Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis

Lee, Young Ho; Bae, Sang Cheol

doi:10.1007/s00393-016-0133-z

Cited by 3 publications

(1 citation statement)

References 32 publications

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“…DMARDs include methotrexate (MTX), sulfasalazine, hydroxychloroquine and leflunomide, which are the cornerstone treatment for Rheumatoid arthritis (RA). An alternative drug choice for RA is biological agents (biologics) such as etanercept, but they are more expensive ( Lee and Bae, 2016 ). DMARDs remain as the primary drug choice for RA treatment ( Schmitz et al, 2011 ).…”

Section: Methodsmentioning

confidence: 99%

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis

Wang

Rastegar-Mojarad

et al. 2018

Front. Pharmacol.

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Multiple data sources are preferred in adverse drug event (ADEs) surveillance owing to inadequacies of single source. However, analytic methods to monitor potential ADEs after prolonged drug exposure are still lacking. In this study we propose a method aiming to screen potential ADEs by combining FDA Adverse Event Reporting System (FAERS) and Electronic Medical Record (EMR). The proposed method uses natural language processing (NLP) techniques to extract treatment outcome information captured in unstructured text and adopts case-crossover design in EMR. Performances were evaluated using two ADE knowledge bases: Adverse Drug Reaction Classification System (ADReCS) and SIDER. We tested our method in ADE signal detection of conventional disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients. Findings showed that recall greatly increased when combining FAERS with EMR compared with FAERS alone and EMR alone, especially for flexible mapping strategy. Precision (FAERS + EMR) in detecting ADEs improved using ADReCS as gold standard compared with SIDER. In addition, signals detected from EMR have considerably overlapped with signals detected from FAERS or ADE knowledge bases, implying the importance of EMR for pharmacovigilance. ADE signals detected from EMR and/or FAERS but not in existing knowledge bases provide hypothesis for future study.

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Section: Methodsmentioning

confidence: 99%

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis

Wang

Rastegar-Mojarad

et al. 2018

Front. Pharmacol.

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An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs

et al. 2019

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Objectives The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response. Methods Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units). Results A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: −2.3 vs −2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission. Conclusion Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.

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Two new drugs for rheumatoid arthritis

2017

DTB

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Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease that causes inflammation and destruction of the joints. It can also affect the eyes, the heart and the lungs and is associated with significant disability and increased mortality. RA is estimated to affect just under 1% of the population aged over 16 years, equating to more than 400,000 people in the UK. ▼Baricitinib (Olumiant) and ▼tofacitinib (Xeljanz) were launched in the UK in April 2017 and represent a new therapeutic class of medicines known as targeted synthetic disease modifying antirheumatic drugs. Here, we review the evidence for the safety and effectiveness of these new oral agents.

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Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis

Abstract: CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.

Cited by 3 publications

References 32 publications

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis

An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs

Two new drugs for rheumatoid arthritis

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