Dataset Information

Fatigue Is Not Associated With Objective Assessments of Inflammation During Tocilizumab Treatment of Patients With Rheumatoid Arthritis.

ABSTRACT:

Objective

In patients with rheumatoid arthritis (RA), the relation between fatigue and disease activity is not established, and our objective was to explore in post hoc analyses the associations between fatigue and subjective as well as objective assessments of inflammation during follow-up of patients with RA initiating biologic treatment.

Methods

In a Nordic multicenter study, patients with RA starting tocilizumab were examined for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue sum score) as well as patient-reported outcome measures (PROMs) (patient's global disease activity, joint pain, and Health Assessment Questionnaire Disability Index), clinical examinations (examiner's global disease activity, 28 tender/swollen joint counts), laboratory variables (erythrocyte sedimentation rate, C-reactive protein), and ultrasound assessments (semiquantitative scoring [0-3]) of gray scale and Doppler of 36 joints and 4 tendons) at baseline and 4, 12, and 24 weeks. The associations were explored by using nonparametric tests, including the Wilcoxon rank test, the Mann-Whitney U test, Spearman correlations, and a linear regression and linear mixed model.

Results

One hundred ten patients were included (83% female, mean [SD] age 55.6 [12.1] years, mean [SD] RA duration 8.7 [9.5] years, 81% anti-cyclic citrullinated peptide positive). Fatigue, PROMs, and clinical, laboratory, and ultrasound variables all decreased significantly during follow-up, already at 4 weeks (P < 0.001). Fatigue was both cross-sectionally and longitudinally associated with PROMs, whereas there were no or low associations with clinical, laboratory, or ultrasound assessments of inflammation. Baseline fatigue was predictive of PROMs at 12 and 24 weeks (P < 0.05 and P < 0.001, respectively) but not of any objective assessments.

Conclusion

Fatigue was primarily associated with subjective assessments of disease activity. Thus, the present study supports fatigue to reflect other aspects of RA disease activity than inflammation.

SUBMITTER: Hammer HB

PROVIDER: S-EPMC8916557 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Fatigue Is Not Associated With Objective Assessments of Inflammation During Tocilizumab Treatment of Patients With Rheumatoid Arthritis.

Hammer Hilde Berner HB Agular Birte B Terslev Lene L

ACR open rheumatology 20211121 3

<h4>Objective</h4>In patients with rheumatoid arthritis (RA), the relation between fatigue and disease activity is not established, and our objective was to explore in post hoc analyses the associations between fatigue and subjective as well as objective assessments of inflammation during follow-up of patients with RA initiating biologic treatment.<h4>Methods</h4>In a Nordic multicenter study, patients with RA starting tocilizumab were examined for fatigue (Functional Assessment of Chronic Illne ...[more]

PMID: 34806341

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Project description:Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by joint pain, swelling, stiffness, and progressive destruction of the small joints of the hands and feet. Treatment of RA has improved over the past decade. With multiple cytokines well-known now to play a role in the pathogenesis of RA, including tumor necrosis factor alpha, interleukin (IL)-1?, and IL-6, many targeted biological treatments against these cytokines have emerged, changing the treatment of this disease. Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody against the IL-6 receptor and has been approved in many countries, including the United States, for the treatment of moderate to severe RA in patients who have not adequately responded to one or more disease-modifying antirheumatic drugs (DMARDs) or cannot tolerate other approved drug classes for RA. The aim of this review is to discuss the role of IL-6 in RA, and to provide an overview of the mode of action, pharmacokinetics, and safety of TCZ. Furthermore, efficacy studies of TCZ as both monotherapy and combination therapy will be evaluated. There have been several important clinical trials evaluating the efficacy and safety of TCZ in RA patients; this review summarizes this data from 14 key trials with emphasis on Phase III trials. Review of these trials provides strong evidence that its use, both as monotherapy and in combination with methotrexate or other DMARDs, is an effective treatment in reducing the signs and symptoms of RA. TCZ showed tolerable safety but care is required for its use since there are some important safety concerns including elevated liver enzymes, elevated low-density lipoprotein, infections, and gastrointestinal perforations. Additionally, given the efficacy of TCZ in the treatment of RA, this review discusses how TCZ may be beneficial in the treatment of other autoimmune diseases, spinal disease, cardiovascular disease, organ transplantation, and malignancies where elevated levels of IL-6 may play a role in the pathogenesis of these diseases.

