Clinical and immunological outcomes of high- and low-dose rituximab treatments in patients with pemphigus: a randomized, comparative, observer-blinded study

Summary Background Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose. Objectives To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab. Methods...

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Bibliographic Details
Published in:British journal of dermatology (1951) 2014-06, Vol.170 (6), p.1341-1349
Main Authors: Kanwar, A.J., Vinay, K., Sawatkar, G.U., Dogra, S., Minz, R.W., Shear, N.H., Koga, H., Ishii, N., Hashimoto, T.
Format: Article
Language:English
Subjects:
Adolescent
Adrenal Cortex Hormones - therapeutic use
Adult
Aged
Antigens, CD19 - metabolism
B-Lymphocytes - immunology
Biological and medical sciences
Bullous diseases of the skin
Dermatologic Agents - administration & dosage
Dermatologic Agents - adverse effects
Dermatology
Desmoglein 1 - metabolism
Desmoglein 3 - metabolism
Drug Administration Schedule
Enzyme-Linked Immunosorbent Assay
Female
Humans
Lymphopenia - chemically induced
Lymphopenia - immunology
Male
Medical sciences
Middle Aged
Pemphigus - drug therapy
Pemphigus - immunology
Pilot Projects
Recurrence
Rituximab - administration & dosage
Rituximab - adverse effects
Treatment Outcome
Young Adult
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Summary:Summary Background Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose. Objectives To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2 × 1000 mg) vs. a low dose (2 × 500 mg) of rituximab. Methods This was a randomized, observer‐blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000 mg rituximab or 500 mg rituximab, and were followed up for 48 weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme‐linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals. Results There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2 × 1000 mg group than in 2 × 500 mg group (P = 0·049). Patients in the 2 × 500 mg group received a significantly higher cumulative dose of azathioprine (P = 0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2 × 1000 mg group only. B cell repopulation occurred earlier in the 2 × 500 mg group by 8 weeks. Conclusions A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high‐dose (2 × 1000 mg) rituximab. What's already known about this topic? There is no agreement on the optimum dose of rituximab to be used in treating patients with pemphigus. A single study has reported low‐dose rituximab (2 × 500 mg) to be effective in patients with pemphigus. What does this study add? A few clinical (relapse rate, adjuvant requirement) and immunological (fall in desmoglein indices, CD19 cell repopulation) outcomes suggest improved outcomes in patients with pemphigus receiving 2 × 1000 mg rituximab compared with a dose of 2 × 500 mg.
ISSN:0007-0963
1365-2133
DOI:10.1111/bjd.12972