PMID- 35678771 OWN - NLM STAT- MEDLINE DCOM- 20230213 LR - 20230415 IS - 2151-4658 (Electronic) IS - 2151-464X (Print) IS - 2151-464X (Linking) VI - 75 IP - 2 DP - 2023 Feb TI - Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study. PG - 240-251 LID - 10.1002/acr.24966 [doi] AB - OBJECTIVE: The Canadian Tofacitinib for Rheumatoid Arthritis Observational (CANTORAL) is the first Canadian prospective, observational study assessing tofacitinib. The objective was to assess effectiveness and safety for moderate to severe rheumatoid arthritis (RA). Coprimary and secondary outcomes are reported from an interim analysis. METHODS: Patients initiating tofacitinib from October 2017 to July 2020 were enrolled from 45 Canadian sites. Coprimary outcomes (month 6) included the Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA) and remission. Secondary outcomes (to month 18) included the CDAI and the 4-variable Disease Activity Score in 28 joints (DAS28) using the erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP) level to define LDA and remission; the proportions of patients achieving mild pain (visual analog scale <20 mm), and moderate (>/=30%) and substantial (>/=50%) pain improvements; and the proportions of patients achieving a Health Assessment Questionnaire disability index (HAQ DI) score greater or equal to normative values (/=0.22). Safety was assessed to month 36. RESULTS: Of 504 patients initiating tofacitinib, 44.4% received concomitant methotrexate. At month 6, 52.9% and 15.4% of patients were in CDAI-defined LDA and remission, respectively; a similar proportion of patients achieved outcomes by month 3 (first post-baseline assessment). By month 3, 27.2% and 41.7% of patients, respectively, were in DAS28-ESR-defined LDA and DAS28-CRP <3.2; 14.7% and 25.8% achieved DAS28-ESR remission and DAS28-CRP <2.6. By month 3, mild pain and moderate and substantial pain improvements occurred in 29.6%, 55.6%, and 42.9% of patients, respectively; 19.9% and 53.7% of patients achieved a HAQ DI score greater than or equal to normative values and a HAQ DI score greater than or equal to MCID, respectively. Outcomes were generally maintained to month 18. Incidence rates (events per 100 patient-years) for treatment-emergent adverse events (AEs), serious AEs, and discontinuations due to AEs were 126.8, 11.9, and 14.5, respectively, and AEs of special interest were infrequent. CONCLUSION: Tofacitinib was associated with early and sustained improvement in RA signs and symptoms in real-world patients. Effectiveness and safety were consistent with the established tofacitinib clinical profile. CI - (c) 2022 Pfizer Inc. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology. FAU - Haraoui, Boulos AU - Haraoui B AD - Institut de Rhumatologie de Montreal, Montreal, Quebec, Canada. FAU - Khraishi, Majed AU - Khraishi M AD - Memorial University of Newfoundland, St. John's, Newfoundland, Canada. FAU - Choquette, Denis AU - Choquette D AD - Institut de Rhumatologie de Montreal, Montreal, Quebec, Canada. FAU - Lisnevskaia, Larissa AU - Lisnevskaia L AD - Oshawa Clinic, Oshawa, Ontario, Canada. FAU - Teo, Michelle AU - Teo M AD - University of British Columbia, Penticton, British Columbia, Canada. FAU - Kinch, Cassandra AU - Kinch C AD - Pfizer Canada ULC, Kirkland, Quebec, Canada. FAU - Galos, Corina AU - Galos C AD - Pfizer Canada