ObjectiveTo describe the rate of concomitant oral corticosteroid use at antitumour necrosis factor (TNF) initiation and at disease remission, and to assess its effect on incidence of infection and sustainability of remission among patients with rheumatoid arthritis (RA) treated with infliximab in Canadian routine care.MethodsBiological naïve patients with RA followed in the Biologic Treatment Registry Across Canada (BioTRAC) were included. The time-dependent association between corticosteroid dose (no use, ≤5 mg/day, >5 mg/day) and the incidence of first infection, while considering possible confounders, remission sustainability and the incidence of subsequent infections were assessed with Cox regression.Results838 patients were included; mean (SD) baseline age and disease duration were 55.6 (13.5) and 10.5 (9.8) years, respectively. After a mean (SD) of 51.3 (43.6) months, the total incidence of adverse events (AEs) and infections were 110.2 and 19.6 per 100 person-years (PY), respectively. In multivariate analysis, the HR (95% CI) for acquiring an infection was 2.48 (1.24 to 4.98) with >5 mg/day of corticosteroids versus no corticosteroids. Similarly, ≤5 mg/day of corticosteroids was associated with increased hazard for infection (2.12 (0.97 to 4.66)). Despite DAS28 (disease activity score 28) or Clinical Disease Activity Index (CDAI) remission, corticosteroids were continued in 16.4% and 16.7% of cases, respectively. Continued corticosteroid treatment was not associated with sustainability of remission (HRDAS28 (95% CI) 1.40 (0.95 to 2.06); HRCDAI 1.19 (0.75 to 1.88)), however, it had a significant impact on development of infection (HRDAS28 (95% CI) 1.78 (1.00 to 3.19); HRCDAI 2.38 (1.14 to 4.99)).ConclusionsOral corticosteroid treatment was associated with increased risk of development of infection without impacting sustainability of remission. These results support the notion that corticosteroids should be used concomitantly with anti-TNF for the shortest period possible to achieve remission, and then tapered.Trial registration numberNCT00741793.
ObjectiveTo identify factors associated with work-related issues in Canadian patients with axial spondyloarthritis (axSpA).MethodsData from 542 Canadian patients who participated in the International Map of Axial Spondyloarthritis (IMAS) online survey were analysed. Participants who were employed, unemployed, or on short-term disability were included in this analysis. Regression analysis was used to study the association between work-related issues, disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), and psychological distress (12-item General Health Questionnaire [GHQ-12]).ResultsMean ± SD age of surveyed participants was 44.3 ± 13.9 years, 81.0% were university educated, and 52.6% employed. A substantial proportion had high disease activity (BASDAI, 72.1%) and psychological distress (GHQ-12, 53.1%); 81.1% had workrelated issues. This study analysed responses from a subset of participants who were either employed, unemployed, or on short-term disability (n=339). Ninety percent of this subset reported at least one work-related issue in the year before questionnaire completion, with the most frequent being absenteeism (49.3%) and missing work for healthcare provider visits (42.5%). Factoring in disability benefits eliminated the association between work-related issues and disease activity, for all variables except fatigue (r=0.217; p=0.028) and discomfort (r=0.196; p=0.047). Difficulty fulfilling working hours (B=2.342; 95% CI, 1.413 to 3.272) and impact on professional advancement (B=1.426; 95% CI, 0.355 to 2.497) were associated with psychological distress. In the presence of disability benefits, only the impact on professional advancement remained (B=2.304; 95% CI, 0.082 to 4.527).ConclusionWork-related issues are associated with worse patient-reported outcomes, both physical and psychological.
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.
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