scholarly journals Clinical and Psychological Assessment of Patients With Rheumatoid Arthritis and Fibromyalgia

2021 ◽  
Author(s):  
Chao Gao ◽  
Hua Zhong ◽  
Lihong Chen ◽  
Li Wang ◽  
Hong Yao ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Short Form ◽  
Health Assessment ◽  
Depression Scale ◽  
Psychological Status ◽  
Tender Joint ◽  
Das 28 ◽  
Sf 36 ◽  
Peking University

Abstract ObjectiveThis study aimed to assess the clinical features as well as the functional and psychological status of patients with rheumatoid arthritis and fibromyalgia in a real-world setting in China.MethodsA total of 202 inpatients with rheumatoid arthritis from the Department of Rheumatology and Immunology at Peking University People’s Hospital were enrolled between December 2018 and April 2019. These inpatients were assessed for the presence of fibromyalgia using the 1990 American College of Rheumatology’s classification criteria for fibromyalgia. Disease activity and functional and psychological status were assessed using the Disease Activity Score in 28 Joints (DAS-28), Short Form-36 health survey questionnaire (SF-36), Health Assessment Questionnaire (HAQ), Hospital Anxiety and Depression Scale, and Visual Analog Scale.ResultsOf 202 patients with rheumatoid arthritis, 42 (20.8%) had concurrent fibromyalgia. Compared to patients without fibromyalgia, those with rheumatoid arthritis and fibromyalgia had higher DAS-28 scores (6.0 vs. 4.4, P=0.011) and notably higher tender joint counts (16.5 vs. 4.5, P<0.001). Patients with rheumatoid arthritis and fibromyalgia had worse HAQ scores (1.24 vs. 0.66, P<0.001) and lower SF-36 scores (28.6 vs. 58.2, P<0.001). Additionally, patients with rheumatoid arthritis and fibromyalgia experienced more fatigue (88.1% vs. 50.6%, P<0.001) and had higher anxiety (10 vs. 4, P<0.001) and depression scores (12 vs. 6, P<0.001). No significant differences in erythrocyte sedimentation rate, C-reactive protein concentration, morning stiffness period, or swollen joint counts were identified between the groups.ConclusionsPatients with rheumatoid arthritis and fibromyalgia had higher disease activity, worse functional and psychological status, and poorer quality of life. DAS-28 scores may have been overestimated in these patients. When patients with rheumatoid arthritis do not achieve remission, the possibility of fibromyalgia should be considered.

scholarly journals Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000742 ◽  
Author(s):  
Paul Bird ◽  
Stephen Hall ◽  
Peter Nash ◽  
Carol A Connell ◽  
Kenneth Kwok ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Physical Functioning ◽  
Short Form ◽  
Health Assessment ◽  
Response Rates ◽  
Phase Iii ◽  
Link Type ◽  
Chronic Illness Therapy ◽  
Sf 36

ObjectivesTofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). We examined response to tofacitinib 5 or 10 mg two times a day in patients with seropositive vs seronegative RA.MethodsData were pooled from five Phase III studies of conventional synthetic disease-modifying antirheumatic drug (csDMARD)- or biological DMARD-inadequate responders (ORAL Step [NCT00960440]; ORAL Scan [NCT00847613]; ORAL Solo [NCT00814307]; ORAL Sync [NCT00856544]; ORAL Standard [NCT00853385]). ‘Serotype’ subgroups were: anticyclic citrullinated peptide (CCP) and rheumatoid factor (RF) positive (anti-CCP+/RF+); anti-CCP+/RF negative (-); anti-CCP-/RF+; anti-CCP-/RF-. At month 3, ACR20/50/70 response rates, Disease Activity Score (DAS28-4[ESR])-defined remission (DAS28-4[ESR]<2.6) and low disease activity (LDA; DAS28-4[ESR]≤3.2), changes from baseline (CFB) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36) physical functioning and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Safety endpoints were compared.ResultsBaseline demographics/characteristics were similar across subgroups. Tofacitinib significantly improved ACR20/50/70 response rates, DAS28-4(ESR) LDA rates and CFB in HAQ-DI and FACIT-F vs placebo across subgroups. More anti-CCP+/RF+ than anti-CCP-/RF- patients had ACR20/50/70 responses (ACR20/50: both tofacitinib doses; ACR70: 10 mg two times a day). SF-36 physical functioning improved in anti-CCP+/RF+, anti-CCP+/RF- and anti-CCP-/RF+ patients (both tofacitinib doses) and anti-CCP-/RF- patients (10 mg two times a day) vs placebo. More anti-CCP+/RF+ and anti-CCP+/RF- than anti-CCP-/RF- patients achieved DAS28-4(ESR) remission and LDA with tofacitinib 10 mg two times a day. Frequency of adverse events (AEs), serious AEs and discontinuations due to AEs were similar across subgroups.ConclusionGenerally, tofacitinib efficacy (ACR20/50/70 responses) and safety were similar across subgroups. DAS28-4(ESR) remission rates and SF-36 physical functioning appeared lower in anti-CCP- patients.

scholarly journals P128 A subgroup analysis of the efficacy of filgotinib for patients with moderately active RA following an inadequate response to methotrexate

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Maya H Buch ◽  
David Walker ◽  
Patrick D W Kiely ◽  
Christopher J Edwards ◽  
Jane Barry ◽  
...  
Keyword(s):  
Disease Activity ◽  
Short Form ◽  
Health Assessment ◽  
Physical Component Score ◽  
Inadequate Response ◽  
Research Support ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Moderate Disease ◽  
Sf 36

