scholarly journals Continuous effectiveness and safety after a hospital-wide switch to adalimumab biosimilar: an observational study in rheumatoid arthritis patients

2021 ◽  
Author(s):  
Rianne Brouwer ◽  
Peter M. ten Klooster ◽  
Joost B. Masselink ◽  
Harald E. Vonkeman
Keyword(s):  
Rheumatoid Arthritis ◽  
Side Effects ◽  
Observational Study ◽  
Disease Activity ◽  
Functional Disability ◽  
Activity Levels ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Sf 36 ◽  
Patient Reported

Abstract Objectives Only few observational studies have investigated the actual effectiveness of switching to biosimilars in daily clinical practice in unselected patients. The objective of this study was to examine the maintenance of effect and safety after a hospital-wide switch for economic reasons from adalimumab originator Humira® to biosimilar Amgevita® in real-world rheumatoid arthritis (RA) patients and patient satisfaction with the switch. Methods A single centre retrospective observational study of RA patients on the course of their disease activity (DAS28, ESR and CRP), health-related quality of life (SF-36) and functional disability (HAQ-DI) before and up to one year after the switch, supplemented with a cross-sectional survey on satisfaction and experienced side effects approximately 18 months after the switch. Treatment outcomes were analysed with linear mixed modelling and generalized estimation equations. Results On November 1st 2018, 239 rheumatology patients switched to the adalimumab biosimilar. Of 52 RA patients who met the inclusion criteria sufficient data were available. Disease activity levels, the proportion of patients in remission (DAS28 < 2.6), and SF-36 and HAQ-DI scores did not significantly change from before the switch. 38 of the 52 analysed patients returned the questionnaire. Overall, patients were satisfied with the switch. Three patients (7.9%) stopped the biosimilar due to side effects. Conclusion Switching to the adalimumab biosimilar did not result in increased disease activity or worse patient-reported outcomes over an observation period of 9 to 12 months. Also, there was no apparent evidence of increased side effects. Patients themselves were mostly satisfied with the switching experience.

scholarly journals Fibromyalgia Is Common and Adversely Affects Pain and Fatigue Perception in North Indian Patients with Rheumatoid Arthritis

2009 ◽  
Vol 36 (11) ◽  
pp. 2443-2448 ◽  
Author(s):  
VARUN DHIR ◽  
ABLE LAWRENCE ◽  
AMITA AGGARWAL ◽  
RAMNATH MISRA
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Functional Disability ◽  
Health Assessment ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
The North ◽  
Indian Patients

Objectives.Fibromyalgia (FM) has been shown to be common in patients with rheumatoid arthritis (RA), but studies on Asian patients are lacking. It remains unclear whether FM has an adverse influence on pain, fatigue, quality of life, and mood in these patients, and what its relationship is with disease activity. We studied prevalence and effects of FM in North Indian patients with RA and associations of RA with disease activity.Methods.This cross-sectional study included 200 RA patients and an equal number of controls. Presence of FM was defined using the American College of Rheumatology 1990 criteria. Pain and fatigue scores were assessed using a 10 cm visual analog scale. Quality of life and presence of depression/anxiety were determined using validated questionnaires. Disease activity and functional disability in RA patients was assessed using the Disease Activity Score 28-3 and Health Assessment Questionnaire, respectively.Results.FM was present in 15% of patients with RA compared to 2.5% of controls in the North Indian population. RA patients with FM did not differ from those without FM in terms of age, gender, current disease-modifying agents, or steroid use. RA patients with FM had higher disease activity and worse functional disability. The number of tender and swollen joints was higher in patients with FM, but correlated poorly with each other. RA patients with FM had higher pain and fatigue scores but were not different in the quality of life or mood.Conclusion.FM is more common in North Indian patients with RA compared to controls. It adversely affects the pain and fatigue felt by RA patients. Disease activity and FM influence each other.

