scholarly journals Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Mohammed Hammoudeh ◽  
Adel Al Awadhi ◽  
Eman Haji Hasan ◽  
Maassoumeh Akhlaghi ◽  
Arman Ahmadzadeh ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Middle Eastern ◽  
Health Assessment ◽  
Open Label ◽  
Meaningful Improvement ◽  
End Points ◽  
Safety And Efficacy ◽  
Reactive Protein ◽  
Open Label Phase

This open-label study investigated the safety and efficacy of tocilizumab in Middle Eastern patients with rheumatoid arthritis (RA). Patients whose Disease Activity Score based on 28 joints (DAS28) was >3.2 received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks. Patients receiving aTNF ± nonbiologic disease-modifying antirheumatic drug(s) (DMARD(s)) switched to tocilizumab; patients receiving nonbiologic DMARD monotherapy added tocilizumab. Primary end points were adverse events (AEs), serious AEs (SAEs), and laboratory parameters; secondary end points were DAS28, Health Assessment Questionnaire-Disability Index, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Eighty-eight of 95 patients completed 24 weeks. Overall, 125 AEs were reported in 43 (45%) patients; the most common were increased hepatic enzymes (16%) and cholesterol (11%). Eight patients experienced SAEs. Significant changes from baseline to week 24 occurred for hemoglobin, neutrophils, platelets, total cholesterol, and liver enzymes (P<0.05). DAS28, CRP, and ESR decreased significantly from baseline at each visit (P<0.0001). At week 24, the proportions of patients reporting DAS28 clinically meaningful improvement (decrease ≥1.2), low disease activity (DAS28 ≥2.6 to ≤3.2), and remission (DAS28 <2.6) were 92%, 23%, and 64%, respectively. Safety and efficacy of tocilizumab were consistent with values reported in Western patients.

scholarly journals Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study

2019 ◽  
Vol 78 (8) ◽  
pp. 1033-1040 ◽  
Author(s):  
Sophie Glatt ◽  
Peter C Taylor ◽  
Iain B McInnes ◽  
Georg Schett ◽  
Robert Landewé ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Certolizumab Pegol ◽  
Inadequate Response ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Reactive Protein ◽  
Dual Inhibition

ObjectiveEvaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F with bimekizumab, a monoclonal IgG1 antibody, in addition to certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) and inadequate response (IR) to certolizumab pegol.MethodsDuring this phase 2a, double-blind, proof-of-concept (PoC) study (NCT02430909), patients with moderate-to-severe RA received open-label CZP 400 mg at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients with IR at Week 8 (Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP))>3.2) were randomised 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety variables were change in DAS28(CRP) between Weeks 8 and 20 and incidence of treatment-emergent adverse events (TEAEs).ResultsOf 159 patients enrolled, 79 had IR at Week 8 and were randomised to CZP plus bimekizumab (n=52) or CZP plus placebo (n=27). At Week 20, there was a greater reduction in DAS28(CRP) in the CZP-IR plus bimekizumab group compared with the CZP-IR plus placebo group (99.4% posterior probability). The most frequent TEAEs were infections and infestations (CZP plus bimekizumab, 50.0% (26/52); CZP plus placebo, 22.2% (6/27)).ConclusionsPoC was confirmed based on the rapid decrease in disease activity achieved with 12 weeks of CZP plus bimekizumab. No unexpected or new safety signals were identified when neutralising IL-17A and IL-17F in patients with RA concomitantly treated with CZP, but the rate of TEAEs was higher with dual inhibition.

