PMS2 Patient-Reported Outcomes in Rheumatoid Arthritis Patients Treated with Tofacitinib or Biological Dmards in Real Life Conditions: Colombian and Peru Perspective

Madariaga, H.; Reyes, Sanchez Jm; Gutierrez, Ardila M; Ponce, de Leon D; Lukić, Tamara; Amador, Laydamí Rodríguez

doi:10.1016/j.jval.2021.04.679

Cited by 2 publications

(3 citation statements)

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“…Improvements in pain and HAQ DI score following tofacitinib treatment were reported in CorEvitas ( 18 ) and an observational Latin American study ( 35 ), respectively, yet data on real‐world changes in clinically important patient‐reported outcomes are limited. Despite originating from a real‐world patient population, with 62.7% receiving concomitant csDMARDs, long disease duration, and varied comorbidity status, patients in CANTORAL experienced improvements in mild, moderate, and substantial pain, and FACIT‐F and HAQ DI normative thresholds aligned with values reported in a post hoc analysis of tofacitinib phase III studies ( 36 ).…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…A noninterventional study was conducted in Colombia and Peru to describe the baseline changes at 6 months in the outcomes associated to physical activity, disease activity, quality of life, and safety in patients with RA treated with tofacitinib or bDMARDs after the failure of conventional DMARDs in real‐life conditions register in Clinical trial. According to the analysis, access barriers and other related variables were significant associated to the baseline clinical outcomes changes observed for both treatments 20 …”

Section: Introductionmentioning

confidence: 98%

“…According to the analysis, access barriers and other related variables were significant associated to the baseline clinical outcomes changes observed for both treatments. 20 Although there are studies assessing PROs and the safety of RA treatment, particularly with bDMARDs, data related to current access to treatments, especially to tofacitinib, are scarce in Latin American countries. Additionally, there are no data on the association between PROs and the access barriers patients face; and thus, researchers are unable to capture the differences in treatment outcomes with tofacitinib or bDMARDs.…”

mentioning

confidence: 99%

Impact of access to treatment on patient‐reported outcomes among rheumatoid arthritis patients with tDMARDs and bDMARDS in two Latin‐American countries: A prospective observational study

Reyes¹,

Gutierrez-Ardila

Madariaga³

et al. 2023

Health Science Reports

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Background and Aims: A noninterventional prospective study was performed in Colombia and Peru. The aim was to describe the impact of access to treatment on Patient-reported outcomes (PRO) in patients with Rheumatoid arthritis (RA) after failure to conventional disease-modifying antirheumatic drugs (DMARDs) in real-life conditions. Methods:The impact of access to treatment was measured by access barriers, time to supply (TtS) and interruption evaluating their effect in changes of PROs between baseline and 6-month follow-up between February 2017 and November 2019. The association of access to care with disease activity, functional status, health-related quality of life was assessed using bivariate and multivariable analysis. Results are expressed in least mean difference; TtS in mean number of days for delivery of treatment at baseline. Variability measures were standard deviation and standard error.Results: One hundred seventy patients were recruited, 70 treated with tofacitinib and 100 with biological DMARDs. Thirty-nine patients reported access barriers. The mean of TtS was 23 ± 38.83 days. The difference from baseline to 6-month visit in PROs were affected by access barriers and interruptions. There was not statistically significant difference in the of PRO's score among visits in patients that reported delay of supply of more than 23 days compared to patients with less days of delay. Conclusion:This study suggested the access to treatment can affect the response to the treatment at 6 months of follow-up. There seems to be no effect in the PROs for delay of TtS during the studied period.

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PMS2 Patient-Reported Outcomes in Rheumatoid Arthritis Patients Treated with Tofacitinib or Biological Dmards in Real Life Conditions: Colombian and Peru Perspective

Cited by 2 publications

References 0 publications

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

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

Impact of access to treatment on patient‐reported outcomes among rheumatoid arthritis patients with tDMARDs and bDMARDS in two Latin‐American countries: A prospective observational study

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