scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

Effect of Golimumab on Patient-reported Outcomes in Rheumatoid Arthritis: Results from the GO-FORWARD Study

2012 ◽  
Vol 39 (6) ◽  
pp. 1185-1191 ◽  
Author(s):  
MARK C. GENOVESE ◽  
CHENGLONG HAN ◽  
EDWARD C. KEYSTONE ◽  
ELIZABETH C. HSIA ◽  
JACQUELINE BUCHANAN ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Physical Function ◽  
General Health ◽  
Short Form ◽  
Health Assessment ◽  
Medical Outcomes ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Questionnaire Disability

Objective.To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.Methods.In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.Results.Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.Conclusion.Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550)

scholarly journals P158 Severity of hand vascular involvement as assessed by MRI Digital Artery Volume Index (DAVIX©) predicts worsening of clinical parameters and patient reported outcomes in scleroderma

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Fiammetta Danzo ◽  
Klodian Gjeloshi ◽  
Giovanni Lettieri ◽  
Giuseppina Abignano ◽  
Mark Hinton ◽  
...  
Keyword(s):  
Disease Activity ◽  
Health Assessment Questionnaire ◽  
Patient Reported Outcomes ◽  
Health Assessment ◽  
Volume Index ◽  
Vascular Involvement ◽  
Clinical Parameters ◽  
Digital Artery ◽  
Patient Reported ◽  
Assessment Questionnaire

Abstract Background Neointima proliferation is a key pathologic feature of systemic sclerosis (SSc), causing arterial vessel narrowing and being the recognised culprit pathological lesion in digital ulcers (DUs), pulmonary artery hypertension and renal crisis. Nevertheless, there are no validated imaging techniques to assess the severity of vascular involvement in SSc. We have previously shown digital artery volume index (DAVIX©) assessed with time of right MRI angiography, is a reliable measure of neointima proliferation in the hands. The purpose of our study was to identify the value of DAVIX© in predicting worsening of patient reported outcomes (PROs) and clinical parameters in SSc. Methods Cross-sectional data were available for 91 patients and complete 12 months follow-up data for 68 patients. Data collected included: modfied Rodnan skin score (mRSS), pulmonary function tests (PFTs), echocardiography, nailfold capillaroscopy, Health Assessment Questionnaire Disability Index (HAQ-DI), and Scleroderma Health Assessment Questionnaire (sHAQ). DAVIX© of the dominant hand was calculated as the % mean of the 4 fingers, employing MeVisLab software. Following analysis of distribution, Spearman or Pearson test were used to determine correlation coefficients, as appropriate (Prism 7). Results 56/68 were female and median of disease duration was 4 years (IQR 1.91-9). As previously reported DAVIX© correlated with the presence of DUs (p = 0.0093). Considering all patients, DAVIX© correlated with mRSS (r=-0.258, p = 0.017), DLCO% (r = 0.338, p = 0.008) and the pattern of capillaroscopy (r=-0.388, p = 0.001). In patients with DUs, DAVIX© showed a stronger correlation with DLCO% (r = 0.786, p = 0.048). Most importantly, DAVIX© predicted the worsening of HAQ-DI (r=-0.295, p = 0.029), sHAQ (r =-0.333, p = 0.029) and VAS pain (r=-0.269, p = 0.038) independently of the presence of DUs. Conclusion The quantitative assessment of neointima proliferation in the hand by DAVIX© is a useful imaging biomarker of vascular disease activity. The value of DAVIX© in predicting the worsening of PROs and clinical parameters in overall patients, may offer insights on the role of vascular disease activity in the global progression of SSc. The validation of our data in an independent cohort and the sensitivity to change over time of DAVIX© may aid to the implementation of hand MRI as imaging outcome measure of vascular severity in SSc. Disclosures F. Danzo None. K. Gjeloshi None. G. Lettieri None. G. Abignano None. M. Hinton None. A. Dean None. G. Cuomo None. O. Kubassova None. F. del Galdo None.

