Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

Rahman, Proton; Baer, P.; Keystone, Ed; Choquette, D.; Thorne, Carter; Chow, Andrew; Faraawi, R.; Olszynski, Wojciech P.; Kelsall, J.; Rampakakis, Emmanouil; Lehman, A.J.; Nantel, F.

doi:10.1186/s41927-020-00145-4

Cited by 9 publications

(17 citation statements)

References 31 publications

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“…Twenty-one records were eligible for inclusion in this systematic review; seven population-based cohorts ( Østergaard et al, 2007 ; Chatzidionysiou et al, 2015 ; Neovius et al, 2015 ; Acurcio et al, 2016 ; Kihara et al, 2017 ; Choi et al, 2021 ; Li et al, 2021 ), eight prospective ( Harrold et al, 2015 ; Lauper et al, 2018 ; Ebina et al, 2020a , 2020b ; Rahman et al, 2020 ; Curtis et al, 2021 ; Pappas et al, 2021a , 2021b ), and six retrospective cohort studies ( Curtis et al, 2015 ; Yun et al, 2015 ; Silvagni et al, 2018 ; Bird et al, 2020 ; Gharaibeh et al, 2020 ; Youssef et al, 2020 ), which are published from 2007 to 2021 ( Supplementary Table S2 ).…”

Section: Resultsmentioning

confidence: 99%

“…Ten studies compromised RA patients in second-line therapy ( Chatzidionysiou et al, 2015 ; Harrold et al, 2015 ; Kihara et al, 2017 ; Lauper et al, 2018 ; Ebina et al, 2020a , 2020b ; Rahman et al, 2020 ; Youssef et al, 2020 ; Choi et al, 2021 ; Curtis et al, 2021 ), nine in first-line therapy ( Østergaard et al, 2007 ; Neovius et al, 2015 ; Yun et al, 2015 ; Silvagni et al, 2018 ; Bird et al, 2020 ; Gharaibeh et al, 2020 ; Li et al, 2021 ; Pappas et al, 2021b , 2021a ), and two did not report this information ( Curtis et al, 2015 ; Acurcio et al, 2016 ) ( Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…One research included patients with previous therapy with bDMARDs and concurrent DMARDs ( Curtis et al, 2021 ). Another study indicated a proportion of biologic-experienced RA patients of 6.3–19.7% ( Rahman et al, 2020 ).…”

Section: Resultsmentioning

confidence: 99%

“…Furthermore, fourteen records described the proportion of RA patients in current use of steroids ( Chatzidionysiou et al, 2015 ; Curtis et al, 2015 ; Yun et al, 2015 ; Harrold et al, 2015 ; Kihara et al, 2017 ; Silvagni et al, 2018 ; Lauper et al, 2018 ; Ebina et al, 2020a , 2020b ; Rahman et al, 2020 ; Youssef et al, 2020 ; Gharaibeh et al, 2020 ; Pappas et al, 2021a , 2021b ), which ranged from 9.9 to 78.0%; however, none of these studies did a separate analysis for patients who are currently exposed to steroids and unexposed to steroids.…”

Section: Resultsmentioning

confidence: 99%

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Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: Systematic review and meta-analysis

Castro

Queiroz²,

Albuquerque³

et al. 2022

Front. Pharmacol.

