0298: Effectiveness of Upadacitinib in Patients with Rheumatoid Arthritis in Canadian Real-World Practice: Interim Results from the CLOSE-UP Post-Marketing Observational Study

Derek Haaland¹, Jonathan Chan², Larissa Lisnevskaia³, Andrew Chow⁴, Tanya Girard⁵, Pierre-André Fournier⁵ and Louis Bessette⁶, ¹The Waterside Clinic, Oro Medonte, ON, Canada, ²University of British Columbia, Vancouver, BC, Canada, ³Oshawa Clinic, Oshawa, ON, Canada, ⁴Credit Valley Rheumatology, University of Toronto, Mississauga, ON, Canada, ⁵AbbVie, Saint-Laurent, QC, Canada, ⁶Centre de l'Ostoporose et de Rhumatologie de Québec, Québec, QC, Canada

Background/Purpose: Upadacitinib (UPA) is an oral, selective Janus kinase (JAK)- inhibitor that has been shown to be effective and well-tolerated in patients with rheumatoid arthritis (RA) in the Phase 3 SELECT clinical trials and was approved in Canada as a treatment option for RA in December 2019. The Canadian Real-Life post-marketing Observational Study assessing the Effectiveness of UPadacitinib for treating rheumatoid arthritis (CLOSE-UP) study initiated in 2020 aims to investigate the effectiveness of UPA across 390 Canadians including csDMARD, bDMARD and tsDMARD experienced real-world RA patients.

Methods: CLOSE-UP is an ongoing, prospective, multicenter, observational post-marketing study in adults with moderate-to-severe RA who are treated with UPA 15 mg once daily, with the decision to initiate UPA made prior to study participation. Participants are followed for 24 months following UPA initiation with data collected at routine clinic visits. The primary endpoint is the proportion of participants achieving a Disease Activity Score – 28 Joint Count, C-reactive protein (DAS28-CRP) < 2.6 at 6 months. Secondary endpoints include, pain score using a visual analog scale, fatigue (FACIT-F), physical function as measured by the Health Assessment Questionnaire (HAQ) and other assessments of disease activity including Clinical Disease Activity Index (CDAI) score. Per protocol, eligible subjects are grouped by prior/most recent exposure to: no b/tsDMARDs (bio-naïve); ≤2 bDMARDs but no tsDMARD (bio-experienced), and ≤1 bDMARD followed by a tsDMARD (tsDMARD-experienced). This descriptive interim analysis reports data for participants who had completed their 6-month visit by March 18, 2022. Data are presented as observed and summarized descriptively, with no statistical analyses conducted.

Results: Of the 183 participants included in this interim analysis, 89 (49%) were bio-naïve, 69 (38%) were bio-experienced and 25 (14%) were tsDMARD-experienced (Table 1). Overall, 63% of patients achieved a DAS28-CRP < 2.6 (primary endpoint; Figure 1) The proportion of participants achieving DAS28-CRP < 2.6 at the 6-month visit was similar between those receiving UPA monotherapy (62.2%, n=69/111) and those receiving UPA in combination with a csDMARD (63.9%, n=36/45). Physical function and patient reported outcomes including pain and fatigue improved over the first 6 months following UPA initiation. The safety profile of UPA was consistent with that seen in Phase 3 trials with no new safety signals (Table 2).

Conclusion: Consistent with clinical trial data, interim analysis of this real-world Canadian study showed that disease activity was reduced, and patient reported outcomes improved with an overall favorable benefit:risk profile for Canadian patients receiving UPA in the real-world setting.

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Bio-naïve: has not been previously exposed to any bDMARD or tsDMARD. Bio-experienced: has not been previously exposed to tsDMARD and has been previously exposed to ≤2 bDMARDs. tsDMARD-experienced: has been previously treated with one tsDMARD and ≤1 bDMARD prior to treatment with that tsDMARD. % is based on number of subjects with available data at each visit within the group. DAS28-CRP remission: score < 2.8; LDA: score ≤3.2. b, biologic; CRP, C-reactive protein; cs, conventional synthetic; DAS28, Disease Activity Score – 28 Joint Count; DMARD, disease modifying antirheumatic drug; LDA, low disease activity; ts, targeted synthetic.

Adverse Events (AEs) are coded using MedDRA Version 23.1. AEs of special interest include zoster, MACE, VTE, infections, serious infections, malignancy (excluding NMSC), death. MACE, Major Adverse Cardiac Event; NMSC, Non Melanoma Skin Cancer; SAE, Serious AE; VTE, Venous Thromboembolism.
Disclosures: D. Haaland, AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb(BMS), Eli Lilly, GlaxoSmithKlein(GSK), Janssen, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, Merck/MSD, UCB, Celgene, Adiga Life-Sciences, Can-Fite Biopharma, Regeneron, Gilead; J. Chan, AbbVie; L. Lisnevskaia, AbbVie; A. Chow, AbbVie, Celltrion, Pfizer, Novartis; T. Girard, AbbVie; P. Fournier, AbbVie; L. Bessette, AbbVie/Abbott, Amgen, Bristol-Myers Squibb(BMS), Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi-Genzyme, UCB, Gilead, Merck/MSD, Organon, Roche.