scholarly journals Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naïve to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001131 ◽  
Author(s):  
B Fautrel ◽  
B Zhu ◽  
P C Taylor ◽  
M van de Laar ◽  
P Emery ◽  
...  

ObjectiveTo compare improvement in pain and physical function for patients treated with baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy from randomised, methotrexate (MTX)-controlled trials in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/biologic (bDMARD)-naïve RA patients using matching-adjusted indirect comparisons (MAICs).MethodsData were from Phase III trials on patients receiving monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX. Pain was assessed using a visual analogue scale (0–100 mm) and physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI). An MAIC based on treatment-arm matching, an MAIC with study-level matching and Bucher’s method without matching compared change in outcomes between therapies. Matching variables included age, gender, baseline disease activity and baseline value of outcome measure.ResultsWith all methods, greater improvements were observed in pain and HAQ-DI at 6 months for baricitinib compared with adalimumab and tocilizumab (p<0.05). Differences in treatment effects (TEs) favouring baricitinib for pain VAS for treatment-arm matching, study-level matching and Bucher’s method, respectively, were −12, −12 and −12 for baricitinib versus adalimumab and −7, −7 and −9 for baricitinib versus tocilizumab; the difference in TEs for HAQ-DI was −0.28, −0.28 and −0.30 for adalimumab and −0.23, −0.23 and −0.26 for tocilizumab. For baricitinib versus tofacitinib, no statistically significant differences for pain improvement were observed except with one of the three methods (Bucher method) and none for HAQ-DI.ConclusionsResults suggest greater pain reduction and improved physical function for baricitinib monotherapy compared with tocilizumab and adalimumab monotherapy. No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.

2017 ◽  
Vol 76 (6) ◽  
pp. 1113-1136 ◽  
Author(s):  
Jackie L Nam ◽  
Kaoru Takase-Minegishi ◽  
Sofia Ramiro ◽  
Katerina Chatzidionysiou ◽  
Josef S Smolen ◽  
...  

ObjectivesTo update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations.MethodsMEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained.ResultsThe RCTs confirmed greater efficacy with a bDMARD+conventional synthetic DMARD (csDMARD) versus a csDMARDs alone (level 1A evidence). Using a treat-to-target strategy approach, commencing and escalating csDMARD therapy and adding a bDMARD in cases of non-response, is an effective approach (1B). If a bDMARD had failed, improvements in clinical response were seen on switching to another bDMARD (1A), but no clear advantage was seen for switching to an agent with another mode of action. Maintenance of clinical response in patients in remission or low disease activity was best when continuing rather than stopping a bDMARD, but bDMARD dose reduction or ‘spacing’ was possible, with a substantial proportion of patients achieving bDMARD-free remission (2B). RCTs have also demonstrated efficacy of several new bDMARDs and biosimilar DMARDs (1B).ConclusionsThis systematic literature review consistently confirmed the previously reported efficacy of bDMARDs in RA and provided additional information on bDMARD switching and dose reduction.


2009 ◽  
Vol 29 (04) ◽  
pp. 205-213
Author(s):  
M. Pierer ◽  
U. Wagner ◽  
C. Baerwald ◽  
O. Malysheva

ZusammenfassungRheumatische Erkrankungen sind schwere Erkrankungen, die mit anhaltenden Schmerzen einhergehen, zum Verlust an Lebensqualität, Funktion, Arbeitsfähigkeit und auch zur Verkürzung des Lebens führen können. Sie verursachen erhebliche Kosten für das Gesundheitssystem. Mehrere Biologika als neue „disease modifying antirheumatic drugs“ sind in die Therapie von rheumatoider Arthritis, Spondyloarthropathien, Psoriasis-Arthritis und idiopathischer juveniler Arthritis eingeführt worden. Es fand sich eine zum Teil große Effektivität der Biologika, wobei dieser Artikel sich auf die Anti-TNF-Therapien, nämlich Adalimumab, Etanercept und Infliximab, konzentriert. Weitere Anti-TNF Therapien sind in Entwicklung. Mit deren Zulassung ist in den nächsten Monaten zu rechnen.