Measuring physical function in psoriatic arthritis: comparing the Multi-Dimensional Health Assessment Questionnaire to the Health Assessment Questionnaire Disability Index

2021 ◽  
pp. jrheum.200927
Author(s):  
Weiyu Ye ◽  
Simon Hackett ◽  
Claire Vandevelde ◽  
Sarah Twigg ◽  
Philip S. Helliwell ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Physical Function ◽  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
Clinic Visit ◽  
Retest Reliability ◽  
Floor Effects ◽  
Test Retest Reliability ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Objective To compare physical function scales of the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) to the Health Assessment Questionnaire Disability Index (HAQDI) in patients with psoriatic arthritis (PsA), and examine whether either questionnaire is less prone to ‘floor effects’. Methods Data were collected prospectively from 2018 to 2019 across three UK hospitals. All patients completed physical function scales within the MDHAQ and HAQDI in a single clinic visit. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. Results 210 patients completed the clinic visit; one withdrew consent thus 209 were analysed. 60.0% were male, with mean age of 51.7 years and median disease duration of 7 years. In clinic, median MDHAQ and HAQDI including/excluding aids scores were 0.30, 0.50 and 0.50 respectively. Although the median score for HAQDI is higher than MDHAQ, the difference between the two mostly lies within 1.96 standard deviations from the mean suggesting good agreement. The ICCs demonstrated excellent test-retest reliability for both HAQ questionnaires.Similar numbers of patients scored ‘0’ on the MDHAQ and HAQDI including/excluding aids (48, 47, and 49 respectively). Using a score of ≤0.5 as a cut-off for minor functional impairment, 23 patients had a MDHAQ ≤0.5 when their HAQDI including aids >0.5. Conversely, 4 patients had a MDHAQ > 0.5 when the HAQDI including aids ≤0.5. ConclusionBoth HAQ questionnaires appear to be similar in detecting floor effects in patients with PsA.

scholarly journals Validating and Assessing the Sensitivity of the Health Assessment Questionnaire-Disability Index-derived Short Form-6D in Patients with Early Aggressive Rheumatoid Arthritis

2009 ◽  
Vol 36 (6) ◽  
pp. 1150-1157 ◽  
Author(s):  
SOGOL S. AMJADI ◽  
PAUL M. MARANIAN ◽  
HAROLD E. PAULUS ◽  
ROBERT M. KAPLAN ◽  
VEENA K. RANGANATH ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Construct Validity ◽  
Health Assessment Questionnaire ◽  
Short Form ◽  
Health Assessment ◽  
Correlation Coefficients ◽  
Patient Reported ◽  
Clinical Measures ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Objective.New methodologies allow the scores for the Health Assessment Questionnaire-Disability Index (HAQ-DI) to be translated into preferences/utility scores. We evaluated the construct validity of the HAQ-DI-derived Short Form-6D (SF-6D) score and assessed its responsiveness to change over 6- and 12-month followup periods in patients with early aggressive rheumatoid arthritis (RA).Methods.Patients (n = 277) participating in an RA observational study completed self-reported measures of symptoms and the HAQ-DI at baseline and at 6 and 12 months. Total Sharp scores, C-reactive protein, and erythrocyte sedimentation rate were assessed along with clinical data. Construct validity was assessed by examining the association between SF-6D score and patient-reported and clinical measures using Spearman correlation coefficients. The responsiveness of SF-6D to change was assessed using patient and physician assessments of the disease as clinical anchors. The magnitude of responsiveness was calculated using SF-6D effect size (ES).Result.Mean SF-6D scores were 0.690, 0.720, and 0.723 at baseline and 6 and 12-month followup, respectively. Baseline patient-reported measures had moderate to high correlations with baseline SF-6D (r = 0.43 to 0.52); whereas clinical measures had negligible to low correlations with SF-6D (r = 0.001 to 0.32). ES was moderate for the groups that were deemed to have improved (ES 0.63–0.75) but negligible to small for those that did not (ES 0.13–0.46).Conclusion.Our data support the validity and responsiveness of the HAQ-DI derived SF-6D score in an early RA cohort. These results support the use of the HAQ-DI derived SF-6D in RA cohorts and clinical trials lacking preference-based measures.

Progress in Assessing Physical Function in Arthritis: PROMIS Short Forms and Computerized Adaptive Testing

2009 ◽  
Vol 36 (9) ◽  
pp. 2061-2066 ◽  
Author(s):  
JAMES F. FRIES ◽  
DAVID CELLA ◽  
MATTHIAS ROSE ◽  
ESWAR KRISHNAN ◽  
BONNIE BRUCE
Keyword(s):  
Physical Function ◽  
Health Assessment Questionnaire ◽  
Computerized Adaptive Testing ◽  
Health Assessment ◽  
Adaptive Testing ◽  
Superior Performance ◽  
Short Forms ◽  
Improve Measurement ◽  
Patient Reported ◽  
Assessment Questionnaire

