scholarly journals Treatment response and several patient-reported outcomes are early determinants of future self-efficacy in rheumatoid arthritis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Doumen Michaël ◽  
De Cock Diederik ◽  
Pazmino Sofia ◽  
Bertrand Delphine ◽  
Joly Johan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Treatment Response ◽  
Self Efficacy ◽  
Global Assessment ◽  
Patient Reported Outcomes ◽  
Self Management ◽  
Remission Induction ◽  
Early Ra ◽  
Sf 36 ◽  
Patient Reported

Abstract Background Self-efficacy, or patients’ confidence in their ability to control disease and its consequences, was recently prioritised in EULAR recommendations for inflammatory arthritis self-management strategies. However, it remains unclear which factors influence self-efficacy in early rheumatoid arthritis (RA). Methods Data were analysed from the 2-year RCT Care in early RA (CareRA), which studied remission-induction treatment regimens for early RA. Participants completed the Arthritis Self-Efficacy Scale (ASES), Short-Form 36 (SF-36), Revised Illness Perception Questionnaire (IPQ-R), Utrecht Coping List (UCL), RAQoL and Health Assessment Questionnaire (HAQ). Depending on time to first remission (DAS28-CRP < 2.6) and persistence of remission, treatment response was defined as persistent response, secondary failure, delayed response, late response or non-response. The association between ASES scores and clinical/psychosocial factors was explored with Spearman correlation and multivariate linear mixed models. Baseline predictors of week 104 ASES were identified with exploratory linear regression followed by multiple regression of significant predictors adjusted for DAS28-CRP, HAQ, treatment arm, treatment response, cumulative CRP/SJC28 and demographic/serologic confounders. Results All 379 patients had a recent diagnosis of RA and were DMARD-naïve at study initiation. Most patients were women (69%) and RF/ACPA-positive (66%), and the mean (SD) age was 52 (13) years. For all tested outcome measures, better perceived health correlated with higher self-efficacy. While patient-reported factors (HAQ, SF-36, RAQoL, IPQ-R, pain, fatigue and patient’s global assessment) showed moderate/strong correlations with ASES scores, correlations with physician-reported factors (physician’s global assessment, SJC28), TJC28 and DAS28-CRP were weak. Only more favourable outcomes on patient-reported factors and DAS28-CRP were associated with higher ASES scores at each time point. An earlier, persistent treatment response predicted higher ASES scores at both weeks 52 and 104. Significant baseline predictors of week 104 ASES included HAQ; SF-36 mental component score, vitality, mental health and role emotional; IPQ-R illness coherence, treatment control, emotional representations and consequences; UCL Passive reacting; and the RAQoL. Conclusions Patient-reported outcomes and treatment response were early determinants of long-term self-efficacy in an early RA trial. These results provide further relevance for the window of opportunity in an early treat-to-target strategy and could help to timely identify patients who might benefit from self-management interventions. Trial registration EudraCT 2008-007225-39

scholarly journals Correction to: Treatment response and several patient-reported outcomes are early determinants of future self-efficacy in rheumatoid arthritis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Michaël Doumen ◽  
Diederik De Cock ◽  
Sofia Pazmino ◽  
Delphine Bertrand ◽  
Johan Joly ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Treatment Response ◽  
Self Efficacy ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Future Self

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Pain Score ◽  
Patient Reported Outcomes ◽  
Component Score ◽  
Link Type ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

scholarly journals POS1455-HPR RELATIONSHIP BETWEEN PSYCHOLOGICAL FACTORS AND MEASURES OF RHEUMATOID ARTHRITIS ACTIVITY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1011.2-1011
Author(s):  
Y. Olyunin ◽  
V. Rybakova ◽  
E. Likhacheva ◽  
E. Nasonov
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Psychological Factors ◽  
Global Assessment ◽  
Activity Level ◽  
Anxiety And Depression ◽  
Tender Joint Count ◽  
Sf 36 ◽  
Patient Reported

Background:The patient-reported outcomes are important components of quantitative methods of rheumatoid arthritis (RA) activity assessment which are used to choose the appropriate drug therapy. The value of these parameters can be significantly affected not only by the inflammatory process, but also by the psychological characteristics of the patient and, in particular, by hardiness [1].Objectives:To study the relationship between psychological factors and signs of RA activity.Methods:Patients with RA who met the EULAR/ACR 2010 criteria, and observed at the V. A. Nasonova Research Institute of Rheumatology were included. Clinical examination was performed including patient global assessment (PGA), physician global assessment (PhGA), pain measurement on a visual analog scale, tender joint count (TJC), swollen joint count (SJC). The functional status was determined by HAQ, the quality of life – by SF-36 EQ-5D, the nature of pain – by painDETECT, the presence of anxiety and depression – by HADS. Patients also completed Hardiness Survey questionnaire to assess hardiness (HDS) and 3 components of the HDS – commitment (CMT), control (CT) and challenge (CLN). Disease activity was evaluated with DAS28, CDAI, and RAPID3. All patients signed informed consent to participate in the study. Analysis of the data was performed using Spearman’s rank test, Fisher exact test, qui-square and t-tests.Results:85 patients with RA were included. There were 69 women and 16 men. Mean age was 56.7±13.1 years, disease duration – 7.6±2.7 years. 72 patients were positive for rheumatoid factor, 75 – for anti-cyclic citrullinated peptide antibody. CDAI showed high activity in 15, moderate – in 37, low – in 30, and remission in 3 patients, DAS 28 – in 10, 55, 12, and 8, and RAPID3 – in 24, 25, 15, and 21, respectively. 24 patients had subclinically or clinically expressed anxiety and 15 –subclinically or clinically expressed depression (≥8 according to HADS). In 31 patients, the painDETECT questionnaire revealed possible or probable neuropathic pain. Mean HDS was 84.8±21.7, CMT – 38.9±9.2, CT – 29.4±8.6, CLN – 17.3±7.1. These values were comparable with the corresponding population data for this age group. There was a significant inverse correlation between HDS and RA activity measures, including SJC, TJC, DAS28 (p<0.05), pain, PGA, PhGA, CDAI, RAPID3, and HAQ (p<0.01). In addition, HDS and all its components positively correlated with quality of life, assessed by SF-36 and EQ-5D (p<0.01). In patients with subclinically and clinically expressed anxiety and depression, HDS, CMT, and CT were significantly lower than in patients without anxiety and depression (p<0.01), while the values of CLN in these groups did not differ significantly.Conclusion:The results of the present study suggest that low HDS may be one of the significant factors determining RA activity level because it does not allow patients to adapt adequately to a stressful situation produced by the disease.References:[1]Maddi SR. Am Psychol. 2008 Sep;63(6):563-4.Disclosure of Interests:None declared

