scholarly journals Indirect Treatment Comparison of the Efficacy and Safety of Sarilumab Monotherapy in Rheumatoid Arthritis Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs

2019 ◽  
Vol 36 (4) ◽  
pp. 817-827 ◽  
Author(s):  
Ernest Choy ◽  
Nick Freemantle ◽  
Clare Proudfoot ◽  
Chieh-I Chen ◽  
Laurence Pollissard ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Indirect Treatment ◽  
Disease Modifying

scholarly journals Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

2017 ◽  
Vol 45 (4) ◽  
pp. 456-464 ◽  
Author(s):  
Alan Kivitz ◽  
Ewa Olech ◽  
Michael A. Borofsky ◽  
Beatriz Zazueta ◽  
Federico Navarro-Sarabia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Joint Disease ◽  
Published Data ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Serious Adverse Events ◽  
Disease Modifying

Objective.To evaluate the longterm efficacy and safety of subcutaneous tocilizumab (TCZ-SC) every 2 weeks (q2w) over 2 years in patients with rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARD).Methods.Patients (n = 656) were randomized 2:1 to TCZ-SC 162 mg q2w or placebo-SC q2w plus DMARD. After a 24-week double-blind period, patients (n = 457) were rerandomized to open-label TCZ-SC q2w by means of prefilled syringe or autoinjector. Escape therapy with weekly TCZ-SC was available for patients with inadequate efficacy from Week 12. Maintenance of response and safety to 2 years was assessed. Analyses used nonresponder imputation.Results.The American College of Rheumatology (ACR) 20 response after TCZ-SC was maintained beyond Week 24 and was > 70% at each timepoint. ACR50/70, 28-joint Disease Activity Score remission, and ≥ 0.30 decrease from baseline in the Health Assessment Questionnaire–Disability Index response rates were also maintained after Week 24 in the TCZ-SC arm (≥ 50%, > 25%,> 32% and > 56%, respectively). Following escape for inadequate efficacy, many patients achieved ACR20 at the end of the study, 35% after escape from TCZ-SC, and 63% from placebo. The rates of serious adverse events [(11.20/100 patient-years (PY)] including serious infections (3.25/100 PY) were stable through Week 96. No association between anti-TCZ antibody development and loss of efficacy or adverse events was observed.Conclusion.Efficacy and safety of TCZ-SC q2w was maintained up to 2 years and remained comparable with previously published data for intravenous TCZ. Dose escalation to weekly TCZ-SC was associated with ACR responses in prior nonresponders and was well tolerated.

Mixed Treatment Comparison of the Treatment Discontinuations of Biologic Disease-Modifying Antirheumatic Drugs in Adults with Rheumatoid Arthritis

2012 ◽  
Vol 46 (11) ◽  
pp. 1491-1505 ◽  
Author(s):  
Rishi J Desai ◽  
Richard A Hansen ◽  
Jaya K Rao ◽  
Tania M Wilkins ◽  
Elizabeth A Harden ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Meta Analysis ◽  
Mixed Treatment Comparison ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Biologic Dmards ◽  
Treatment Comparison ◽  
Mixed Treatment ◽  
Disease Modifying

BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has considerably changed treatment options for rheumatoid arthritis (RA) over the past decade. Very little information is available on comparative discontinuation rates of the biologics. OBJECTIVE: To compare treatment discontinuations for 9 biologic DMARDs in adults with RA. METHODS: We searched electronic databases through May 2012 to retrieve randomized controlled trials (RCTs) of patients with RA that compared biologic DMARDs with placebo or another biologic DMARD. The primary outcome was treatment discontinuation during the blinded phase of the trials, measured as overall withdrawals, withdrawals resulting from lack of efficacy, and withdrawals resulting from adverse events. Random-effects meta-analysis estimated the effect size for individual agents, and adjusted indirect comparisons were made between biologics using mixed treatment comparisons (MTC) meta-analysis. RESULTS: Forty-four trials were included in the analysis. In comparison with placebo, biologics were less likely to be withdrawn because of lack of efficacy (OR 0.22, 95% CI 0.17 to 0.27) and more likely to be withdrawn because of an adverse event (OR 1.41, 95% CI 1.16 to 1.70). Based on the MTC, certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates resulting from lack of efficacy than adalimumab, anakinra, and infliximab. Anakinra had higher relative withdrawal rates resulting from lack of efficacy than most other biologics. Certolizumab and infliximab had more, while etanercept had fewer, withdrawals because of adverse events than most other drugs. CONCLUSIONS: Based on MTC using data from RCTs, differences in discontinuation rates were observed, generally favoring certolizumab, etanercept, and rituximab over other biologic DMARDs. These potential differences need to be further explored in head-to-head trials or well-conducted observational studies.

scholarly journals Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

2019 ◽  
Vol 25 (3) ◽  
pp. 115-126 ◽  
Author(s):  
Paul Bird ◽  
William Bensen ◽  
Bassel El-Zorkany ◽  
Jeffrey Kaine ◽  
Bernadette Heizel Manapat-Reyes ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Inadequate Response ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying

scholarly journals Patients With Rheumatoid Arthritis With an Inadequate Response to Disease‐Modifying Antirheumatic Drugs at a Higher Risk of Acute Coronary Syndrome

2021 ◽  
Author(s):  
Chung‐Yuan Hsu ◽  
Yu‐Jih Su ◽  
Jia‐Feng Chen ◽  
Chi‐Chin Sun ◽  
Tien‐Tsai Cheng ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cardiovascular Disease ◽  
Acute Coronary Syndrome ◽  
Ischemic Stroke ◽  
Inadequate Response ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Coronary Syndrome ◽  
Disease Modifying

Background Cardiovascular disease is the most common cause of death in patients with rheumatoid arthritis. It is believed that using disease‐modifying antirheumatic drugs (DMARDs) to control inflammation can reduce the risk of cardiovascular disease. In this study, we investigated whether patients who responded differently to DMARDs might sustain different cardiovascular events. Methods and Results We designed a cohort study using the Chang Gung Research Database. We identified 7114 patients diagnosed with rheumatoid arthritis. After strict exclusion criteria, we collected 663 individuals as an inadequate response to DMARDs group. Then, 2034 individuals were included as the control group. The end point was composite vascular outcomes, including acute coronary syndrome or ischemic stroke. We used the inverse probability of treatment weighting to keep the covariates between these 2 groups well balanced. We compared the risk of these outcomes using the Cox proportional hazards model. The mean follow‐up time was 4.7 years. During follow‐up, there were 7.5% and 6.4% of patients with composite vascular outcomes in the DMARD‐inadequate response and control groups, respectively. There was no significant difference in the risk of composite vascular outcomes (95% CI, 0.94–1.41) and ischemic stroke (95% CI, 0.84–1.36). The risk of acute coronary syndrome was significantly higher in the DMARD‐inadequate response group (hazard ratio, 1.45; 95% CI, 1.02–2.05). Conclusions Patients with DMARD‐inadequate response rheumatoid arthritis have a higher risk of developing acute coronary syndrome than those whose disease can be controlled by DMARDs.

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