Objective.Assessing self-reported physical function/disability with the Health Assessment Questionnaire Disability Index (HAQ) and other instruments has become central in arthritis research. Item response theory (IRT) and computerized adaptive testing (CAT) techniques can increase reliability and statistical power. IRT-based instruments can improve measurement precision substantially over a wider range of disease severity. These modern methods were applied and the magnitude of improvement was estimated.Methods.A 199-item physical function/disability item bank was developed by distilling 1865 items to 124, including Legacy Health Assessment Questionnaire (HAQ) and Physical Function-10 items, and improving precision through qualitative and quantitative evaluation in over 21,000 subjects, which included about 1500 patients with rheumatoid arthritis and osteoarthritis. Four new instruments, (A) Patient-Reported Outcomes Measurement Information (PROMIS) HAQ, which evolved from the original (Legacy) HAQ; (B) “best” PROMIS 10; (C) 20-item static (short) forms; and (D) simulated PROMIS CAT, which sequentially selected the most informative item, were compared with the HAQ.Results.Online and mailed administration modes yielded similar item and domain scores. The HAQ and PROMIS HAQ 20-item scales yielded greater information content versus other scales in patients with more severe disease. The “best” PROMIS 20-item scale outperformed the other 20-item static forms over a broad range of 4 standard deviations. The 10-item simulated PROMIS CAT outperformed all other forms.Conclusion.Improved items and instruments yielded better information. The PROMIS HAQ is currently available and considered validated. The new PROMIS short forms, after validation, are likely to represent further improvement. CAT-based physical function/disability assessment offers superior performance over static forms of equal length.

Characterization of patients with chronic refractory gout who do and do not have clinically apparent tophi and their response to pegloticase

Rheumatology ◽  
2019 ◽  
Vol 58 (8) ◽  
pp. 1422-1431 ◽  
Author(s):  
N Lawrence Edwards ◽  
Jasvinder A Singh ◽  
Orrin Troum ◽  
Anthony E Yeo ◽  
Peter E Lipsky
Keyword(s):  
Health Assessment Questionnaire ◽  
Global Assessment ◽  
Short Form ◽  
Bodily Pain ◽  
Health Assessment ◽  
Serum Urate ◽  
Patient Global Assessment ◽  
Short Form 36 ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Abstract Objective To determine the characteristics and response to pegloticase of patients with chronic refractory gout with and without clinically apparent tophi. Methods Results from two randomized controlled trials of pegloticase in patients with chronic refractory gout with clinically apparent tophi or without tophi were used to assess baseline and on-treatment between-group differences. Results Patients with tophi were significantly older than those without tophi, had a significantly longer duration of disease, higher numbers of tender and swollen joints, higher Patient Global Assessment scores and Health Assessment Questionnaire-Disability Index scores, and lower Arthritis-Specific Health Index scores. Patients with tophaceous gout also had significantly lower scores for physical functioning, role physical, social functioning, and the physical component summary scores of the Short Form 36 vs patients without tophi. In addition, subjects with clinically apparent tophi had a significantly lower mean estimated glomerular filtration rate. Pegloticase treatment of tophaceous patients caused significant reductions in serum urate, flares, Patient Global Assessment, tender joints, swollen joints, Health Assessment Questionnaire-Disability Index, visual analogue scale pain and Short Form 36 Bodily Pain, whereas patients without tophi had significant improvement in serum urate, flares, Patient Global Assessment, tender joints, and Short Form 36 Bodily Pain, but not swollen joints, Health Assessment Questionnaire-Disability Index functional score or pain visual analogue scale. Treatment with pegloticase had no effect on estimated glomerular filtration rate despite significant lowering of the urinary uric acid: creatinine ratio. Conclusion Patients with chronic refractory gout and clinically apparent tophi have more severe disease as well as reduced renal function. Both groups experienced significant clinical benefit with pegloticase treatment, although no change in renal function was noted.

scholarly journals Patient Reported Outcomes of Tenodesis to Reconstruct Peroneal Tendon Tears

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0019
Author(s):  
Natalie Danna ◽  
James Rizkalla ◽  
Ermias Abebe ◽  
James Brodsky
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Treatment Algorithm ◽  
Measurement Tool ◽  
Peroneal Tendon ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Tendon Tears ◽  
One Year

