Dataset Information

Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab.

ABSTRACT:

Background

As significant advances in the field of treatment for rheumatoid arthritis (RA), there is a great need to identify the healthcare outcomes such as treatment satisfaction and health-related quality of life (HRQoL) of patients with various treatment options. This study aims to identify the difference in the treatment satisfaction and HRQoL of patients with RA using different treatment options, by comparing the treatment satisfaction and HRQoL in patients with RA treated with tofacitinib and adalimumab in real-world settings in Korea, using propensity score methods.

Methods

In this non-interventional, multicenter, cross-sectional study (NCT03703817), a total of 410 patients with RA diagnosis were recruited in 21 university-based hospitals throughout Korea. The treatment satisfaction and HRQoL were assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) and EQ-5D questionnaires self-reported by the patients. This study compared outcomes between two drug groups in unweighted, greedy matching, and stabilized inverse probability of treatment weight (IPTW) samples using propensity score.

Results

In all three samples, tofacitinib group showed higher convenience domain of TSQM than that in the adalimumab group, but not effectiveness, side effects, and global satisfaction domains. Multivariable analysis using the covariates of demographic and clinical characteristics of the participants also showed consistent results in TSQM. No statistical difference in EQ-5D-based HRQoL was identified between two drug groups in all three samples.

Conclusions

This study identified that tofacitinib shows higher treatment satisfaction in the convenience domain of TSQM rather than adalimumab, suggesting that various factors such as drug formulation, route or frequency of administration, and storage can have an impact on the treatment satisfaction, especially the convenience domain. These findings may be useful to patients and physicians when determining treatment options.

Trial registration

ClinicalTrials.gov, NCT03703817.

SUBMITTER: Kim SK

PROVIDER: S-EPMC10134656 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab.

Kim Seong-Kyu SK Lee Sang-Heon SH Sun Jiyu J Lee Soo Hyun SH Jeon Ja-Young JY Yoo Hyun-Jeong HJ Choe Jung-Yoon JY

Arthritis research & therapy 20230427 1

<h4>Background</h4>As significant advances in the field of treatment for rheumatoid arthritis (RA), there is a great need to identify the healthcare outcomes such as treatment satisfaction and health-related quality of life (HRQoL) of patients with various treatment options. This study aims to identify the difference in the treatment satisfaction and HRQoL of patients with RA using different treatment options, by comparing the treatment satisfaction and HRQoL in patients with RA treated with tof ...[more]

PMID: 37106411

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Project description:IntroductionTo compare the economic benefit of upadacitinib combination therapy versus tofacitinib combination therapy and upadacitinib monotherapy versus methotrexate monotherapy from improvements in health-related quality of life (HRQOL) in patients with rheumatoid arthritis (RA).MethodsData were analyzed from two trials of upadacitinib (SELECT-NEXT and SELECT-MONOTHERAPY) and one trial of tofacitinib (ORAL-Standard) that collected HRQOL measurements using the Short Form 36 (SF-36) Health Survey in patients with RA. Direct medical costs per patient per month (PPPM) for patients receiving upadacitinib 15 mg once daily and methotrexate were derived from observed SF-36 Physical (PCS) and Mental Component Summary (MCS) scores in the SELECT trials using a regression algorithm. Direct medical costs PPPM for patients receiving tofacitinib 5 mg twice daily were obtained from a published analysis of SF-36 PCS and MCS scores observed in the ORAL-Standard trial. Short-term (12-14 weeks) and long-term (48 weeks) estimates of direct medical costs PPPM were compared between upadacitinib and tofacitinib and between upadacitinib and methotrexate.ResultsOver 12 weeks, direct medical costs PPPM were $252 lower (95% CI $72, $446) for upadacitinib-treated patients versus tofacitinib-treated patients. Medical costs PPPM at weeks 24 and 48 and cumulative costs over the entire 48-week period (difference $1759; 95% CI $1162, $2449) were significantly lower for upadacitinib than for tofacitinib. Over 14 weeks, direct medical costs PPPM were $399 lower (95% CI $158, $620) for patients treated with upadacitinib monotherapy compared with those treated with methotrexate alone. Direct medical costs at week 48 and cumulative costs over the entire 48-week period (difference $2044; 95% CI $1221, $2846) were significantly lower for upadacitinib monotherapy compared with methotrexate alone.ConclusionIn the short and long term, upadacitinib combination therapy versus tofacitinib combination therapy and upadacitinib monotherapy versus methotrexate monotherapy were associated with significantly lower direct medical costs for patients with RA.Trial registrationClinicalTrials.gov identifier, NCT02675426, NCT02706951, and NCT00853385.