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Background: The treatment of rheumatoid arthritis (RA), a chronic systemic inflammatory autoimmune disease, is based on disease-modifying anti-rheumatic drugs (DMARDs). Typically, it starts with conventional synthetic DMARDs (csDMARDs), and depending on the patient’s response to the treatment and the adverse events experienced, biological DMARDs (bDMARDs) are initiated. bDMARDs are more specific to inflammatory factors than csDMARDs and more efficient in inducing remission and low disease activity. Thus, this study aimed to assess the effectiveness of biological therapy in patients with rheumatoid arthritis in administrative health databases.Methods: PubMed, Embase, Lilacs, Ovid, Scopus, and Web of Science databases were searched from inception to 21 October 2021, to identify observational studies that evaluated the effectiveness of biological therapy in patients with rheumatoid arthritis using administrative databases and real-world data. The methodological quality was assessed by the methodological index for non-randomized studies (MINORS). A fixed or random-effects model estimated risk ratios with 95% confidence intervals. The analysis was divided into four groups: tumor necrosis factor inhibitors (TNFi) versus non-TNFi; TNFi versus TNFi (adalimumab, etanercept, and golimumab versus infliximab); bDMARDs versus Janus kinase inhibitors (JAKi); and bDMARDs monotherapy versus combination therapy (bDMARDs and MTX).Results: Twenty-one records were eligible for inclusion in this systematic review and meta-analysis; seven population-based cohorts, eight prospective, and six retrospective cohort studies. Overall, 182,098 rheumatoid arthritis patients were evaluated. In the meta-analysis, lower effectiveness was observed among TNFi users than in non-TNFi (RR: 0.88; 95% CI: 0.81–0.95; p < 0.01; I2 = 94.0%) and bDMARDs than in JAKi (RR: 0.86; 95% CI: 0.79–0.94; p < 0.01; I2 = 93.0%). Higher effectiveness among adalimumab, etanercept, and golimumab than in infliximab (RR: 1.19; 95% CI: 1.05–1.36; p < 0.01; I2 = 96.0%) was found. No significant differences in the effectiveness of bDMARD monotherapy compared to combination therapy (RR: 0.83; 95% CI: 0.68–1.00; p < 0.01; I2 = 81.0%) was observed. E-value analysis indicated that the estimates were not robust against unmeasured confounding.Conclusion: According to the available real-world data, our results suggest that biological therapy effectively treats patients with rheumatoid arthritis, indicating higher effectiveness with non-TNFi and JAKi than with TNFi.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID#CRD42020190838, identifier CRD42020190838.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: Systematic review and meta-analysis

Castro

Queiroz²,

Albuquerque³

et al. 2022

Front. Pharmacol.

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“…In comparison to other TNFi, GOL shows similar efficacy and safety [66,67], but seems to be less effective than other TNFis in patients with multiple biological treatment failures [68]. In comparative trials, there were no significant divergences in effectiveness or safety between GOL and other TNFis [69]. GOL also might be considered as a safe drug during lactation, because its high mass might prevent its exudation to breast milk [70].…”

Section: Golimumab (Gol)-fully Human Monoclonal Antibodymentioning

confidence: 99%

Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment

Bonek

Roszkowski

Massalska

et al. 2021

Cells

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Rheumatoid arthritis (RA) affects around 1.2% of the adult population. RA is one of the main reasons for work disability and premature retirement, thus substantially increasing social and economic burden. Biological disease-modifying antirheumatic drugs (bDMARDs) were shown to be an effective therapy especially in those rheumatoid arthritis (RA) patients, who did not adequately respond to conventional synthetic DMARD therapy. However, despite the proven efficacy, the high cost of the therapy resulted in limitation of the widespread use and unequal access to the care. The introduction of biosimilars, which are much cheaper relative to original drugs, may facilitate the achievement of the therapy by a much broader spectrum of patients. In this review we present the properties of original biologic agents based on cytokine-targeted (blockers of TNF, IL-6, IL-1, GM-CSF) and cell-targeted therapies (aimed to inhibit T cells and B cells properties) as well as biosimilars used in rheumatology. We also analyze the latest update of bDMARDs’ possible influence on DNA methylation, miRNA expression and histone modification in RA patients, what might be the important factors toward precise and personalized RA treatment. In addition, during the COVID-19 outbreak, we discuss the usage of biologicals in context of effective and safe COVID-19 treatment. Therefore, early diagnosing along with therapeutic intervention based on personalized drugs targeting disease-specific genes is still needed to relieve symptoms and to improve the quality of life of RA patients.

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Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study

Khraishi

Choquette²,

Lisnevskaia

et al. 2022

Arthritis Care & Research

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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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Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

Cited by 9 publications

References 31 publications

Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: Systematic review and meta-analysis

Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: Systematic review and meta-analysis

Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment

Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study

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