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 P157 Patient-reported disease activity in a large sample of ulcerative colitis patients using social media-delivered questionnaires

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S216-S217
Author(s):  
M T Abreu ◽  
F Cataldi ◽  
K Van Horn ◽  
L B Herbert ◽  
M Fridman ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Online Community ◽  
Holistic Approach ◽  
Mucosal Healing ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
The Past ◽  
Patient Reported ◽  
Patients Experience

Abstract Background Medical therapy for inflammatory bowel disease (IBD) should have dual goals of improving symptoms and mucosal healing. Patient-reported outcomes (PROs) used for approval of ulcerative colitis (UC) treatments include number of bowel movements and bloody stools.[1] Recent research highlights the discordance between PROs and mucosal healing.[2] The aim of this analysis is to understand patient perspectives on UC symptoms and disease burden based on a cross-sectional survey of UC patients. We hypothesised that UC patients experience disease activity despite treatment and that current PROs fail to capture the full impact of disease activity on patients’ lives. Methods The IBD In America survey recruited patients via InflammatoryBowelDisease.net and associated social platforms in 2019. Patients self-reported an IBD diagnosis, were 18+, lived in U.S., and participated without monetary incentive. Survey questions addressed diagnosis, symptoms, QoL, treatment, demographics, etc. Survey terms were based on how patients discuss UC in the IBD online community. Remission was defined as ‘significant reduction of symptoms without an actual cure.’ Flare was defined as ‘temporary intensification of symptoms.’ Patients were categorised by disease activity based on number of flares and remission status during the past year. Results Of 487 patients diagnosed with UC, mean age was 45.6 (SD 16.0); 85% were female; 89% moderate to severe; 78% diagnosed in past 5 years; and 51% taking 5ASAs, 37% biologics/JAKs, and 23% immunomodulators. Despite treatment, 46% experienced 15+ symptom days in the past month. Fatigue/low energy was most frequent complaint (86%) followed by urgency to move bowels (80%), abdominal pain/cramps (76%), joint pain/inflammation (67%), and bloating (66%). Daily pain was experienced by 32%; even patients in remission with no flares experienced pain at least once a month (55%). Difficulty completing daily tasks was reported by 37%, and 27% felt their UC was not controlled despite efforts to manage it. Only 7% reported being in remission with no flares (past year) and no symptoms (past month). Conclusion Most UC patients experience frequent symptoms and flares while on treatment. The most common and bothersome symptoms are not taken into account in PROs nor addressed with current treatment. A more holistic approach to patient disease is needed. Reference

scholarly journals Need for Palliative Care in Patient with Rheumatoid Arthritis: A Cross-sectional Observational Study

2021 ◽  
Vol 27 ◽  
pp. 275-280
Author(s):  
Kiran Mahendru ◽  
Nishkarsh Gupta ◽  
Manish Soneja ◽  
Rajeev Kumar Malhotra ◽  
Vinod Kumar ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Palliative Care ◽  
Observational Study ◽  
Disease Activity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Short Form ◽  
Emotional Problem ◽  
Well Being ◽  
Cross Sectional

Objectives: Rheumatoid arthritis (RA) is a chronic disorder causing inflammation in the joints and achieving remission is often the primary goal of physicians. We evaluated the suffering from RA and assessed the need for palliative care services in these patients. Materials and Methods: This cross-sectional observational study was done in 100 adult RA cases who attended the outpatient department. The Disease Activity Score 28 (DAS28), Health Assessment Questionnaire Disability Index, depression, anxiety and stress score, Short Form 36 Health Survey and numeric rating scale were assessed. The relationship between DAS28 with the other parameters and scores was assessed using Spearman’s rho correlation coefficient. Results: About 90% of patients in our study were female and majority (50%) had a moderate disease activity. The DAS28 showed a positive correlation with the degree of depression (r = 0.671, P = 0.000), anxiety (r = 0.609, P = 0.000) and stress levels (r = 0.474, P = 0.000). The patients with severe disease had a poor quality of life (QoL) [physical functioning (r = –0.737, P = 0.000); role limitation (r = –0.662, P = 0.000); emotional problem (r = –0.676, P = 0.000); energy/fatigue (r = –0.638, P = 0.000); social functioning (r = –0.658, P = 0.000); emotional well-being (r = –0.605, P = 0.000); general health (r = –0.643, P = 0.000); health change (r = –0.376, P = 0.000) and numerical rating scale score for pain (r = 0.656, P = 0.000)]. Conclusion: RA patients with high disease activity suffer from depression, anxiety, stress and poor QoL. Palliative care physicians and rheumatologists must be vested with the power to provide comprehensive care to these patients.