Project description:ImportanceThere is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) and tofacitinib (TOF) were shown to be equivalent in patients with rheumatoid arthritis (RA) in a randomized clinical trial, but to our knowledge, these drugs have not been compared head-to-head using routinely collected clinical data and the TTE framework.ObjectiveTo emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).Design, setting, and participantsThis comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in Australian Rheumatology (OPAL) data set. Patients were included if they initiated ADA or TOF between October 1, 2015, and April 1, 2021; were new b/tsDMARD users; and had at least 1 component of the disease activity score in 28 joints using C-reactive protein (DAS28-CRP) recorded at baseline or during follow-up.InterventionTreatment with either ADA (40 mg every 14 days) or TOF (10 mg daily).Main outcomes and measuresThe main outcome was the estimated average treatment effect, defined as the difference in mean DAS28-CRP among patients receiving TOF compared with those receiving ADA at 3 and 9 months after initiating treatment. Missing DAS28-CRP data were multiply imputed. Stable balancing weights were used to account for nonrandomized treatment assignment.ResultsA total of 842 patients were identified, including 569 treated with ADA (387 [68.0%] female; median age, 56 years [IQR, 47-66 years]) and 273 treated with TOF (201 [73.6%] female; median age, 59 years [IQR, 51-68 years]). After applying stable balancing weights, mean DAS28-CRP in the ADA group was 5.3 (95% CI, 5.2-5.4) at baseline, 2.6 (95% CI, 2.5-2.7) at 3 months, and 2.3 (95% CI, 2.2-2.4) at 9 months; in the TOF group, it was 5.3 (95% CI, 5.2-5.4) at baseline, 2.4 (95% CI, 2.2-2.5) at 3 months, and 2.3 (95% CI, 2.1-2.4) at 9 months. The estimated average treatment effect was -0.2 (95% CI, -0.4 to -0.03; P = .02) at 3 months and -0.03 (95% CI, -0.2 to 0.1; P = .60) at 9 months.Conclusions and relevanceIn this study, there was a modest but statistically significant reduction in DAS28-CRP at 3 months for patients receiving TOF compared with those receiving ADA and no difference between treatment groups at 9 months. Three months of treatment with either drug led to clinically relevant average reductions in mean DAS28-CRP, consistent with remission.

Project description:BackgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA.MethodsAnalyses included patients treated with adalimumab 40 mg once every 2 weeks or tofacitinib 10 mg twice daily (BID) with background methotrexate (MTX) in a 12-month randomized study (NCT00853385), who subsequently received tofacitinib 10 mg BID (with/without background MTX) in an open-label extension (NCT00413699). Patients with treatment-related serious adverse events (AEs) and serious or recurrent infections in the index study were excluded from the extension study. Exposure-adjusted incidence rates of safety-related events were assessed in 3-month and 12-month periods in the year before and in the year after switching. Efficacy was assessed 3 months before, at the time of, and 3 months after switching.ResultsThere were 233 (107 adalimumab to tofacitinib 10 mg BID, 126 blinded to open-label tofacitinib 10 mg BID) patients included in these analyses. Patients in both treatment sequences had similar incidence rates (per 100 patient-years) of discontinuation due to AEs, serious AEs, and serious infections in the year before and in the year after switching. Incidence rates of AEs were increased in the first 3 months after switching compared with the last 3 months before switching in both treatment groups. Switching from either blinded adalimumab or tofacitinib to open-label tofacitinib resulted in numerically higher incidence of responders for signs and symptoms of disease and improved physical function.ConclusionsTreatment can be directly switched from adalimumab to tofacitinib. A similar safety and efficacy profile was seen when patients received open-label tofacitinib after receiving either blinded adalimumab or tofacitinib.Trial registrationClinicalTrials.gov Identifiers: NCT00853385 , registered 27 February 2009; NCT00413699 , registered 18 December 2006.

