The incidence of renal biopsy-proven AAV was higher in patients living in northern Saskatchewan smaller communities and rural settings. A significantly longer time to diagnosis existed for patients outside the urban centre and was associated with poorer BVAS, VDI and FFS scores.
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 (≤0.25) and a HAQ DI score greater or equal to minimum clinically important difference (MCID) (≥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-ESRdefined 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 patientyears) 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 realworld patients. Effectiveness and safety were consistent with the established tofacitinib clinical profile.
BackgroundLong-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time.ObjectivesTo describe the profile of rheumatoid arthritis (RA) patients treated with infliximab (IFX), golimumab subcutaneous (GLM) or intravenous (GLM-IV) in Canadian routine care, along with its effectiveness and safety.Methods1577 RA patients treated with IFX, GLM or GLM-IV were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28, SJC28, MDGA, PtGA, pain, HAQ, and acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival.ResultsOf the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females were 75.7%- 77.1%, the mean age were 55.8-57.7 and the mean disease duration were 6.5-8.6 years. Most patients were bio-naive (> 80%).A significant decrease in disease duration and disease activity scores (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) were observed in the IFX cohort over time (p<0.001). Interestingly, baseline disease duration and disease activity scores for the GLM cohort (DAS, TJC, SJC, PtGA, Pain, CRP, ESR) were higher than in the IFX cohort from 2010-2012 when GLM was first introduced while the mean MDGA remained the same between the two groups.Treatment with IFX, GLM and GLM-IV significantly improved all disease parameters over time (P<0.001) from baseline to 6 months and up to 120, 78 and 42 months, respectively. The proportion of patients in SDAI remission at 12, 24 and 36 months reached 16.2%, 20.8% and 22.8% in IFX-patients; 34.7%, 47.5% and 52.7% in GLM-patients and 33.8%, 47.5% and 61.9% in GLM-IV-patients (p=0.1978 and p=0.0081 vs IFX).AEs were reported for 61.5%, 67.4% and 59.2% (105, 113 and 82.6 events/100 PYs) and SAEs for 21.2%, 15.5% and 3.8% (11.7, 34.4 and 9.0 events/100 PYs) covering 2714, 1077 and 257 years of exposure for IFX, GLM and GLM-IV-treated patients, respectively. The most frequently occurring AEs were arthralgia and upper respiratory tract infection (>5%). Eighteen, 7 and 1 deaths occurred among IFX-, GLM- and GLM-IV-treated patients, respectively. The proportion of patients who discontinued treatment were 74.0% over a mean 3.0 years of exposure to IFX-, 52.8% over 2.0 years of exposure to GLM and 45.2% over 1.6 year of exposure to GLM-IV.ConclusionIn this real-world study of Canadian patients with RA, differences in baseline characteristics between patients treated with an anti-TNF over time and between agents shows potential selection biases when selecting a given therapy and may impact the proportion of patients achieving a target-specific outcome. Treatment significantly reduced disease activity and improved functionality in a similar fashion and were also safe and well tolerated. Disclosure of Interests: Proton Rahman: None declared, Philip Baer Grant/r...
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