scholarly journals Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001040 ◽  
Author(s):  
Vibeke Strand ◽  
Eduardo Mysler ◽  
Robert J Moots ◽  
Gene V Wallenstein ◽  
Ryan DeMasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Link Type ◽  
Combination Treatments ◽  
Sf 36 ◽  
Patient Reported ◽  
Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

scholarly journals Secular changes in the progression of clinical markers and patient-reported outcomes in early rheumatoid arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2381-2391 ◽  
Author(s):  
Lewis Carpenter ◽  
Elena Nikiphorou ◽  
Patrick D W Kiely ◽  
David A Walsh ◽  
Adam Young ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Visual Analogue Scale ◽  
Early Rheumatoid Arthritis ◽  
Analogue Scale ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Clinical Markers ◽  
Short Form 36 ◽  
Early Ra ◽  
Patient Reported

Abstract Objectives To examine secular trends in the progression of clinical and patient-reported outcomes in early RA. Methods A total of 2701 patients recruited to the Early Rheumatoid Arthritis Study or Early Rheumatoid Arthritis Network with year of diagnosis from 1986 to 2011. The 5-year progression rates for patients diagnosed at different points in time were modelled using mixed-effects regression; 1990, 2002 and 2010, were compared. Clinical markers of disease included the 28-joint count DAS and the ESR. Patient-reported markers included the HAQ, visual analogue scale of pain and global health, and the Short-Form 36. Results Statistically significant improvements in both 28-joint count DAS and ESR were seen over the 5 years in patients diagnosed with RA compared with those diagnosed earlier. By 5 years, 59% of patients with diagnosis in 2010 were estimated to reach low disease activity compared with 48% with diagnosis in 2002 and 32% with diagnosis in 1990. Whilst HAQ demonstrated statistically significant improvements, these improvements were small, with similar proportions of patients achieving HAQ scores of ≤1.0 by 5 years with a diagnosis in 1990 compared with 2010. Levels of the visual analogue scale and the Mental Component Scores of the Short-Form 36 indicated similar, statistically non-significant levels over the 5 years, irrespective of year diagnosed. Conclusion This study demonstrates improvements in inflammatory markers over time in early RA, in line with improved treatment strategies. These have not translated into similar improvements in patient-reported outcomes relating to either physical or mental health.

scholarly journals Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study

2017 ◽  
Vol 76 (11) ◽  
pp. 1853-1861 ◽  
Author(s):  
Edward C Keystone ◽  
Peter C Taylor ◽  
Yoshiya Tanaka ◽  
Carol Gaich ◽  
Amy M DeLozier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Joint Pain ◽  
Patient Reported Outcomes ◽  
Physical Component Score ◽  
Study Endpoint ◽  
Primary Study ◽  
Inadequate Response ◽  
Phase 3 ◽  
Sf 36 ◽  
Patient Reported

BackgroundTo assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).MethodsIn this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity (PtGA), patient’s assessment of pain and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables.ResultsCompared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p≤0.05).ConclusionsBaricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52).Trial registrationNCT01710358.

scholarly journals Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Michael Schiff ◽  
Namita Tundia ◽  
Alan Friedman ◽  
Sebastian Meerwein ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Normative Values ◽  
Number Needed To Treat ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Sf 36 ◽  
Patient Reported ◽  
Disease Modifying

Abstract Background Patient-reported outcomes (PROs) are important when evaluating treatment benefits in rheumatoid arthritis (RA). We compared upadacitinib, an oral, selective JAK-1 inhibitor, with placebo to assess clinically meaningful improvements in PROs in patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR). Methods PRO responses between upadacitinib 15 mg or 30 mg and placebo were evaluated at week 12 from the SELECT-BEYOND trial. Improvement was determined by measuring Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI). Least squares mean changes and percentage of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores greater than or equal to normative values were determined. The number needed to treat (NNT) to achieve clinically meaningful improvements was calculated. Results In 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity. Compared with placebo, more upadacitinib-treated patients reported improvements ≥ MCID in PtGA, pain, HAQ-DI, SF-36 PCS, 7 of 8 SF-36 domains (15 mg), 5 of 8 SF-36 domains (30 mg), AM stiffness duration and severity, and ISI (30 mg) and scores ≥ normative values in HAQ-DI and SF-36 domains. Across most PROs, NNTs to achieve MCID with upadacitinib ranged from 4 to 7 patients. Conclusions In bDMARD-IR RA patients, upadacitinib (15 mg or 30 mg) improved multiple aspects of quality of life, and more patients reached clinically meaningful improvements approaching normative values compared with placebo. Trial registration The trial is registered with ClinicalTrials.gov (NCT02706847), registered 6 March 2016.

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