KEYNOTE-204: Randomized, open-label, phase III study of pembrolizumab (pembro) versus brentuximab vedotin (BV) in relapsed or refractory classic Hodgkin lymphoma (R/R cHL).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8005-8005 ◽  
Author(s):  
John Kuruvilla ◽  
Radhakrishnan Ramchandren ◽  
Armando Santoro ◽  
Ewa Paszkiewicz-Kozik ◽  
Robin Gasiorowski ◽  
...  
Keyword(s):  
Autologous Stem Cell Transplant ◽  
Brentuximab Vedotin ◽  
Phase Iii ◽  
Cell Transplant ◽  
Imaging Data ◽  
Open Label ◽  
Meaningful Improvement ◽  
End Points ◽  
Open Label Phase ◽  
Phase Iii Study

8005 Background: PD-1 blockade via pembro monotherapy showed antitumor activity in R/R cHL. KEYNOTE-204 (NCT02684292) was a randomized, international, open-label, phase III study of pembro vs BV in R/R cHL. Methods: Patients (pts) were aged ≥18 y, were post−autologous stem cell transplant (auto-SCT) or ineligible for auto-SCT, and had measurable disease and ECOG PS 0 or 1. BV-naive and BV-exposed pts were eligible. Pts were randomized 1:1 to pembro 200 mg IV Q3W or BV 1.8 mg/kg IV Q3W and stratified by prior auto-SCT (yes vs no) and status after 1L therapy (primary refractory vs relapsed <12 mo vs relapsed ≥12 mo after end of 1L therapy). Primary end points: PFS by blinded independent central review (BICR) per International Working Group (IWG) criteria including clinical and imaging data after auto-SCT or allogeneic SCT (allo-SCT) and OS. Key secondary end points: PFS excluding clinical and imaging data after auto-SCT or allo-SCT (PFS-secondary), and ORR by BICR per IWG, PFS by investigator review per IWG, and safety. Exploratory end point: DOR by BICR per IWG. Results: 304 pts were randomized and 300 were treated (148, pembro; 152, BV); 256 discontinued. Median (range) follow-up: 24.7 (0.6-42.3) mo. 15 pts were BV exposed. Median (range) time on treatment was 305.0 (1-814) and 146.5 (1-794) days with pembro and BV, respectively. Statistically significant improvement was observed with pembro vs BV for primary PFS analysis (HR 0.65 [95% CI 0.48-0.88; P =0.00271]; median 13.2 vs 8.3 mo); 12-mo PFS rates were 53.9% vs 35.6%, respectively. Benefit was observed in all subgroups tested, including pts with no auto-SCT (HR=0.61), primary refractory disease (HR=0.52), prior BV (HR=0.34) and BV naive (HR=0.67). Significant improvement in PFS-secondary was observed with pembro vs BV (HR 0.62 [95% CI 0.46-0.85]; median 12.6 vs 8.2 mo). Per investigator assessment, PFS was longer with pembro vs BV (HR 0.49 [95% CI 0.36-0.67]; median 19.2 vs 8.2 mo). ORR was 65.6% for pembro and 54.2% for BV; CR rates were 24.5% and 24.2%, respectively. Median (range) DOR was 20.7 mo (0.0+ to 33.2+) for pembro and 13.8 mo (0.0+ to 33.9+) for BV. Grade 3-5 TRAEs: 19.6% of pts with pembro and 25.0% with BV. One death due to TRAE occurred with pembro (pneumonia). Conclusions: In pts with R/R cHL, pembro was superior to BV and demonstrated statistically significant and clinically meaningful improvement in PFS across all subgroups, with safety consistent with previous reports. Pembro monotherapy should be standard of care for this pt population with R/R/cHL. Clinical trial information: NCT02684292 .

Differences in Predictive Factors for Sustained Clinical Remission with Abatacept Between Younger and Elderly Patients with Biologic-naive Rheumatoid Arthritis: Results from the ABROAD Study

2016 ◽  
Vol 43 (11) ◽  
pp. 1974-1983 ◽  
Author(s):  
Masahiro Sekiguchi ◽  
Takao Fujii ◽  
Kiyoshi Matsui ◽  
Kosaku Murakami ◽  
Satoshi Morita ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Elderly Patients ◽  
Disease Activity ◽  
Predictive Factors ◽  
Clinical Remission ◽  
Health Assessment ◽  
The Elderly ◽  
Joint Disease ◽  
Younger Patients ◽  
Reactive Protein