Abstract Background/Aims  Filgotinib is an oral, preferential janus kinase 1 inhibitor. FINCH 1 (NCT02889796) was a phase III, double-blind, placebo- and active-controlled study evaluating filgotinib efficacy and safety in patients with rheumatoid arthritis (RA) after inadequate response to methotrexate (MTX; MTX-IR). Methods  MTX-IR patients with moderately or severely active RA were randomised (3:3:2:3) to filgotinib 200 mg daily, filgotinib 100 mg daily, adalimumab 40 mg every 2 weeks, or placebo on a background of stable MTX for up to 52 weeks. An exploratory subgroup analysis of FINCH 1 was conducted in patients with moderately active RA based on Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP])&gt;3.2-≤5.1 at baseline. Proportion of patients achieving 20%/50%/70% improvement from baseline in American College of Rheumatology core criteria (ACR20/50/70), DAS28(CRP)≤3.2, DAS28(CRP)&lt;2.6, change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Physical Component Score (SF-36 PCS), patient-reported pain, and modified total Sharp/van der Heijde score (mTSS) were assessed at week (W)12 and W24. All analyses were exploratory without multiplicity adjustment; nominal P-values are reported. Results  Of 1,755 treated patients, 24% had moderate disease at baseline with similar proportions (21.9%-26.9%) across treatment groups. In each treatment arm, baseline characteristics were well balanced for the moderate disease activity subpopulation. The majority (77%) were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.7) years; mean (SD) baseline DAS28(CRP) was 4.6 (0.42). At W12 and W24, proportions achieving ACR20/50/70, DAS28(CRP)&lt;2.6, and DAS28(CRP)≤3.2 were significantly higher for both filgotinib doses relative to placebo (Table). Improvement in HAQ-DI was significantly greater vs placebo at W12 but not W24 for both filgotinib doses (Table 1). For both doses of filgotinib vs placebo, SF-36 PCS and pain were significantly improved and there was numerically less radiographic progression as assessed by mTSS at W12 and W24 (Table). Composite disease activity, HAQ-DI, and mTSS scores with both filgotinib doses were comparable to adalimumab. P128 Table 1:Efficacy outcomes at week 12 and week 24Week 12Week 24FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)ACR2077.9***67.8***65.343.872.1**75.2***68.154.7ACR5043.3***37.2***41.716.452.9***47.1**56.930.5ACR7019.2***17.4***15.33.932.7***29.8**29.213.3DAS28 (CRP)&lt;2.647.1***37.2***44.415.661.5***46.3***50.023.4DAS28 (CRP)≤3.267.3***63.6***66.739.174.0***73.6***62.549.2ΔHAQ-DI−0.51a,***−0.40b,*−0.47c−0.28d−0.57e−0.53f−0.65g−0.48hΔmTSS0.02i0.06j0.03k0.16l−0.04m,*0.11n−0.01o0.21pΔSF-36 PCS7.8q,***6.4r,***7.0s3.7t8.8u,**7.2v,*9.5w5.8xΔPain, mm−24***−23***−23−12−28***−28***−28−21***P&lt;0.001 vs PBO;**P&lt;0.01 vs PBO;*P&lt;0.05 vs PBO; all P-values are nominal. Binary efficacy endpoints were compared between FIL and PBO using Fisher's exact test. Comparisons of change from baseline between FIL vs PBO were conducted using mixed-effects models for repeated measures including treatment group, visit, treatment group by visit, baseline value as fixed effects, and subjects as random effect.an = 98;bn = 114;cn = 67;dn = 117;en = 89;fn = 108;gn = 61;hn = 100;in = 94;jn = 113;kn = 62;ln = 112;mn = 89;nn = 105;on = 60;pn = 97;qn = 99;rn = 116;sn = 67;tn = 118;un = 91;vn = 109;wn = 62;xn = 100.ΔHAQ-DI, change from baseline in Health Assessment Questionnaire-Disability Index; ΔmTSS, change from baseline in modified total Sharp/van der Heijde score; ΔSF-36 PCS, change from baseline in Short Form-36 Physical Component Score; ACR, American College of Rheumatology; ADA, adalimumab; DAS28(CRP), Disease Activity Score in 28 joints with C-reactive protein; FIL, filgotinib; PBO, placebo. Conclusion  In a subgroup of patients from FINCH 1 with baseline moderately active RA, significantly greater improvements in disease activity were observed with both filgotinib doses over placebo and associated with lower radiographic progression and reduced functional deficit. Disclosure  M.H. Buch: Consultancies; MHB reports serving as a consultant for AbbVie; Eli Lilly; Gilead Sciences, Inc.; Sandoz; Sanofi; and Serono. Grants/research support; MHB reports grants or research support from Pfizer, Roche, and UCB. D. Walker: Grants/research support; DW has received funding from Bristol-Myers Squibb; Eli Lilly; Gilead Sciences, Inc.; Novartis; and Pfizer, Inc. P.D.W. Kiely: Other; PK has attended advisory boards, been part of a speakers bureau, or received support to attend educational meetings from AbbVie, Gilead, Lilly, Novartis, and Sanofi. C.J. Edwards: Consultancies; CJE has provided consultancy for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Member of speakers’ bureau; CJE has served on speaker's bureaus for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Grants/research support; CJE reports grants from AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. J. Barry: Corporate appointments; JB is an employee of Gilead Sciences Ltd. G. McCaughey: Corporate appointments; GMcC is an employee of Gilead Sciences Ltd. L. Akroyd: Corporate appointments; LA is an employee of Gilead Sciences Ltd. I. Tiamiyu: Corporate appointments; IT is an employee of Gilead Sciences, Inc. L. Ye: Corporate appointments; LY is an employee of Gilead Sciences, Inc. K. Chen: Corporate appointments; KC is an employee of Gilead Sciences, Inc. P.C. Taylor: Consultancies; PCT has served as a consultant to AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Pfizer, BMS, Roche, Sanofi, Nordic Pharma, Fresenius, and UCB. Grants/research support; PCT reports research grants from Gilead Sciences, Inc.; Galapagos, and Celgene.