2020 ◽  
pp. 33-38
Author(s):  
E. Yu. Gan ◽  
L. P. Evstigneeva

Purpose of the study. Assessing the association between the life quality of patients with Sjogren’s Disease and ongoing therapy with various disease-modifying antirheumatic drugs.Material and methods. The study was conducted on the basis of the regional rheumatology center of the consultative diagnostic clinic of the Sverdlovsk Regional Clinical Hospital No. 1. This work is based on the results of a simultaneous study of 74 patients with primary Sjogren’s Disease (SD), distributed in three comparison groups receiving various disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine. The diagnosis of SD was carried out according to European-American criteria AECGC (2002) [18]. In order to analyze the quality of life of patients with SD, the 36-Item Short Form Health Survey (SF‑36) was used. Statistical data processing was carried out using Statistica 7.0 program.Results. Assessment of the quality of life of patients with SD, which is an integrative criterion of human health and well-being, revealed the absence of statistically significant differences (p > 0.05) on eight scales and two health components of the SF‑36 questionnaire in the analyzed groups that differ in the treatment of disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine.Conclusions. The obtained data indicate an equivalent quality of life in SD patients treated with different disease-modifying antirheumatic drugs methotrexate, chlorambucil and hydroxychloroquine, and therefore hydroxychloroquine can be considered as an alternative basic therapy in patients with SD with certain limitations and contraindications methotrexate and chlorambucil.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 862.2-863
Author(s):  
M. K. Chung ◽  
J. S. Park ◽  
H. S. Lim ◽  
C. H. Lee ◽  
J. Lee

Background:Rheumatoid arthritis (RA) predominantly affects women and has a significant impact on childbearing. Several population-based studies identifying incidence, prevalence, and medication use of RA have been reported, yet epidemiological studies focusing on women with RA in childbearing years are missing.Objectives:We aimed to identify the incidence, prevalence and medication use of RA among Korean women in childbearing years.Methods:From National Health Insurance Service (NHIS) data (2009-2016), containing inpatient and outpatient claim information for approximately 97% of the Korean population, we identified 9,217,139 women aged between 20-44 years. Incidence and prevalence of RA in the specific sociodemographic group of women in childbearing age were analyzed, and the prevalence of medication prescription were compared between women with RA and controls without rheumatic diseases such as RA, systemic lupus erythematosus, and ankylosing spondylitis. Individuals with RA were defined by the presence of International Classification of Disease, 10th revision code, M05. The medication use was defined as receiving > 90days prescriptions of NSAIDs, corticosteroids (CSs), and conventional synthetic (cs) disease modifying antirheumatic drugs (DMARDs) or > 1day prescription of biologic (b) DMARDs.Results:Total 24,590 women with RA were identified. The average incidence of RA during 2011-2016 among women in childbearing years was 24.1/100,000 person-years (PYs) (95% CI 20.91-27.31) with a yearly increase from 20.99/100,000 PYs in 2011 to 28.38/100,000 PYs in 2016. The average prevalence of RA during 2009-2016 among women in childbearing years was 105.2/100,000 PYs (95% CI 99.0-111.5) with a minimum of 95.7/100,000 PYs in 2009 and a maximum of 110.5/100,000 PYs in 2016. There were increasing trends in both incidence and prevalence of RA according to age among women in childbearing years peaking in the age group of 40-44 years. The prescriptions of NSAIDs, CSs, csDMARDs and bDMARDs were more frequent in women with RA than controls (NSAIDs; 94.21% vs 21.79%, CSs; 83.65% vs 4.28%, csDMARDs; 91.23% vs 0.41%, bDMARDs; 0.11% vs 0%, p<0.001).Conclusion:The incidence and prevalence of RA are high among Korean women in childbearing years, and medication use was significantly more frequent in this specific population than controls. High disease burden is imposed upon women in childbearing years.References:[1] Won S, Cho SK, Kim D, Han M, Lee J, Jang EJ, Sung YK, Bae SC: Update on the prevalence and incidence of rheumatoid arthritis in Korea and an analysis of medical care and drug utilization. Rheumatol Int 2018, 38(4):649-656.[2] Smeele HTW, Dolhain R: Current perspectives on fertility, pregnancy and childbirth in patients with Rheumatoid Arthritis. Seminars in arthritis and rheumatism 2019, 49(3s):S32-s35.Table 1.Medication use among women with RA and controls in childbearing age between 20-44 years during 2009-2016Control(n=155,486)RA(n=23,756)n(%)n(%)PNSAIDs33,887(21.79)22,380(94.21)<.0001Steroids6,653(4.28)19,871(83.65)<.0001csDMARDs634(0.41)21,673(91.23)<.0001bDMARDs0(0.00)27(0.11)<.0001RA, rheumatoid arthritis; NSAID, non-steroidal anti-inflammatory drug; cs, conventional synthetic; b, biologic; DMARDs, disease modifying antirheumatic drugsDisclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1437.1-1438
Author(s):  
A. Fazaa ◽  
H. Boussaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
L. Souabni ◽  
...  

