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Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program
Xavier Mariette1, Connie Chen2, Pinaki Biswas2
1Université Paris-Sud, Assistance publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Le Kremlin Bicêtre, France.
Tofacitinib treatment for rheumatoid arthritis showed stable lymphoma rates over time. Lymphoma characteristics were typical for RA patients, with no significant baseline differences observed.
Area of Science:
- Rheumatology
- Oncology
- Pharmacology
Background:
- Tofacitinib is an oral Janus kinase (JAK) inhibitor used for rheumatoid arthritis (RA).
- Understanding the risk of lymphoma is crucial for patients treated with JAK inhibitors.
Purpose of the Study:
- To characterize lymphoma events within the tofacitinib RA clinical development program.
- To assess lymphoma incidence rates and identify potential risk factors.
Main Methods:
- Analysis of lymphoma events from 19 tofacitinib studies (Phase I-III and long-term extension) up to March 2015.
- Calculation of incidence rates (IR) and standardized incidence ratios (SIR) compared to the SEER database.
- Descriptive case-matched control analysis to identify risk factors.
Main Results:
- 19 lymphomas occurred in 6,194 patients (19,406 patient-years), with an IR of 0.10 per 100 patient-years.
- The age- and sex-adjusted SIR for lymphoma was 2.62 compared to the general population.
- Lymphoma characteristics were typical for RA patients; higher corticosteroid use and certain autoantibodies were noted in cases versus controls.
Conclusions:
- Lymphoma rates remained stable over time during the tofacitinib RA clinical development program.
- Minimal differences in baseline characteristics were observed between patients with and without lymphoma.
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