Project description:BackgroundStudying health-related quality of life (HRQoL) and treatment satisfaction have helped in understanding how to optimize rheumatoid arthritis (RA) treatment outcomes and find ways to alleviate signs and symptoms among patients.ObjectiveIn this study, our objective was to evaluate the association between satisfaction with care and HRQoL among RA patients from northern Palestine. In addition, this study also aimed to determine the associations between the clinical characteristics of patients with RA with treatment satisfaction and HRQoL.MethodsThis was a multicenter cross-sectional study conducted between July and October 2018. Patients with RA diagnosis who presented at rheumatology clinics were interviewed. The SF-36 short questionnaire was used to assess HRQoL and Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 to assess treatment satisfaction among study groups. We use descriptive and comparative statistics to present the results.ResultsA total of 283 patients were included. Several sociodemographic and clinical characteristics were found to be associated with poor HRQoL scores and low treatment satisfaction. The physical component summary (PCS) was negatively associated with age, patients' self-reported disease activity, duration of the disease, and the total number of medications taken by the patient, and was positively associated with educational background, employment, and household income. The mental component summary (MCS) was negatively associated with patients' self-reported disease activity and the patient's total number of comorbid diseases. The number of comorbid diseases was negatively associated with effectiveness. All HRQoL subscales were significantly correlated with treatment satisfaction. The range of correlation with PCS was between 0.272 for convenience and 0.425 for side effects (p < 0.001). Similarly, the highest correlation with MCS was 0.458 for side effects, and the lowest was 0.337 for convenience (p < 0.001).ConclusionsThe current study found that HRQoL was significantly correlated with treatment satisfaction. Furthermore, the results of this study showed that HRQoL and treatment satisfaction are likely to be affected by sociodemographic and clinical characteristics. These results may be beneficial in clinical practice, mainly in the early treatment of patients with RA, at a stage where it is still possible to increase treatment satisfaction.

Project description:BackgroundRheumatoid arthritis (RA) is a chronic systemic autoimmune disease that primarily affects joints with some extraarticular involvement. If inappropriately treated, it usually results in persistent joint pain, irreversible deformities, and functional disability, leading to poor quality of life. Our objective was to evaluate health-related quality of life (HRQoL) and related factors in patients with RA.MethodsFour hundred sixty-four patients from the Rheumatoid Arthritis registries of Siriraj and Phramongkutklao teaching hospitals were enrolled. Sociodemographic, clinical and laboratory data related to disease activity, and functional status were collected. HRQoL was assessed using the Thai version of EuroQol five dimensional questionnaire (EQ-5D) and EQ global health visual analogue scale (EQ VAS). Univariate and multivariate analyses were employed to identify factors related to HRQoL.ResultsEighty-five percent were female with a mean age ± SD of 59.15 ± 11.43 years and a mean disease duration ± SD of 11.53 ± 8.3 years. The mean educational level ± SD was 9.42 ± 5.21 years. Almost half were unemployed or retired (47%). They had moderate disease activity (mean cumulative DAS28 ± SD, 3.5 ± 0.8) and mild functional impairment (mean HAQ ± SD, 0.70 ± 0.68). The mean EQ-5D ± SD (0-1) was 0.87 ± 0.13 and mean EQ VAS ± SD (0-10) was 7.94 ± 1.7. Based on the EQ-5D domain, 49% reported that they had no problem with mobility, 83% had no difficulties with self-care, 65% had no difficulties with usual activity, 30% had no pain or discomfort, and 61% had no depression or anxiety. The relationship between problems of each dimension in EQ-5D significantly increased according to severity of RA assessed by the Disease Activity Score (DAS) 28 and Health Assessment Questionnaire (HAQ) (p < 0.01). In multivariate analyses, high cumulative disease activity, functional disability, depression, and anxiety were negatively associated with EQ-5D (adjusted R 2 0.38, p < 0.001) and EQ VAS (adjusted R 2 0.19, p < 0.001).ConclusionDisease severity and psychological disturbance have a negative impact on quality of life in patients with RA. These factors should be considered in management of RA patients to improve the standard of care.