Category: Ankle Introduction/Purpose: Peroneal tendon tears are a common cause of lateral ankle pain. When the tear involves more than 50% of the tendon’s cross-sectional area, the treatment algorithm recommends tenodesis of the torn peroneal tendon to the intact peroneal tendon. Previous assessments in the literature of functional outcomes after peroneal tenodesis have widely used the American Orthopedic Foot and Ankle Score (AOFAS) survey as a measurement tool. However, this score was not designed for patient-reported outcomes and its validity and reliability have been questioned. The Medical Outcomes Shortform-36 (SF-36) and PROMIS are tools that have been extensively studied and validated. We sought to assess patient outcomes after peroneal tenodesis using validated tools: SF-36, PROMIS and AOS Disability scores. Methods: Prospective data was collected on patients undergoing peroneal tenodesis for peroneal tendon tears, and who follow up of at least one year. Patients who underwent concomitant procedures (hindfoot fusion, total ankle arthroplasty) were excluded from the study. Baseline patient-reported outcomes (PRO) scores were obtained preoperatively and compared to scores obtained at one year postoperatively. Results: We identified seventeen patients who underwent peroneal tenodesis for peroneal tendon tears. Average age was 62.1 years. SF-36 Physical Function scores increased from an average of 42.0 preop to 60.0 postop (p = 0.0095). PROMIS scores increased from 40.3 to 42.7 (p = 0.3049). There was no statistically significant improvement in postoperative SF-36 Pain scores (p = 0.3216). AOS Disability Scores dropped from 49.6 preop to 38.2 postop (p = 0.3178). AOS Pain scores decreased from 40.7 to 27.0 (p = 0.1779). Total AOS score decreased from 45.1 to 32.6 (p = 0.2204). Conclusion: The SF-36 Physical Function score, which is a validated outcome measure, showed statistically significant improvement postoperatively. Some of the other PROs for peroneal tenodesis failed to show statistically significant improvements, and this is most likely due to low numbers, rendering the cohort somewhat under-powered. Though the data is preliminary, the non-significant scores trended toward improvement. Despite the preliminary nature of this study, satisfactory outcomes of peroneal tenodesis using validated patient-reported outcome scores are demonstrated for the first time. Further study is underway to enlarge the scope of this investigation.

scholarly journals Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Janet Pope ◽  
Namita Tundia ◽  
Alan Friedman ◽  
Heidi S. Camp ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Normative Values ◽  
Number Needed To Treat ◽  
Inadequate Response ◽  
Mixed Effect ◽  
Meaningful Improvement ◽  
Sf 36 ◽  
Patient Reported

Abstract Background To evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs. Methods Patients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests. Results Data from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients. Conclusions Upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA. Trial registration Clinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.

scholarly journals Physical Function Assessment of a Mayan Population Living With Osteoarthritis: The Importance of Considering Different Aspects of Functioning

2017 ◽  
Vol 6 ◽  
pp. 117957271771543 ◽  
Author(s):  
Adalberto Loyola-Sanchez ◽  
Julie Richardson ◽  
Ingris Pelaez-Ballestas ◽  
Jose Alvarez-Nemegyei ◽  
John N Lavis ◽  
...  
Keyword(s):  
Physical Function ◽  
Leisure Activities ◽  
Health Assessment ◽  
Self Report ◽  
American College Of Rheumatology ◽  
Mild Disability ◽  
Experimental Function ◽  
6 Minute Walk Test ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Objectives: To assess the physical function of people living with osteoarthritis in a Maya-Yucateco rural community from 3 perspectives and explore factors associated with the presence of disability. Design: Physical function and social, physical, psychological, and behavioral factors were evaluated in all adults detected with hand, hip, and/or knee osteoarthritis (n = 144) through a Community-Oriented Program for the Control of Rheumatic Diseases–based census in the Mayan community of Chankom, Yucatán. All cases fulfilled the American College of Rheumatology criteria. Physical function was assessed from 3 perspectives: hypothetical or “what people think they can do” (Health Assessment Questionnaire-Disability Index [HAQ-DI]), experimental or “what people could do in standardized conditions” (6-minute walk test [6MWT] + the Functional Dexterity Test) and enacted or “what people actually do” (personal care, work, and leisure activities’ self-report). Results: About 80% of participants reported “mild” disability (HAQ-DI ≤ 1) in the hypothetical function perspective, whereas average experimental function scores were low (6MWT: 206 m, Functional Dexterity Test: 64 seconds), and 78% of participants reported problems with enacted function (ie, work). Pain was significantly associated with disability in the hypothetical perspective (odds ratio [OR] = 3 [95% confidence interval [CI]: 1-4]); levels of wealth (β = 5 [95% CI: 1-9]) and muscle strength (β = 54 [95% CI: 20-87]) were significantly associated with functioning in the experimental perspective; and lower levels of self-efficacy (OR = 12 [95% CI: 6-27]) and physical activity (OR = 12 [95% CI: 6-27]) were significantly associated with work disability in the enacted function perspective. Conclusions: People living with osteoarthritis in Chankom show important issues when assessing physical function at the experimental and enacted perspectives, which could have been overlooked if only the hypothetical perspective was considered. Different factors were associated with different physical function perspectives and all should be addressed to decrease disability in this community.

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