scholarly journals Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)

2018 ◽  
Vol 77 (5) ◽  
pp. 690-698 ◽  
Author(s):  
Peter Nash ◽  
Kamal Ohson ◽  
Jessica Walsh ◽  
Nikolay Delev ◽  
Dianne Nguyen ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Safety Profile ◽  
Controlled Trial ◽  
Health Assessment ◽  
Tender Joint ◽  
American College Of Rheumatology ◽  
Das 28 ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveEvaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.MethodsPatients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52.ResultsAmong 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).ConclusionsIn biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.Trial registration numberNCT01925768; Results.

scholarly journals Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

2009 ◽  
Vol 69 (2) ◽  
pp. 413-416 ◽  
Author(s):  
J H Coombs ◽  
B J Bloom ◽  
F C Breedveld ◽  
M P Fletcher ◽  
D Gruben ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Status ◽  
Short Form ◽  
Controlled Trial ◽  
Health Assessment ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Double Blind ◽  
Sf 36 ◽  
Factor Α

Objectives:To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor α inhibitor.Methods:Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.Results:At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (⩾0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components.Conclusions:CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

scholarly journals IMPACT OF DIFFERENT LEVELS OF DISEASE ACTIVITY IN PAINFUL PROFILE AND QUALITY OF LIFE IN PEOPLE WITH RHEUMATOID ARTHRITIS

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Selena Márcia Dubois Mendes ◽  
Bárbara Liliane Lôbo Queiroz ◽  
Larissa Vieira Santana ◽  
Abrahão Fontes Baptista ◽  
Mittermayer Barreto Santiago ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Pain Perception ◽  
Short Form ◽  
Care Service ◽  
Cross Sectional ◽  
Sf 36 ◽  
Different Levels

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disease with impact on increasing the morbidity and mortality rates. Different levels of disease activity (LDA) have been established, however, its impact on pain and quality of life have yet to be been evidenced. The aim of this study was to evaluate the relationship of different levels of disease activity on the painful profile and quality of life (QOL) of patients diagnosed with RA. This was a cross-sectional study, conducted in RA patients attending an Educational Outpatient Care Service in Salvador, Bahia, Brazil. The LDA was defined according to values of Erythrocyte Sedimentation Rate (ESR), Visual Analog Scale (VAS), and number of swollen and sore joints, according to the Disease Activity Score in 28 joints (DAS28). Types of pain were assessed using the Douleur Neuropathique en 4 questions (DN4). To evaluate QOL, the Short Form (36) Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) were applied. The association between LDA, QOL and painful profile was verified using One Way-ANOVA and Bonferroni correction post-test. A high LAD was observed in 67.7% of the 96 patients  evaluated in this study. Pain sensation was reported by 94.8 % of participants with 40.6 % reporting it as nociceptive and 80.2% as intense. It was also observed that the higher LAD found the higher was the pain intensity reported (p=0.001) and lower QOL scores (p<0.001). Although the LDA did not correlate with the type of pain (p=0.611), it was correlated with the total score obtained in the QOL from the HAQ (p=0.001). The greatest impact on QOL evaluated through the SF-36 were physical (p<0.001) and functional capacity (p<0.001). In conclusion, RA patients who had high LDA reported more severe pain perception and obtained the lowest scores in the assessment of quality of life.

scholarly journals Correlation Between Carotid Intima-Media Thickness and the Activity of Rheumatoid Arthritis: A 1-Year Cross-Sectional Study

2018 ◽  
Vol 30 (3) ◽  
pp. 34-41
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Media Thickness ◽  
Das 28 ◽  
Significant Difference ◽  
The Mean