Project description:Although the rapid onset of effect of glucocorticoids (GCs) allows rapid control of rheumatoid arthritis (RA) symptoms, their chronic use may be associated with several adverse events. The 2022 update of EUALR recommendations for the management of patients with RA suggests to reduce and discontinue oral GCs as quickly as possible. Considering GCs as a "bridging therapy" to promptly reduce symptoms and control inflammation, fast-acting drugs such as tofacitinib could allow faster and safer tapering of GCs. The purpose of this pilot study was to evaluate the steroid-sparing effect of adding tofacitinib in patients with RA inadequately responsive to methotrexate taking concomitant GCs. In this open-label pilot study, we enrolled patients with moderate to severe RA on a stable dose of prednisone (5-12.5 mg/day) who started treatment with tofacitinib. After 1 month, in patients who achieved at least a moderate EULAR response (decrease of > 1.2 in DAS28_CRP), GCs was tapered according to a predetermined schedule until complete discontinuation at week 12. Disease activity was assessed after 4, 12, 24 and 48 weeks of treatment. The primary endpoint was the percentage of patients discontinuing GCs after 12 weeks of tofacitinib treatment. We enrolled 30 patients (26 F: 4 M, mean age 60 ± 13 years, mean disease duration 13.2 ± 7.8 years). The primary endpoint was achieved: 9 patients (30%) discontinued GCs at week-12. At week-24, other 12 patients (46%) withdrew GCs. The median prednisone dose decreased from 5 mg/day (interquartile range 5-10 mg) to 2.5 (0-5) mg/day at week 12 and 48 (p < 0.00001 vs baseline). At week 48, 12 out of 30 patients (40%) had discontinued prednisone. The percentage of patients achieving remission or low disease activity increased throughout the follow-up without any difference between patients who discontinued or not the GC. In this cohort of long-standing RA patients treated with tofacitinib, the discontinuation of glucocorticoids was achievable in up to 30% of patients. These results should encourage rheumatologists to consider GCs tapering and discontinuation of GCs, as suggested by the 2022 EULAR recommendations, an achievable goal.

Project description:BackgroundCompared to the healthy population, the psychological impact of rheumatoid arthritis(RA) on patients' lives could dramatically lower their oral health-related quality of life (OHRQoL). Our goal is to analyze OHRQoL in RA patients and look into the role of disease activity, dental health index, and Temporomandibular disorders score in maintaining their oral health.MethodsIn a cross-sectional comparative study, we compared a sample of 40 RA patients with 40 age- and gender-matched healthy controls in terms of oral health and OHRQoL. Temporomandibular disorders (TMD), number of decayed, filled, or missing teeth (DMFT), and Oral Health Impact Profile (OHIP) were among the oral health factors studied (OHIP-14). This study also looked at the link between the RA disease activity score (DAS28) and oral health factors.ResultsRA patients had a significantly higher mean (poorer OHRQol) than healthy controls in total oral function, total psychosocial impact, OHIP-14 sum score, OHIP-14 extent score, TMD score and the number of missed teeth (Mann-Whitney U test, P-value < 0.05). After adjustment for DMFT, only the oral function score of OHIP-14 had a significant correlation with disease activity (Mann-Whitney U test, P-value < 0.05). The TMD sum score significantly correlated with disease activity regardless of adjustment for DMFT (Spearman's Correlation test, P-value < 0.05 for both). The number of decayed teeth and missed teeth showed a positive correlation with increased disease activity (Coefficient = 0.239 and 0.245, P-value < 0.05 for both).ConclusionsPatients with RA are less satisfied with their oral health than healthy controls. In RA patients, the number of missing teeth and temporomandibular disorders was substantially greater, and the number of missing teeth and temporomandibular diseases increased significantly with increased disease activity. Although OHRQoL was inversely connected with RA activity, after correcting for decaying, missing, and filled teeth, only the oral function score of OHIP-14 exhibited a slight connection to DAS28.

Project description:BackgroundIncreased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA.MethodsBaseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6-7.1 pg/mL), medium (7.2-39.5 pg/mL), and high (39.6-692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID).ResultsAt baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar.ConclusionsPatients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade.Trial registrationNCT02332590 . Registered on 5 January 2015.

Dataset Information

Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab.

Background

Methods

Results

Conclusions

Trial registration

Publications

Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab.

Similar Datasets

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