ULC, Kirkland, Quebec, Canada. FAU - Roy, Patrice AU - Roy P AD - Pfizer Canada ULC, Kirkland, Quebec, Canada. FAU - Gruben, David AU - Gruben D AD - Pfizer Inc, Groton, Connecticut. FAU - Woolcott, John C AU - Woolcott JC AD - Pfizer Inc, Collegeville, Pennsylvania. FAU - Vaillancourt, Julie AU - Vaillancourt J AD - JSS Medical Research, Montreal, Quebec, Canada. FAU - Sampalis, John S AU - Sampalis JS AD - JSS Medical Research and University of McGill, Montreal, Quebec, Canada. FAU - Keystone, Edward C AU - Keystone EC AD - University of Toronto, Toronto, Ontario, Canada. CN - Canadian Tofacitinib for Rheumatoid Arthritis Observational Investigators LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20221010 PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - 87LA6FU830 (tofacitinib) RN - 0 (Pyrroles) RN - 0 (Antirheumatic Agents) SB - IM MH - Humans MH - Prospective Studies MH - Treatment Outcome MH - Pyrroles/adverse effects MH - Canada MH - *Arthritis, Rheumatoid/diagnosis/drug therapy/epidemiology MH - *Antirheumatic Agents/adverse effects PMC - PMC10091934 FIR - Pont, Karen IR - Pont K FIR - Teo, Michelle IR - Teo M FIR - Chan, John IR - Chan J FIR - Jamal, Shahin IR - Jamal S FIR - Baker, Milton IR - Baker M FIR - McCarthy, Timothy IR - McCarthy T FIR - Khraishi, Majed IR - Khraishi M FIR - Rahman, Al-Amin Proton IR - Rahman AP FIR - Sutton, Evelyn IR - Sutton E FIR - Lazovskis, Juris IR - Lazovskis J FIR - Pavlova, Viktoria IR - Pavlova V FIR - Haaland, Derek A IR - Haaland DA FIR - Papneja, Tripti IR - Papneja T FIR - Dixit, Sanjay IR - Dixit S FIR - Pandith, Vikas IR - Pandith V FIR - Boulos, Pauline IR - Boulos P FIR - Lau, Arthur IR - Lau A FIR - Mulgund, Manisha IR - Mulgund M FIR - Rai, Raman IR - Rai R FIR - Dekis, Alaa IR - Dekis A FIR - Ruban, Thanu IR - Ruban T FIR - Chow, Andrew IR - Chow A FIR - Florica, Brandusa IR - Florica B FIR - Khan, Imtiaz IR - Khan I FIR - Thorne, Carter IR - Thorne C FIR - Dhillon, Rajwinder IR - Dhillon R FIR - Lisnevskaia, Larissa IR - Lisnevskaia L FIR - Jovaisas, Algis IR - Jovaisas A FIR - Kapur, Suneil IR - Kapur S FIR - Montgomery, Angela IR - Montgomery A FIR - Shaikh, Saeed IR - Shaikh S FIR - Karasik, Arthur IR - Karasik A FIR - Keystone, Edward IR - Keystone E FIR - Pedvis, Stacey IR - Pedvis S FIR - Anwar, Sabeen IR - Anwar S FIR - Rodrigues, Jude IR - Rodrigues J FIR - Fallavollita, Sabrina IR - Fallavollita S FIR - Haraoui, Boulos IR - Haraoui B FIR - Shulz, Jan IR - Shulz J FIR - Tsoukas, Alexander IR - Tsoukas A FIR - Zummer, Michel IR - Zummer M FIR - Bessette, Louis IR - Bessette L FIR - Fortin, Paul R IR - Fortin PR FIR - Fortin, Isabelle IR - Fortin I FIR - Attie, Nabil IR - Attie N FIR - Boire, Gilles IR - Boire G FIR - Masetto, Ariel IR - Masetto A FIR - Lessard, Clode IR - Lessard C FIR - Anderson, Keltie IR - Anderson K FIR - Arendse, Regan IR - Arendse R FIR - Naik, Latha IR - Naik L EDAT- 2022/06/10 06:00 MHDA- 2023/02/14 06:00 PMCR- 2023/04/12 CRDT- 2022/06/09 11:02 PHST- 2022/04/18 00:00 [revised] PHST- 2021/12/22 00:00 [received] PHST- 2022/05/31 00:00 [accepted] PHST- 2022/06/10 06:00 [pubmed] PHST- 2023/02/14 06:00 [medline] PHST- 2022/06/09 11:02 [entrez] PHST- 2023/04/12 00:00 [pmc-release] AID - ACR24966 [pii] AID - 10.1002/acr.24966 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2023 Feb;75(2):240-251. doi: 10.1002/acr.24966. Epub 2022 Oct 10.