Background:In the recent decades, biological disease-modifying antirheumatic drugs (bDMARDs) have significantly improved management and quality of life in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA).However, bDMARDs have also a strong influence on the immune system, leading to a risk of serious infection. Reactivation of hepatitis B (HBV) and C (HCV) virus is one of the most redoubtable complications of these immunosuppressive agents.Objectives:The aims of this study were to determine the screening rate for hepatitis B and C before starting a biological treatment and to examine the prevalence of their markers in patients with RA or SpA.Methods:Our study evaluated all patients included in the Tunisian registry BINAR (Biologic National Registry) since 2018 who had RA (ACR/EULAR 2010) or SpA (ASAS criteria) aged with more than eighteen years old and receiving their first bDMARDs during the two past years.The following information were retrieved from the registry: demographic data on the patients, disease parameters, medication, HBV surface antigen (HBs Ag), antibody to HBs Ag (Anti HBs), antibody to HBV core antigen (Anti HBc), HBV-DNA, antibody to HCV (anti HCV) status and liver function tests (AST: aspartate aminotransferase; ALT:alanine aminotransferase).Results:A total of 298 patients was included, 111 men and 178 women, with a mean age of 49.2 ± 14.1 years old [18-79]. Among them, 58.7% were diagnosed with RA and 41.3% were diagnosed with SpA. The mean disease duration was 6.7±3.5 years [1-12] in patients with RA and 6.5±3 [1-12] in patients with SpA. The mean Disease Activity Score (DAS28) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were respectively of 4.9±1.5 [1-8] and 4.1±1.8 [0-9].Therapeutically, 167 patients (56%) were on Prednisone at a mean daily posology of 8.2±5.4 mg [4-60] and 70.3% on conventional synthetic disease modifying antirheumatic drug (csDMARD) in association with bDMARDs. It was about Tumor Necrosis Factor alpha antibodies (anti TNF a) in 87.9% of cases, Tocilizumab in 10.4% of cases and Rituximab in 5% of cases.A screening of HBV was performed in 286 patients (96%). Ag HBs was positive in two cases (0.7%), and anti-HBc was positive in 16 cases (6.4%) which indicate a prior HBV infection. Fifteen patients (6%) were immunized with positive anti HBs. HBV-DNA was measured in 177 cases (66.8%) and was positive in 15 patients (6%).HCV infection was searched in 282 patients (94.6%) and anti-HCV was negative in all cases.AST and ALT mean rates were respectively of 18.3 [2-108] and 17.9 UI/l [2-74]. A perturbation of these liver function tests was observed in 13 patients (4.4%).Conclusion:Screening for hepatitis B and C were performed respectively in 96% and 94% of our Tunisian patients before receiving any bDMARDs. This should be systematic to avoid HBV reactivation which can lead to fulminant hepatic failure with a severe prognosis.Disclosure of Interests:None declared


Sign in / Sign up

Export Citation Format

Share Document