Emerging Insights: The Impact of Real-world Evidence on Rheumatoid Arthritis. Latest Evidence from Janus Kinase (JAK) Inhibitors
Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, is approved as monotherapy or in combination with methotrexate for treating adults with moderate-to-severe active rheumatoid arthritis (RA) and provides improvements in clinical signs, symptoms and patient-reported outcomes. In sever...
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| Format: | Article |
| Language: | English |
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World Scientific Publishing
2024-01-01
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| Series: | Journal of Clinical Rheumatology and Immunology |
| Online Access: | https://www.worldscientific.com/doi/10.1142/S2661341724740067 |
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| Summary: | Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, is approved as monotherapy or in combination with methotrexate for treating adults with moderate-to-severe active rheumatoid arthritis (RA) and provides improvements in clinical signs, symptoms and patient-reported outcomes. In several pivotal Phase II and III RA trials, up to seven years of baricitinib treatment was well tolerated and provided rapid and sustained efficacy. These findings have been substantiated in the context of “real-world” settings. Real-world evidence (RWE) helps health authorities and healthcare providers gain further insights regarding treatment effectiveness and safety in real-life settings as they focus on heterogenous patient populations (who may be older, more treatment refractory, and with more comorbid conditions than clinical trial populations). RWE permits the identification of associations between treatment and rare AEs and also helps the medical community to better understand treatment patterns, such as line of therapy utilisation, and to define risks associated with lower effectiveness or poorer drug survival. This talk will explore the clinical and real-world data investigating the benefit: risk profile of baricitinib, confirming that the improved disease activity and physical function of patients with RA treated with this JAK inhibitor observed in clinical trials is translated into effectiveness in real-world clinical practice, with a low rate of discontinuations. The post-marketing Phase IIIb/IV trial Oral Rheumatoid Arthritis Trial (ORAL) Surveillance identified venous thrombotic events (VTE), major adverse cardiovascular events (MACE), and malignancy as potential safety signals associated with tofacitinib, a JAK1,3 inhibitor, in comparison to biologic anti-TNFs. In the case of baricitinib, while some, but not all, RWE points to potential VTE risks, data regarding MACE have been generally reassuring. Several real world and registry studies indicate that drug survival is consistently higher with baricitinib than with biological anti-cytokine drugs. In the case of patients with inadequate response to a first anti-TNF, EULAR recommendations for treatment change include cycling within drug class or switching the mode of action of advanced therapy. However, clinical trials and RWE confirm that switching to an advanced therapy of a different mode of action after anti-TNF failure is more effective and associated with lower rates of withdrawal than cycling to a different anti-TNF. In the case of patients with inadequate response to a first JAK inhibitor, RWE indicates that patients who cycle to another JAK inhibitor are more likely to achieve a good clinical response and have higher drug survival than patients switched to bDMARDs. |
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| ISSN: | 2661-3417 2661-3425 |