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Clinical scenarios-based guide for tofacitinib in rheumatoid arthritis
Mahta Mortezavi1, Eduardo F Mysler2
1Pfizer Inc, 66 Hudson Boulevard, New York, NY 10001, USA.
Abstract:
Tofacitinib was the first Janus kinase inhibitor to be approved for the treatment of rheumatoid arthritis (RA), and there is a large body of data to inform the efficacy and safety of this drug for patients at different places in their treatment journeys and with diverse demographics and characteristics. Here, we summarize tofacitinib clinical efficacy and safety data from some clinical trials, post hoc analyses, and real-world studies, which provide evidence of the efficacy of tofacitinib in treating patients with RA at various stages of their treatment journeys, and with differentiating baseline characteristics, such as age, gender, race, and body mass index. In addition, we review the safety data available from different patient subpopulations in the tofacitinib clinical development program, real-world data, and findings from the ORAL Surveillance post-marketing safety study that included patients aged ⩾50 years with pre-existing cardiovascular risk factors. The available efficacy and safety data in these subpopulations can enable better discussions between clinicians and patients to guide informed decision-making and individualized patient care.
Insights
Tofacitinib demonstrates consistent efficacy and safety in rheumatoid arthritis (RA) patients across diverse populations and treatment stages. Real-world data and clinical trials support its use for individualized patient care.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Medicine
Background:
- Tofacitinib is the first Janus kinase (JAK) inhibitor approved for rheumatoid arthritis (RA).
- Extensive data exist on its efficacy and safety in various patient groups and treatment phases.
Purpose of the Study:
- To summarize clinical efficacy and safety data of tofacitinib in rheumatoid arthritis.
- To evaluate data across diverse demographics, treatment stages, and specific subpopulations.
Main Methods:
- Review of clinical trials, post hoc analyses, and real-world studies.
- Inclusion of data from the ORAL Surveillance post-marketing safety study.
- Analysis of safety in patient subpopulations, including older adults with cardiovascular risk factors.
Main Results:
- Tofacitinib shows efficacy in RA patients at various treatment stages and with different baseline characteristics (age, gender, race, BMI).
- Safety data are available for diverse subpopulations, informing risk-benefit assessments.
- The ORAL Surveillance study provides crucial safety insights for specific patient groups.
Conclusions:
- Tofacitinib efficacy and safety data support its use in varied RA patient populations.
- Evidence enables informed decision-making and personalized treatment strategies.
- Data facilitate better clinician-patient discussions for individualized care in RA management.
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