Background and objectives: Among several noninvasive techniques available, a high-resolution B-mode ultrasonography is the widely used technique to measure carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients with elevated cardiovascular risk. The present study was undertaken to explore the clinical relationship between CIMT and disease activity in patients with RA. Methods: This study involved 50 adult patients with RA. Demographic, physical, systemic, and clinical data and history of the patients were recorded. Investigations, such as erythrocyte sedimentation rate, highly sensitive C-reactive protein, renal and liver function tests, RA factor, and anticyclic citrullinated peptide antibody tests were performed. CIMT was assessed using highresolution B-mode ultrasonography and the disease severity was assessed based on disease activity score (DAS) 28. Results: The mean age of the RA patients was 49.88 ± 12.12 years with male predilection. The mean duration, mean European League Against Rheumatism (EULAR) criteria score, and mean DAS 28 score in RA patients were 3.62 ± 3.25 years, 8.10 ± 1.58, and 4.91 ± 1.11, respectively. The mean CIMT observed in RA patients was 0.94 ± 0.31 cm. Significant difference was observed in the mean CIMT values of different variables, including duration of joint pain (P = 0.007), tender joint count (P < 0.001), swollen joint count (P < 0.001), EULAR criteria score (P < 0.001), and DAS 28 score (P < 0.001). Also, CIMT correlated positively with tender joint count (r = 0.711; P < 0.001), swollen joint count (r = 0.673; P < 0.001), EULAR criteria score (r = 0.611; P < 0.001), and DAS 28 score (r = 0.729; P < 0.001). Conclusion: A strong correlation was observed between CIMT and disease activity in patients with RA. Hence, CIMT can be a useful surrogate marker for detecting atherosclerosis in patients with RA.

scholarly journals AB0064 EVALUATION OF QUALITY OF LIFE IN RHEUMATOID ARTHRITIS USING SF-36 AND HAQ SCALES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1063.1-1063
Author(s):  
M. Brahem ◽  
M. Hassayoun ◽  
H. Hachfi ◽  
R. Sarraj ◽  
M. Ardhaoui ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Short Form ◽  
Bodily Pain ◽  
Global Score ◽  
Sf 36 ◽  
The Mean ◽  
The Impact

Background:The assessment of health-related quality-of-life (HRQoL) in rheumatoid arthritis (RA) is becoming a common tool in clinical practice. The medical outcomes survey short form 36 (SF- 36) is one of the most widely used tools for measuring HRQoL in RA as well as the HAQ scale.Objectives:The aim of our study is to evaluate the impact of the RA in the quality of life (QoL) of our patients using the SF-36 and the HAQ questionnaires.Methods:This is a cross-sectional study during a period of the year 2020, including 70 patients followed in the department of Rheumatology in Mahdia, Tunisia. All patients were diagnosed with RA based in ACR 1987/EULAR 2010. We evaluated for each patient, the mean global scale and the eight domains of SF-36 (physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), a social functioning (SF), role emotional (RE) and mental health (MH)), scored from 0 (worst) to 100 (best).Results:Our study included 70 patients (59 females/11males) with an age ranged from 21 to 76 years. The mean age was 54 ± 12 years. The mean duration of the disease was 11 ± 10 years [1-40]. The mean number of tender joints was 9.7 ±9.4 and swollen joints were 4.2 ±6.1. The mean disease activity score (DAS28) was 4.6 ±1.9 [1.2-8.4]. The mean HAQ score was 1.5±1.3, 47.1% of patients had specific joint deformations, 82.9% had radiologic involvement and 31.4% had osteoporosis. The biologic analysis showed that the mean ESR was 46.7 ± 30.5 and the CRP was 15.8 ±23.3. Rheumatoid factors were positive in 42.9% of cases, the ACPA were positive in 50% of cases. 84.3% of RA patients were treated by methotrexate, 4.3% were treated by salazopyrin and 11.4% were treated by biologic treatments.The SF-36 global score was 50.4 ± 26.3 [15.3-92.8]. 46 patients (65.7% of cases) had impaired QoL (SF-36<66.7). The means of different domains (PF, RP, BP, GH, VT, SF, RE, MH) were respectively 51; 41.4; 51.4; 50; 51.2; 57.7; 41.9; 59.2. The most severely impacted domains were the RP and RE.Our study showed a significant correlation between the SF-36 global score and the number of tender joints (p=0.002), the DAS28 (p=0.017) and the HAQ(p=0.000).Conclusion:Our study showed that 65.7% of RA patients presented impaired QoL (SF-36<66.7), which is associated with high disease activity. So it’s important to jugulate the disease, in order to ameliorate the quality of life of our patients.References:[1]Matcham, F., Scott, IC, Rayner, L., Hotopf, M., Kingsley, GH, Norton, S.,… Steer, S. (2014). L’impact de la polyarthrite rhumatoïde sur la qualité de vie évalué à l’aide du SF-36: une revue systématique et une méta-analyse. Séminaires sur l’arthrite et les rhumatismes, 44 (2), 123-130. doi: 10.1016 / j.semarthrit.2014.05.001.Disclosure of Interests:None declared

