AB0419 Real world use of tofacitinib in rheumatoid arthritis: data from latin america

Schneeberger, E. E.; Salas, A; Medina, LF; Zacariaz, JB; Mantilla, RD; Sarmiento-Monroy, JC; Elizondo, LJ; Garro, Boris; Madariaga, H.; Gorriz, L.; Giorgi, R.; Pinheiro, Marcelo Maia; León, Darío Ponce de

doi:10.1136/annrheumdis-2017-eular.1607

Cited by 8 publications

(10 citation statements)

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“…In this study, we reported the real-life efficacy, drug retention and safety of tofacitinib in [22]. These data are in line with our study and the efficacy of tofacitinib also demonstrated in small observational studies [23][24][25].…”

Section: Discussionsupporting

confidence: 89%

Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience

Bılgın¹,

Ceylan²,

Duran³

et al. 2021

Turk J Med Sci

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Objective: To assess the real-life efficacy, retention rate and safety data of tofacitinib in rheumatoid arthritis (RA) patients. Method: We analyzed all patients registered in the HURBİO database who received at least 1 dose of tofacitinib. Patients who received at least one dose included in retention analysis, with at least 1 control visit, were included in efficacy and safety analysis. Factors predicting good response at last follow-up visit were analyzed by the logistic regression analysis. Drug retention rates were calculated using the Kaplan-Meier method and predictors of drug retention was determined by Cox proportional hazard model. Adverse events, reasons of switching and discontinuation were also determined. Results: 247 (210, 85.0% female) patients included in the study. Median duration of tofacitinib treatment was 10.2 (20.2) (med, (IQR)) months. 204 (82.6%) patients included in safety and efficacy analysis. 45.6% of patients was in low-disease activity (LDA) state (DAS28-CRP≤3.2). Predictors of LDA were being biologic-navie (aOR 2.53 (1.31-4.88); 95% CI) and RF negativity (aOR 2.14 (1.12-4.07); 95% CI). At 1 year, overall tofacitinib retention rate was 63.9% with no relevant predicting factor. Response and retention rates of tofacitinib were similar in patients with and without concomitant csDMARDs. Treatment failure was the most common cause of discontinuation. The most common infectious and laboratory adverse events were herpes zoster infection (3.9 per 100 patient-years) and elevation in ALT (x3UNL: 9.7 per 100 patient-years), respectively. Conclusion: In conclusion, tofacitinib is an effective-as monotherapy or combination with csDMARDs-and well-tolerated treatment option in Turkish RA patients.

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Section: Discussionsupporting

confidence: 89%

Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience

Bılgın¹,

Ceylan²,

Duran³

et al. 2021

Turk J Med Sci

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“…In the absence of information on the causes of discontinuing the medications, we could not provide further explanation for this observation. Previous cohort studies reported discontinuation due to adverse events in 3.2-24.3% of the patients who were followed for 6-22 months (37,(40)(41)(42)(43)(44)(45). In those studies, 1.6-20.8% of tofacitinib users discontinued their treatment due to a lack/loss of efficacy.…”

Section: Discussionmentioning

confidence: 99%

Tofacitinib Persistence in Patients with Rheumatoid Arthritis: A Retrospective Cohort Study

Fisher¹,

Hudson²,

Platt

et al. 2020

J Rheumatol

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Objective To compare medication persistence of tofacitinib with persistence of injectable biological disease-modifying antirheumatic drugs (bDMARD) in patients with rheumatoid arthritis (RA). Methods We performed a retrospective new-user cohort study of patients with RA in the IBM MarketScan Research Databases. New users of tofacitinib or bDMARD were identified between November 2012 and December 2016. Persistence, in number of years, was the time between treatment initiation and the earliest occurrence of discontinuation or switching from the medication prescribed at cohort entry. Persistence of tofacitinib was compared with bDMARD persistence using Cox proportional hazards regression with adjustment for high-dimensional propensity scores. Similar methods were used for an analysis of post first‑line therapy in patients who switched to tofacitinib from a bDMARD. Results New tofacitinib users (n = 1031) were 56 years of age, on average, and 82% were women. New bDMARD users (n = 17,803) were 53 years of age, on average, and 78% were women. New tofacitinib users had shorter medication persistence (median 0.81 yrs) compared to bDMARD patients (1.02 yrs). After adjustment, the HR for discontinuation of tofacitinib compared with bDMARD was 1.14 (95% CI 1.05–1.25). Patients who switched to tofacitinib from a bDMARD had longer persistence than patients who switched to a bDMARD (adjusted HR for discontinuation 0.90, 95% CI 0.83–0.97). Conclusion Further research is warranted to understand the reasons for discontinuation of tofacitinib despite its ease of administration and to understand the observed differences between switchers and new users.

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“…Real-world assessment is necessary to inform clinicians of appropriate treatment targets and to provide insights into safety outcomes in populations ineligible for clinical trials. Such benefit/ risk profile assessments of tofacitinib, and other JAK inhibitors in patients with RA have been described globally (10)(11)(12)(13)(14)(15)(16)(17)(18)(19). Demographic information and persistence of tofacitinib in Canadian patients with RA have been reported in an analysis of data from a patient-support program; however, clinical effectiveness or safety was not assessed (20).…”

Section: Introductionmentioning

confidence: 99%

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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AB0419 Real world use of tofacitinib in rheumatoid arthritis: data from latin america

Cited by 8 publications

References 0 publications

Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience

Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience

Tofacitinib Persistence in Patients with Rheumatoid Arthritis: A Retrospective Cohort Study

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

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