scholarly journals AB0236 DIFFERENCES AND DETERMINANTS OF PHYSICIAN’S AND PATIENT’S PERCEPTION IN GLOBAL ASSESSMENT OF RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1418.1-1418
Author(s):  
S. Azevedo ◽  
F. Guimarães ◽  
D. Almeida ◽  
D. Faria ◽  
J. Silva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatoid Factor ◽  
Global Assessment ◽  
Short Form ◽  
Biologic Treatment ◽  
Disease Evolution ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Of Disease Activity

Background:Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) are assessed as part of commonly used measures of disease activity in RA.1Both are important measures in treat-to-target strategies in Rheumatoid Arthritis (RA), but often provide discordant results.2,3This can provide an erroneous assessment of disease activity in patients under Biologic treatment and mislead treatment decisions, namely switches.Objectives:To assess differences and determinants of PtGA and PhGA in RA patients under biologic treatment.Methods:Cross-sectional study, including 46 patients with RA diagnosed according to the ACR/EULAR criteria, under biologic treatment, consecutively evaluated in day-care unit. Participants completed patient-reported outcomes (PROs), including PtGA, and sociodemographic characteristics. Physicians collected comorbidities and parameters of inflammatory activity (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]) and completed PhGA and disease activity score 28 with ESR (DAS28). SPSS was used for statistical analysis and significance level was defined as 2-sided p<0.05.Results:Clinical and laboratory characteristics of patients are shown in table 1. PtGA and PhGA were significantly different (36.1±27.6 mmvs8.7±14.2 mm, p< 0.001) and a positive discordance (PtGA>PhGA, more than 25mm in visual analogue scale [VAS]) was found in 54.3% of cases.PtGA had a correlation with PROs (Pain VAS, 36-Item Short Form Health Survey [SF-36], Health Assessment Questionnaire [HAQ], Functional Assessment of Chronic Illness Therapy [FACIT], EuroQol [EQ5D] and Hospital Anxiety and Depression Scale [HADS]), CRP, tender and swollen joint counts and an association with comorbidities like fibromyalgia or osteoarthritis (OA). No association was found between PtGA and age, sex, education level, profession, employment status, extra-articular manifestations, positivity of rheumatoid factor, ESR, years of disease evolution or number of biologic treatments. In multivariable analyse including SF-36, CRP, tender joints count and OA (R2adjusted= 0.672), the main predictors of PtGA were lower SF36, concomitant OA and higher CRP level.PhGA had a correlation with PtGA, pain VAS, CRP, tender and swollen joints. No association was found between PhGA and patient or physician age, patient or physician sex, extra-articular manifestations, positivity of rheumatoid factor, ESR level, years of disease evolution or number of biologic treatments. In multivariable analysis including ESR, tender and swollen joints count and CRP (R2adjusted= .800), the main predictors of PhGA were swollen joint count and higher CRP level.Conclusion:This study showed the variability implied on global assessment of RA activity. Overall PtGA is based on function and also in subjective and emotional experience of pain, whereas the PhGA is based on more objective measures, more related to disease activity.References:[1]Kanekoa Y. et al, Determinants of Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity in patients with rheumatoid arthritis: A post hoc analysis of overall and Japanese results from phase 3 clinical trials.Modern Rheumatology2018; 28(6):960–967[2]Furu M. et al. Discordance and accordance between patient’s and physician’s assessments in rheumatoid arthritis.Scand J Rheumatol.2014; 43(4):291-5.Ann Rheum Dis. 2016 Sep;75(9):1661-6. doi: 10.1136/annrheumdis-2015-208251. Epub 2015 Oct 22.[3]Portier A. et al, Patient-perceived flares in rheumatoid arthritis: A sub-analysis of the STRASS treatment tapering strategy trial.Joint Bone Spine. 2017; 84(5):577-581Disclosure of Interests:None declared

scholarly journals The Relationship Between Vitamin D Serum Levels and Rheumatoid Arthritis Activity in a Sample of Syrian Patients- a cross-sectional observational study

