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Start RA treatment - Biologics or JAK-inhibitors?
Roberto Caporali1, Sabino Germinario1, Dorottya Kacsándi2
1Department of Clinical Sciences and Community Health, University of Milan and ASST G. Pini-CTO, Milan, Italy.
Abstract:
Janus Kinase inhibitors (JAKi) have been approved for the treatment of Rheumatoid Arthritis (RA) for several years. They are the first oral advanced treatment with efficacy similar to, if not greater than, biologic agents. Recently, concerns over their safety was raised by the results from Oral Surveillance trial suggesting that tofacitinib, one of the JAKi, was associated with higher cardiovascular adverse events and malignancies than TNF inhibitors (TNFi). Since then, regulatory authorities have added warnings to the labels of JAKi. On this purpose, whether rheumatologists should use JAKi as first line advance treatment has become a controversial topic. Some rheumatologists have argued that biologics should be first line advance treatment since there are extensive effectiveness and safety data. In addition, with the advent of biosimilar drugs, they are the most cost-effective treatment. On the other hand, JAKi are very efficacious and are generally safe apart from older and high-risk patients. When TNFi are contraindicated and in certain RA patients ,especially when an oral drug is preferable, JAKi have significant advantage providing patients are involved in the decision-making process.
Insights
Janus Kinase inhibitors (JAKi) offer oral advanced treatment for Rheumatoid Arthritis (RA) comparable to biologics. However, safety concerns necessitate careful patient selection and shared decision-making for optimal JAK inhibitor use.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Trials
Background:
- Janus Kinase inhibitors (JAKi) represent a significant advancement in oral therapy for Rheumatoid Arthritis (RA), demonstrating efficacy comparable to biologic agents.
- Recent safety data from the Oral Surveillance trial have raised concerns regarding cardiovascular adverse events and malignancies associated with tofacitinib, a JAK inhibitor.
Purpose of the Study:
- To evaluate the evolving role of JAK inhibitors in Rheumatoid Arthritis treatment.
- To address the controversy surrounding the use of JAK inhibitors as a first-line advanced treatment option.
- To inform clinical decision-making regarding the appropriate use of JAK inhibitors in RA management.
Main Methods:
- Review of clinical trial data, including the Oral Surveillance trial.
- Analysis of safety and efficacy profiles of JAK inhibitors versus TNF inhibitors (TNFi).
- Consideration of regulatory warnings and expert rheumatologist opinions.
Main Results:
- JAK inhibitors offer comparable efficacy to biologic agents but carry potential safety risks, particularly cardiovascular and malignancy concerns, as highlighted by recent trial data.
- Regulatory authorities have issued warnings, impacting the perception and use of JAK inhibitors.
- The cost-effectiveness of biologic agents, especially with biosimilar availability, presents an alternative perspective.
Conclusions:
- The use of JAK inhibitors in RA is a complex decision, balancing efficacy with safety concerns, especially in high-risk patients.
- Shared decision-making between clinicians and patients is crucial for appropriate JAK inhibitor selection.
- JAK inhibitors remain a valuable option for specific RA patient populations, particularly when oral administration is preferred or TNFi are contraindicated.
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