Shifting Focus in the Therapeutics of Immunobullous Disease

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Abstract

Therapeutics of autoimmune bullous disease has seen a major shift of focus from more global immunosuppression to targeted immunotherapy. Anti CD 20 monoclonal antibody Rituximab revolutionized the therapeutics of autoimmune bullous disease particularly pemphigus. Though it is still being practiced off-label, evidences in the form of RCT and meta analysis are now available. Other novel anti CD 20 monoclonal antibodies like ofatumumab, veltuzumab, and ocrelizumab, tositumomab or obinutuzumab/GA101 may add to the therapeutic options in coming days. Beyond anti CD 20 monoclonal antibodies other options that show promise at least in select scenario are omalizumab, TNF inhibitors plasmapheresis and intravenous immunoglobulin. The present article will discuss the role of rituximab and other newer therapeutics in the treatment of autoimmune blistering disease, especially pemphigus and suggests their positions in the therapeutic ladder.

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Most cited references 71

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Consensus statement on definitions of disease, end points, and therapeutic response for pemphigus.

Juana Alba Luis-Díaz, Victoria P Werth, Dedee Murrell … (2008)

Our scientific knowledge of pemphigus has dramatically progressed in recent years. However, despite the availability of various therapeutic options for the treatment of inflammatory diseases, only a few multicenter controlled trials have helped to define effective therapies in pemphigus. A major obstacle in comparing therapeutic outcomes between centers is the lack of generally accepted definitions and measurements for the clinical evaluation of patients with pemphigus. Common terms and end points of pemphigus are needed so that experts in the field can accurately measure and assess disease extent, activity, severity, and therapeutic response, and thus facilitate and advance clinical trials. This consensus statement from the International Pemphigus Committee represents 2 years of collaborative efforts to attain mutually acceptable common definitions for pemphigus. These should assist in development of consistent reporting of outcomes in future studies.

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Tolerability and safety of rituximab (MabThera).

Eva Kimby (2005)

Rituximab, a human/mouse chimeric anti-CD20 antibody, has become part of standard therapy for patients with CD20-expressing B-cell lymphoma, and is currently under investigation for other indications including autoimmune diseases, in particular rheumatoid arthritis (RA). Its characteristic tolerability profile was established soon after clinical testing began and compares favourably with chemotherapy. The majority of patients experience mild to moderate infusion-related reactions (IRRs) during the first administration of rituximab, but the incidence decreases markedly with subsequent infusions. Current data suggest that the type of adverse events in patients with RA are similar to those in lymphoma, but that adverse events related to the rituximab infusions are less severe and less frequent. Rituximab induces a rapid depletion of normal CD20-expressing B-cells in the peripheral blood, and levels remain low or undetectable for 2-6 months before returning to pretreatment levels, generally within 12 months. Serum immunoglobulin levels remain largely stable, although a reduction in IgM has been described. T-cells are unaffected by rituximab and consequently opportunistic infections rarely occur in association with rituximab therapy. When used in combination with a variety of chemotherapeutic regimens, rituximab does not add to the toxicity of chemotherapy, with the exception of a higher rate of neutropenia. However, this does not translate into a higher infection rate. Over 540,000 patients worldwide have now received rituximab and serious adverse reactions have occurred in a small minority of patients, but for the great majority of patients, rituximab is safe and well tolerated.

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A single cycle of rituximab for the treatment of severe pemphigus.

Michael Hertl, Nathalie Franck, Ralf Müller-Xing … (2007)

The combination of multiple cycles of rituximab and intravenous immune globulins has been reported to be effective in patients with severe pemphigus. The aim of this study was to assess the efficacy of a single cycle of rituximab in severe types of pemphigus. We studied 21 patients with pemphigus whose disease had not responded to an 8-week course of 1.5 mg of prednisone per kilogram of body weight per day (corticosteroid-refractory disease), who had had at least two relapses despite doses of prednisone higher than 20 mg per day (corticosteroid-dependent disease), or who had severe contraindications to corticosteroids. The patients were treated with four weekly infusions of 375 mg of rituximab per square meter of body-surface area. The primary end point was complete remission 3 months after the end of rituximab treatment; complete remission was defined as epithelialization of all skin and mucosal lesions. Eighteen of 21 patients (86%; 95% confidence interval, 64 to 97%) had a complete remission at 3 months. The disease relapsed in nine patients after a mean of 18.9+/-7.9 months. After a median follow-up of 34 months, 18 patients (86%) were free of disease, including 8 who were not receiving corticosteroids; the mean prednisone dose decreased from 94.0+/-10.2 to 12.0+/-7.5 mg per day (P=0.04) in patients with corticosteroid-refractory disease and from 29.1+/-12.4 to 10.9+/-16.5 mg per day (P=0.007) in patients with corticosteroid-dependent disease. Pyelonephritis developed in one patient 12 months after rituximab treatment, and one patient died of septicemia 18 months after rituximab treatment. These patients had a profound decrease in the number of circulating B lymphocytes but normal serum levels of IgG. A single cycle of rituximab is an effective treatment for pemphigus. Because of its potentially severe side effects, its use should be limited to the most severe types of the disease. (ClinicalTrials.gov number, NCT00213512 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

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Author and article information

Journal

Journal ID (nlm-ta): Indian J Dermatol

Journal ID (iso-abbrev): Indian J Dermatol

Journal ID (publisher-id): IJD

Title: Indian Journal of Dermatology

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 0019-5154

ISSN (Electronic): 1998-3611

Publication date (Print): May-Jun 2017

Volume: 62

Issue: 3

Pages: 282-290

Affiliations

[1] From the Associate Professor, Calcutta National Medical College, Kolkata, West Bengal, India

[1 ] Senior Resident, Calcutta National Medical College, Kolkata, West Bengal, India

[2 ] Senior Resident, KPC Medical College, Kolkata, West Bengal, India

Author notes

Address for correspondence: Dr. Abhishek De, Calcutta National Medical College, Kolkata, West Bengal, India. E-mail: dr_abhishek_de@ 123456yahoo.co.in

Article

Publisher ID: IJD-62-282

DOI: 10.4103/ijd.IJD_199_17

PMC ID: 5448263

PubMed ID: 28584371

SO-VID: 4733a54d-67c2-41d0-bb4e-a7f77f1a7b3f

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Shifting Focus in the Therapeutics of Immunobullous Disease

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Most cited references 71

Consensus statement on definitions of disease, end points, and therapeutic response for pemphigus.

Tolerability and safety of rituximab (MabThera).

A single cycle of rituximab for the treatment of severe pemphigus.

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