scholarly journals FRI0567 CONSTRUCT VALIDATION OF PROMIS SHORT FORM AND PROFILE-29 T-SCORES WITH SF-36 IN RHEUMATOID ARTHRITIS PATIENTS TREATED FOR 1 YEAR: RESULTS FROM A REAL‑WORLD EVIDENCE-BASED STUDY IN THE UNITED STATES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 886.2-886
Author(s):  
C. Bingham ◽  
S. Kafka ◽  
S. Black ◽  
S. Xu ◽  
W. Langholff ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Sleep Disturbance ◽  
Pain Intensity ◽  
Real World ◽  
Short Form ◽  
Research Support ◽  
Sf 36 ◽  
Component Scores

Background:Use of patient-reported outcomes (PROs) to assess health-related quality of life in clinical practice, research studies, and clinical trials in rheumatoid arthritis (RA) remains an ongoing area of research. SF-36 is commonly used in RA trials but is not feasible for routine use in clinical practice settings. ThePatientReportedOutcomesMeasurementInformationSystem (PROMIS) may address this gap but has not been widely assessed in RA patients starting therapy in a real-world comparative effectiveness study, nor examined in that setting in relation to the SF36 and Clinical Disease Activity Index (CDAI).Objectives:To assess validity of PROMIS based on Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in Rheumatoid Arthritis (AWARE), an ongoing Phase 4 study providing real-world assessment of IV tumor necrosis factor inhibitor (TNFi) medications in RA patients.Methods:AWARE is a prospective, non-interventional, 3-year study conducted at 88 US sites. RA patients were enrolled when initiating TNFi treatment. Treatment decisions were made by treating rheumatologists. We report baseline PROMIS-29 (7 domains and pain intensity), PROMIS Pain Interference (PI) Short Form (SF) 6b (PI6b) and PROMIS Fatigue (F) Short Form 7a (F7a), domain T-Scores, and SF-36 subdomain and Component Scores (CS) in AWARE patients. Here we report baseline data obtained from the final 1-year AWARE dataset. Correlations between PROMIS measures and comparable SF-36 component scores were calculated using Pearson correlations. Data is shown as mean ± standard deviation (SD).Results:At baseline, mean CDAI of all patients (n=1262) was 32.3±15.6, with 70.4% in high disease activity (HDA, CDAI>22), 22.8% in moderate disease activity (MDA, CDAI: >10 and ≤22), 6.1% in low disease activity (LDA, CDAI: >2.8 and ≤10), and 0.7% in remission (CDAI ≤2.8). Mean PROMIS scores were >0.5 SD worse than population means for Physical Function (PF, 38.1±6.84), PI (63.4±7.68), F (58.8±9.95), Sleep Disturbance (55.1±8.68); and Ability to Participate in Social Roles/Activities (PSRA, 43.4±8.58). Baseline Depression and Anxiety were within 0.5 SD of population T-scores. PI6b, F7a, and P29 domain T-scores correlated with the comparable SF-36 subdomain and component scores (r’s >0.58), except sleep for which no comparable SF-36 element was applicable. Examples include: P6b (r=-0.80) and P29-PI (0.81) with SF-36 Bodily Pain; F7a (-0.77) and P29-F (-0.77) with SF-36 Vitality; P29-PF with SF-36 PF (0.77), Role-Physical (0.69), and Physical CS (0.73); P29 Anxiety with SF-36 Mental Health (-0.72), Role-Emotional (-0.56), Mental CS (-0.70); and P29-PRSA with SF-36-Social Functioning (0.71). Mean PROMIS-29 T-scores (except Anxiety and Sleep Disturbance) among patients with HDA were significantly different from patients with MDA, LDA or remission (p < 0.001 for all). Further, mean PROMIS T-scores of PF, F, PSRA, PI, Pain Intensity, PI6b and P7a among patients with MDA were significantly different from patients with more or less active RA (by CDAI category).Conclusion:Analysis of baseline results from a large cohort of RA patients indicates high correlations between individual P29 domain T-scores and SF-36 component scores, as well as categorical CDAI, providing strong evidence of PROMIS construct validity in a real-world population of RA patients.Disclosure of Interests:Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB

scholarly journals Improvement of Inflammation and Pain After Three Months’ Exclusion Diet in Rheumatoid Arthritis Patients

2021 ◽  
Author(s):  
Guagnano Maria Teresa ◽  
D’Angelo Chiara ◽  
Caniglia Daniela ◽  
Celletti Eleonora ◽  
Emanuela Sabatini ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Short Form ◽  
Health Assessment ◽  
Normal Diet ◽  
Systemic Autoimmune Disease ◽  
Physical And Mental Health ◽  
Balanced Diet ◽  
Number Of Patients ◽  
Sf 36 ◽  
Exclusion Diet

Abstract Introduction: Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease affecting the synovial joints and causing severe disability. Environmental and lifestyle factors, including diet, have been proposed to play a role in the onset and severity of RA. Dietary manipulation may help, to manage the symptoms of RA, by lowering inflammation, and potentially decreasing pain.Methods: In 40 patients with long standing RA, with stable symptoms, and treated with conventional (c-) and biological (b-) Disease modifying anti-rheumatic drugs (DMARDs), the effect of 3-months’ diet avoiding meat, gluten, and lactose (privative diet) was evaluated in comparison with a control balanced diet including those foods. Patients choosing the exclusion diet were followed in parallel to an equal number of patients on their normal diet, and RA was clinically assessed at Time 0 (T0), through the Visual Analogue Scale (VAS), for pain, and the Disease Activity Score of 28 joints (DAS 28) for RA activity. Patients were also administered the Short Form Health survey (SF-36) and the Health Assessment Questionnaire (HAQ). At T0 a blood sample was collected for laboratory tests, and anthropometric measurements were recorded. These evaluations were repeated at the end of the 3 months’dietary regimens.Results: A significant decrease in VAS and the improvement of the overall state of physical and mental health, assessed through SF-36, was observed in patients following the avoidance diet. Both dietary regimens resulted in the improvement of quality of life compared to baseline values, however the change was significant only for the exclusion diet. With either diet, patients showed significant decreases of body weight and body mass index (BMI), with a reduction of waist and hips circumferences, lower basal glucose and circulating leptin levels. Exclusion diet was also able to significantly reduce systolic (SYS) (p=0.002) and diastolic (DIA) (p=0.027) arterial pressure. The number of circulating leukocytes and neutrophils, and the level of hs-C-Reactive Protein (CRP) were also significantly decreased after 3 months of the meat-, lactose, and gluten-free diet.Conclusions: Our results suggest that an exclusion diet can result in a better control of inflammation and pain in RA patients under stable optimized drug treatment.

Sign in / Sign up

Export Citation Format

Share Document