2021 ◽  
Author(s):  
Zaynab Alourfi ◽  
Nisreen Aldahhan
Keyword(s):  
Rheumatoid Arthritis ◽  
Vitamin D ◽  
Observational Study ◽  
Functional Disability ◽  
Serum Vitamin ◽  
Cross Sectional ◽  
Serum Vitamin D ◽  
Vitamin D Levels ◽  
The Relationship ◽  
Rheumatoid Arthritis Activity

Abstract Background. Rheumatoid Arthritis (RA) is a systemic auto immune disease that mainly affects joints. It might cause functional disability and increased morbidity and mortality.Vitamin D was reported to have an immunomodulation role in reducing the inflammation process in many auto immune diseases; RA is one of them.The aim was to determine the relationship between serum vitamin D levels and rheumatoid arthritis activity in a sample of Syrian patients.Methods This cross-sectional observational study was carried out in Al-Mouwasat and Al-Assad University Hospitals(Damascus University - Syria). RA patients were diagnosed according to the American College of Rheumatology (ACR) and the European League Against Rheumatism(EULAR)classification criteria for rheumatoid arthritis 2010 standards.Results Vitamin D was significantly higher in RA patients in remission (27.92 ± 13 ng/ml) than in patients with active RA (21.22 ± 13 ng/ml). There was an inverse relationship between serum vitamin D levels and RA activity.Conclusion Serum vitamin D levels were inversely correlated with RA activity in a sample of Syrian RA patients.

scholarly journals Adverse Events Profile of Low-dose Methotrexate in Nepalese Patients with Rheumatoid Arthritis: an Observational Study

2020 ◽  
Vol 18 (3) ◽  
pp. 360-365
Author(s):  
Shweta Nakarmi ◽  
Kalpana Pudasaini ◽  
Bhojraj Adhikari ◽  
Binit Vaidya
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Effect ◽  
Side Effects ◽  
Liver Function ◽  
Adverse Effects ◽  
Adverse Events ◽  
Observational Study ◽  
P Value ◽  
Function Tests ◽  
Patient Reported

Background: Methotrexate is considered as the anchor drug for the treatment of rheumatoid arthritis. However, various adverse effects limit its use leading to frequent discontinuation of treatment. This study aimed to evaluate the common adverse effects of methotrexate in patients with rheumatoid arthritis. Methods: A prospective observational study was conducted at National Center for Rheumatic Diseases from June 2018 to May 2019 among patients with rheumatoid arthritis using methotrexate monotherapy. Laboratory tests like liver function tests, renal function tests, complete blood count, C-reactive protein, erythrocyte sedimentation rate were done at baseline and every 3 months. Data on patients’ comorbidities, disease activity and side effects of drug were collected on every follow- up. Statistical analysis was carried out with the help of SPSS 23.0. Results: Out of 232 patients experiencing at least one adverse effect while on methotrexate monotherapy, 87.5% were female and mean age was 46.9±10.8 years. The mean dose of methotrexate was 16.6 ± 3.9 mg/week with the most frequently used dose of 20mg/week. Among the variety of adverse reaction observed, the most common was transaminitis (75.0%) with approximately 50.0% as isolated liver function abnormality, followed by nausea (19.4%), anorexia (12.9%), leukopenia (12.5%), oral ulcer (8.2%) and psychological intolerance (4.7%). Multiple regression analysis showed significant predictive value of body mass index for transaminitis (p-value 0.007). Conclusions: Asymptomatic liver function test derangement was the most frequent adverse-effect of methotrexate observed, whereas nausea and anorexia were the most common patient reported events. The frequent dose associated with side-effects in Nepalese patients was around 20mg/week. Keywords: Adverse events; methotrexate; Nepal; rheumatoid arthritis

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