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Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results
Louis Bessette1, Jonathan Chan2, Andrew Chow3
1Centre de L'ostéoporose et de Rhumatologie de Québec (CORQ), Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO), Université de Laval, 100-1200 Avenue Germain-Des-Prés, Quebec, QC, G1V 3M7, Canada. louis.bessette@crchudequebec.ulaval.ca.
Introduction:
Upadacitinib (UPA), a selective, reversible, oral Janus kinase (JAK)-1 inhibitor, was approved in 2019 in Canada for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). This phase 4 prospective study aimed to characterise the effectiveness of UPA in the real-world population of patients with RA.
Methods:
Adults with RA who initiated treatment with once daily UPA (15 mg) and enrolled in the Canadian Real-Life post-marketing Observational Study assessing the Effectiveness of UPadacitinib for treating rheumatoid arthritis (CLOSE-UP) and who completed a 6-month assessment as of 28 February 2023 were included. The primary endpoint of the CLOSE-UP study is the proportion of patients achieving a Disease Activity Score-28 Joint Count C-reactive protein (DAS28-CRP) < 2.6 at 6 months. Data was collected at routine visits. Data analysed and summarised descriptively for the overall interim population and for subgroups based on prior therapy included remission or low disease activity, patient-reported outcomes (PROs), and adverse events.
Results:
A total of 392 patients were included in the interim analysis. Overall, 63.5% (191/301) of patients achieved a DAS28-CRP score < 2.6 at month 6, with similar rates observed for all subgroups analysed according to prior therapy including those with prior JAK inhibitor exposure (range 57.4-71.0%), and in patients who received UPA monotherapy (71.6% [48/67]). Early (month 3) and sustained improvements up to 6 months were observed for all PROs. The safety profile was consistent with previous reports.
Conclusion:
Real-world improvements in disease activity and PROs in response to UPA treatment were consistent with clinical trial data across a range of Canadian patients with prior therapy exposure and with UPA monotherapy, with an overall favourable benefit-risk profile.
Trial Registration:
NCT04574492.
Insights
Upadacitinib effectively reduced rheumatoid arthritis disease activity in a real-world Canadian study. Patients showed sustained improvements in symptoms and patient-reported outcomes, confirming clinical trial findings.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Upadacitinib (UPA), an oral Janus kinase (JAK)-1 inhibitor, is approved for rheumatoid arthritis (RA).
- Real-world effectiveness data is crucial for understanding treatment outcomes in diverse patient populations.
Purpose of the Study:
- To evaluate the real-world effectiveness of upadacitinib (UPA) in adult patients with moderately to severely active rheumatoid arthritis (RA) in Canada.
- To assess disease activity, patient-reported outcomes (PROs), and safety in a real-world setting.
Main Methods:
- Prospective, observational, phase 4 study (CLOSE-UP) including adult RA patients initiating UPA (15 mg once daily).
- Primary endpoint: proportion of patients achieving Disease Activity Score-28 Joint Count C-reactive protein (DAS28-CRP) < 2.6 at 6 months.
- Descriptive analysis of overall population and subgroups based on prior therapy, including PROs and adverse events.
Main Results:
- 63.5% of 392 patients achieved DAS28-CRP < 2.6 at 6 months.
- Similar efficacy observed across subgroups, including those with prior JAK inhibitor exposure and UPA monotherapy.
- Early and sustained improvements in PROs were noted, with a safety profile consistent with prior reports.
Conclusions:
- Real-world data demonstrates that upadacitinib improves disease activity and PROs in Canadian RA patients, consistent with clinical trial findings.
- The benefit-risk profile of UPA appears favorable in this real-world population, including those with prior therapy exposure.
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