Objective.To differentiate predictive factors for sustained clinical remission between elderly and younger patients with rheumatoid arthritis (RA) receiving abatacept (ABA) as an initial biological disease-modifying antirheumatic drug.Methods.The study involved 277 biologic-naive patients with RA with high or moderate disease activity, who were treated with intravenous ABA and evaluated for 48 weeks in 43 Japanese hospitals and rheumatology clinics (the ABatacept Research Outcomes as a First-line Biological Agent in the Real WorlD study: UMIN000004651). Predictive factors associated with sustained clinical remission defined by the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) during the 24–48–week or 36–48–week periods were determined in elderly (≥ 65 yrs, n = 148) and younger patient groups (< 65 yrs, n = 129) using logistic regression analysis.Results.Clinical remission was achieved at 24 and 48 weeks in 35.1% and 36.5% of patients in the elderly group and 34.9% and 43.4% in the younger group, respectively. In elderly patients, anticitrullinated protein antibody (ACPA) positivity and a lower DAS28-CRP score were significantly associated with sustained clinical remission; however, a lower Health Assessment Questionnaire-Disability Index (HAQ-DI) score was not related to sustained clinical remission. In younger patients, lower DAS28-CRP and HAQ-DI scores were predictive factors for sustained clinical remission, whereas ACPA positivity was not a useful predictive factor for sustained clinical remission.Conclusion.Although the effectiveness of ABA in biologic-naive patients with RA was equally recognized in elderly and younger patients, the baseline clinical characteristics associated with sustained clinical remission were substantially different.

scholarly journals Background Glucocorticoid Therapy Has No Impact on Efficacy and Safety of Abatacept or Adalimumab in Patients with Rheumatoid Arthritis

2020 ◽  
Vol 9 (6) ◽  
pp. 2017
Author(s):  
Yannick Degboé ◽  
Michael Schiff ◽  
Michael Weinblatt ◽  
Roy Fleischmann ◽  
Harris A. Ahmad ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Similar Proportion ◽  
Efficacy And Safety ◽  
Reactive Protein ◽  
Radiographic Outcomes ◽  
Score Improvement ◽  
Additional Value ◽  
The Impact

To date, the impact of background glucocorticoids (GC) on the efficacy and safety of abatacept or adalimumab in patients with active rheumatoid arthritis (RA) is not clearly established. This post hoc analysis of (AMPLE) trial (NCT00929864) compared efficacy and safety outcomes over 2 years in patients treated with abatacept or adalimumab plus background methotrexate (MTX), who continued GC (≤10 mg/day) versus those who were not receiving GC (no-GC). Of 646 randomized patients, 317 received abatacept + MTX (161 GC, 156 no-GC) and 326 received adalimumab + MTX (162 GC, 164 no-GC). At Year 2, the adjusted mean changes from baseline in Disease Activity Score (DAS28 C-reactive protein (CRP)) and Health Assessment Questionnaire-Disability Index (HAQ-DI) were not significantly different in the GC versus no-GC subgroups receiving abatacept or adalimumab. A similar proportion of patients achieved remission, HAQ-DI score improvement ≥0.3 and radiographic progression rates. No clinically meaningful safety differences were observed between GC versus no-GC subgroups either with abatacept or adalimumab. In patients with active RA of similar baseline disease activity treated with abatacept or adalimumab plus background MTX, there was no additional value of background GC on clinical, functional or radiographic outcomes over two years.

scholarly journals Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000840 ◽  
Author(s):  
Paul Emery ◽  
Gerd R Burmester ◽  
Vivian P Bykerk ◽  
Bernard G Combe ◽  
Daniel E Furst ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Treatment Withdrawal ◽  
Open Label ◽  
Double Blind ◽  
Reactive Protein ◽  
Complete Treatment ◽  
Therapy Withdrawal ◽  
Questionnaire Disability

