The Off-Label Use of Rituximab for the Management of Inflammatory Disorders: American University of Beirut Medical Center Experience

Dana HARB,2 Hiba MOUKADEM,2 Rabih NAYFE,1 Ali MEHDI,3 Abdel Fattah MASRI,2 Ziad SALEM,2 Ali TAHER,2 Imad UTHMAN2

1Department of Internal Medicine, Akron General Medical Center, Copley/OH, USA
2Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
3Department of Internal Medicine, The Cleveland Clinic Foundation, Cleveland/OH, USA

Keywords: Autoimmune disease; biologic therapy; inflammatory disorder; off-label; rituximab.

Abstract

Objectives: This study aims to evaluate the efficacy of off-label use of rituximab with possible side effects.
Patients and methods: Records of the 44 American University of Beirut Medical Center pharmacies were searched for patients who used rituximab over the past 4.5 years, and data on rituximab dosage, protocol and side effects were documented. The majority of patients had systemic lupus erythematosus. Autoimmune thrombocytopenic purpura, antiphospholipid syndrome, Sjögren's syndrome, Wegener’s granulomatosis, autoimmune hemolytic anemia, dermatomyositis, and pemphigus vulgaris were also reported. Outcome measures were improvement in signs and symptoms during a follow-up period of two years.
Results: Twenty-nine out of the 44 patients had complete response without relapse. Of those, 12 patients were in remission after the first cycle. Of the systemic lupus erythematosus cases, 12 had complete response without relapse; of which, five patients had remission after the first cycle. No significant toxicities were noted.
Conclusion: The off-label use of rituximab in various inflammatory diseases showed improvement in symptoms with no significant side effects in patients who have failed previous treatment with multiple conventional regimens.

Conflict of Interest

The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

Financial Disclosure

The authors received no financial support for the research and/or authorship of this article.