Project description:BackgroundDigital biomarkers that measure physical activity and mobility are of great interest in the assessment of chronic diseases such as rheumatoid arthritis, as it provides insights on patients' quality of life that can be reliably compared across a whole population.ObjectiveTo investigate the feasibility of analyzing iPhone sensor data collected remotely by means of a mobile software application in order to derive meaningful information on functional ability in rheumatoid arthritis patients.MethodsTwo objective, active tasks were made available to the study participants: a wrist joint motion test and a walk test, both performed remotely and without any medical supervision. During these tasks, gyroscope and accelerometer time-series data were captured. Processing schemes were developed using machine learning techniques such as logistic regression as well as explicitly programmed algorithms to assess data quality in both tasks. Motion-specific features including wrist joint range of motion (ROM) in flexion-extension (for the wrist motion test) and gait parameters (for the walk test) were extracted from high quality data and compared with subjective pain and mobility parameters, separately captured via the application.ResultsOut of 646 wrist joint motion samples collected, 289 (45%) were high quality. Data collected for the walk test included 2,583 samples (through 867 executions of the test) from which 651 (25%) were high quality. Further analysis of high-quality data highlighted links between reduced mobility and increased symptom severity. ANOVA testing showed statistically significant differences in wrist joint ROM between groups with light-moderate (220 participants) versus severe (36 participants) wrist pain (p < 0.001) as well as in average step times between groups with slight versus moderate problems walking about (p < 0.03).ConclusionThese findings demonstrate the potential to capture and quantify meaningful objective clinical information remotely using iPhone sensors and represent an early step towards the development of patient-centric digital endpoints for clinical trials in rheumatoid arthritis.

Project description:BackgroundSince receiving a positive recommendation in England, Wales and Scotland, tocilizumab (TCZ) is one of the options available to clinicians for the treatment of rheumatoid arthritis (RA) patients in the UK.ObjectiveThe objective of this study was to evaluate the cost effectiveness of adding TCZ to the current treatment sequence of RA patients from a UK payer's perspective over a patient lifetime horizon.MethodsAn individual sampling model was developed to synthesise all clinical and economic inputs. Two scenarios were explored separately: patients contraindicated to methotrexate (MTX) and those MTX tolerant. For each scenario, the analysis compared three strategies. The standard of care (SoC) strategy included a sequence of the most commonly prescribed biologics; the other two comparator strategies considered the addition of TCZ to SoC at first line and second line. Patient characteristics were representative of UK patients. Treatment efficacy and quality-of-life evidence were synthesised from clinical trials and secondary sources. An analysis of a patient registry informed the model parameters regarding treatment discontinuation. The safety profile of all treatments in a given strategy was based on a network meta-analysis and literature review. Resource utilisation, treatment acquisition, administration, monitoring and adverse event treatment costs were considered. All costs reflect 2012 prices. Uncertainty in model parameters was explored by one-way and probabilistic sensitivity analysis.ResultsIn the MTX-contraindicated population, if TCZ was added to the SoC in first line, the estimated incremental cost-effectiveness ratio (ICER) was £7,300 per quality-adjusted life-year (QALY) gained; if added in second line, the estimated ICER was £11,400 per QALY. In the MTX-tolerant population, the estimated costs and QALYs of the TCZ strategy were similar to those of the SoC strategy. Sensitivity analysis showed that parameters that affect the treatment cost (such as patient weight) can have a noticeable impact on the overall cost-effectiveness results. The majority of the other sensitivity analyses resulted in modest changes to the ICER.ConclusionFor the treatment of RA in MTX-tolerant and contraindicated patients, the addition of TCZ to the SoC was estimated to be a cost-effective strategy.

Dataset Information

Fatigue Is Not Associated With Objective Assessments of Inflammation During Tocilizumab Treatment of Patients With Rheumatoid Arthritis.

Objective

Methods

Results

Conclusion

Publications

Fatigue Is Not Associated With Objective Assessments of Inflammation During Tocilizumab Treatment of Patients With Rheumatoid Arthritis.

Similar Datasets

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