ObjectivesTo complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing Very Early Rheumatoid arthritis Treatment study (NCT01142726).MethodsPatients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus methotrexate, or abatacept or methotrexate monotherapy. At month 12, patients with Disease Activity Score (DAS)28 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawn and were observed for ≤12 months or until flare. After ≥3 months’ withdrawal, patients with protocol-defined RA flare received open-label abatacept plus methotrexate for 6 months (re-treatment).Results Proportion of patients in DAS28-CRP–defined remission remained numerically higher in original abatacept plus methotrexate and abatacept arms versus methotrexate arm up to day 253 of withdrawal. At the end of the withdrawal period, few patients remained in remission across all arms: 9/73 (12.3%), 7/50 (14.0%) and 6/53 (11.3%), respectively. For patients entering re-treatment, after 6 months’ re-treatment, 95/124 (76.6%) and 78/124 (62.9%) patients achieved DAS28-CRP <3.2 and <2.6, respectively; mean changes in DAS28-CRP and Health Assessment Questionnaire–Disability Index scores from re-treatment baseline were –2.87 and 0.76, respectively. Re-treatment was well tolerated; exposure-adjusted infection rates per 100 patient-years were lower with abatacept plus methotrexate during withdrawal (7.2) and re-treatment (17.2) versus initial treatment periods of months 0–6 (116.6) and 6–12 (64.6).ConclusionsMost patients flared within 6 months of therapy withdrawal and few sustained major responses for 1 year. Re-treatment with abatacept plus methotrexate was effective and well tolerated in this controlled setting.

scholarly journals Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001017 ◽  
Author(s):  
Gerd R Burmester ◽  
Vibeke Strand ◽  
Andrea Rubbert-Roth ◽  
Howard Amital ◽  
Tatiana Raskina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Normative Values ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Patient Reported ◽  
Open Label Extension

ObjectiveEvaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).MethodsDuring the 48-week OLE, patients received sarilumab 200 mg subcutaneously once every 2 weeks. Safety (March 2017 cut-off) and efficacy, including patient-reported outcomes, were evaluated.ResultsIn the double-blind phase, patients receiving sarilumab or adalimumab monotherapy showed meaningful improvements in disease activity; sarilumab was superior to adalimumab for improving signs, symptoms and physical function. Overall, 320/369 patients completing the 24-week double-blind phase entered OLE (155 switched from adalimumab; 165 continued sarilumab). Sarilumab safety profile was consistent with previous reports. Treatment-emergent adverse events were similar between groups; no unexpected safety signals emerged in the first 10 weeks postswitch. Among switch patients, improvement in disease activity was evident at OLE week 12: 47.1%/34.8% had changes ≥1.2 in Disease Activity Score (28 joints) (DAS28)-erythrocyte sedimentation rate/DAS28-C-reactive protein. In switch patients achieving low disease activity (LDA: Clinical Disease Activity Index (CDAI) ≤10; Simplified Disease Activity Index (SDAI) ≤11) by OLE week 24, 70.7%/69.5% sustained CDAI/SDAI LDA at both OLE weeks 36 and 48. Proportions of switch patients achieving CDAI ≤2.8 and SDAI ≤3.3 by OLE week 24 increased through OLE week 48. Improvements postswitch approached continuation-group values, including scores ≥normative values.ConclusionsDuring this OLE, there were no unexpected safety issues in patients switching from adalimumab to sarilumab monotherapy, and disease activity improved in many patients. Patients continuing sarilumab reported safety consistent with prolonged use and had sustained benefit.

scholarly journals Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift)

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001673
Author(s):  
Stanley B Cohen ◽  
Janet Pope ◽  
Boulos Haraoui ◽  
Eduardo Mysler ◽  
Annette Diehl ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Safety Profile ◽  
Activity Index ◽  
Inadequate Response ◽  
Modified Release ◽  
Open Label ◽  
Once Daily ◽  
Patient Reported ◽  
Open Label Phase

