting several months, and moreover, the durability of response as measured by anti-keratinocytes varies from no relapse to multiple relapses

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