ObjectivesTo report the efficacy, safety and patient-reported outcome measures (PROs) of tofacitinib modified-release 11 mg once daily plus methotrexate in patients with rheumatoid arthritis (RA) from the open-label phase of Oral Rheumatoid Arthritis Trial (ORAL) Shift.MethodsORAL Shift was a global, 48-week, phase 3b/4 withdrawal study in patients with moderate to severe RA and an inadequate response to methotrexate. Patients received open-label tofacitinib modified-release 11 mg once daily plus methotrexate; those who achieved low disease activity (LDA; Clinical Disease Activity Index (CDAI)≤10) at week 24 were randomised to receive blinded tofacitinib 11 mg once daily plus placebo (ie, blinded methotrexate withdrawal) or continue with blinded tofacitinib 11 mg once daily plus methotrexate for another 24 weeks. Efficacy, PROs and safety from the open-label phase are reported descriptively.ResultsFollowing screening, 694 patients were enrolled and received tofacitinib plus methotrexate in the open-label phase. At week 24, 527 (84.5%) patients achieved CDAI-defined LDA. Improvements from baseline to weeks 12 and 24 were generally observed for all efficacy outcomes (including measures of disease activity, and response, LDA and remission rates) and PROs. Adverse events (AEs), serious AEs and discontinuations due to AEs were reported by 362 (52.2%), 20 (2.9%) and 41 (5.9%) patients, respectively. No deaths were reported.ConclusionsTofacitinib modified-release 11 mg once daily plus methotrexate conferred improvements in disease activity measures, functional outcomes and PROs, with most (84.5%) patients achieving CDAI-defined LDA after 24 weeks of open-label treatment; the safety profile was generally consistent with the historic safety profile of tofacitinib.Funded by Pfizer Inc; NCT02831855.

scholarly journals Clinical aspects of the use of etanercept in treatment of rheumatoid arthritis.

2018 ◽  
Vol 95 (11) ◽  
pp. 1007-1012
Author(s):  
Pavel A. Shesternya ◽  
M. M. Petrova ◽  
O. D. Gritsenko
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Stable Condition ◽  
Treatment Interruption ◽  
Treat To Target ◽  
Clinical Aspects ◽  
Reactive Protein ◽  
Effective Combination ◽  
Number Of Patients

Background. Maintaining of a favourable response of tumour necrosis factor inhibitors is one of the most challenging to rheumatologist. Only limited data have been published addressing this field. The aim of our study was investigate efficacy of etanercept (ETN) and evaluate maintaining response after ETN discontinuation in patients who have achieved remission or low disease activity (REM/LDA) of rheumatoid arthritis (RA). Methods. Patients with high disease activity (n = 29) received ETN 50 mg injection and methotrexate 10-20 mg once weekly were included in analysis. Frequency of REM/LDA scoring by DAS 28-joint counts and C-reactive protein level (DAS28-CRP), changes from baseline in DAS28-CRP, Health Assessment Questionnaire (HAQ), global assessment of disease activity by patient and provider (PtGA and PrGA) were evaluated. We assessed persistent of achieved REM/LDA after the ETN discontinued. Results. We saw fast decreasing of active flare already after first month: HAQ (1.4 ± 0.6 vs 2.0 ± 0.6, p = 0.048), PtGA (49.5 ± 17.9 vs 75.6 ± 14.9, p = 0.016) and PrGA (46.6 ± 14.7 vs 77.0 ± 12.3, p = 0.014). DAS28-CRP changes from baseline become significant after second month (3.9 ± 1.1 vs 6.2 ± 0.6, р = 0.005). After 6 months 82.6% patients had DAS28-CRP < 3.2 and 41.4% patients had HAQ < 0.5. Maintenance of REM/LDA lasted 3 month after ETN discontinuation. Conclusion. ETN+MTX is very effective combination in treat to target strategy of RA treatment. In patients who have achieved REM/LDA maintained stable condition during three months after ETN withdrawn. It might be consider in a number of patients in case of accidental or necessary treatment interruption.

scholarly journals Longterm Safety and Efficacy of Tocilizumab in Patients with Rheumatoid Arthritis: A Cumulative Analysis of Up to 4.6 Years of Exposure

2013 ◽  
Vol 40 (6) ◽  
pp. 768-780 ◽  
Author(s):  
Mark C. Genovese ◽  
Andrea Rubbert-Roth ◽  
Josef S. Smolen ◽  
Joel Kremer ◽  
Majed Khraishi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Total Duration ◽  
Tender Joint Count ◽  
Open Label ◽  
Safety And Efficacy ◽  
Disease Remission ◽  
Core Set ◽  
Das28 Remission ◽  
Safety Signals

Objective.To assess the longterm safety and efficacy of tocilizumab (TCZ) in patients with moderate to severe rheumatoid arthritis (RA).Methods.Patient data were from 5 randomized controlled TCZ trials (n = 4211), their open-label extension phases (n = 3512), and a drug interaction study (n = 23). All randomly assigned patients, regardless of previous RA treatment, were analyzed. Measures of safety included number of adverse events (AE), serious AE (SAE), AE leading to treatment discontinuation, laboratory tests, and deaths. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 responses, tender joint count (TJC), swollen joint count (SJC), ACR core set components, and low disease activity (LDA) or Disease Activity Score in 28 joints (DAS28) remission. ACR/European League Against Rheumatism (EULAR) disease remission was a posthoc exploratory analysis.Results.Total duration of observation was 12,293 patient-years (PY). No new safety signals were identified; infections were the most common AE and SAE. The rate of serious infections was 4.5/100 PY. Improvements from baseline in clinical efficacy, measured as ACR20/50/70 responses, TJC, SJC, ACR core set components, and LDA and DAS28 remission, were generally sustained through at least 216 weeks of followup. ACR/EULAR disease remission was attained by 16.5% (Boolean) and 22.7% (index) of patients at Week 216.Conclusion.TCZ has to date been studied for up to 4.6 years (240 weeks) of treatment in patients with RA. Our analysis reveals a longer-term safety profile consistent with previous observations, no new safety signals, and durable efficacy of TCZ in a large clinical trial program.

scholarly journals Neuropathic pain in a sample of Egyptian patients with rheumatoid arthritis

2020 ◽  
Vol 47 (1) ◽  
Author(s):  
Abdullah Radwan ◽  
Ahmed Borai
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Neuropathic Pain ◽  
Disease Activity ◽  
Functional Disability ◽  
Disease Duration ◽  
Univariate Analysis ◽  
Health Assessment ◽  
Reactive Protein ◽  
Important Symptom

Abstract Background Rheumatoid arthritis (RA) is an autoimmune disease characterized by polyarthritis that may cause irreversible joint disability. Pain is the most important symptom in RA patients that requires more attention and careful evaluation. Despite the improvement in medications used to control inflammation in RA patients, a relevant number of them still experience neuropathic pain even with disease remission. This study was conducted to estimate the frequency of neuropathic pain (NP) in RA patients and to assess its relationship with disease activity, functional status, and overweight. Results NP was detected in 12.5% (14 patients) of RA patients. Highly significant differences were found between RA patients with NP and those without NP as regards disease duration, visual analog scale (VAS) of pain, disease activity score 28 (DAS28-ESR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), body mass index (BMI), health assessment questionnaire (HAQ) score, and Douleur Neuropathique in 4 (DN4) questionnaire for NP assessment (p < 0.001). The correlation between the DN4 questionnaire and the parameters of disease activity in RA patients with NP was not significant. By univariate analysis, the possible risk factors for NP in RA patients were disease duration, VAS, DAS28-ESR, HAQ, and BMI; however, by multivariate analysis, no possible risk factors for NP in RA patients were detected. Conclusion Although pain in patients with RA was classified as nociceptive in nature, a relevant proportion of patients might also have NP. NP in RA patients was related to functional disability, high disease activity, and overweight.

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