Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

Divonne, Maïté de La Forest; Gottenberg, Jacques Éric; Salliot, Carine

doi:10.1016/j.jbspin.2016.02.028

Cited by 58 publications

(45 citation statements)

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“…Patients using bDMARDs compared with those using csDMARDs have an increased risk of severe infections [64][65][66][67][68]. In general, different bDMARDs have similar levels of safety.…”

Section: General Principlesmentioning

confidence: 99%

2017 recommendations of the Brazilian Society of Rheumatology for the pharmacological treatment of rheumatoid arthritis

et al. 2018

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The objective of this document is to provide a comprehensive update of the recommendations of Brazilian Society of Rheumatology on drug treatment of rheumatoid arthritis (RA), based on a systematic literature review and on the opinion of a panel of rheumatologists. Four general principles and eleven recommendations were approved. General principles: RA treatment should (1) preferably consist of a multidisciplinary approach coordinated by a rheumatologist, (2) include counseling on lifestyle habits, strict control of comorbidities, and updates of the vaccination record, (3) be based on decisions shared by the patient and the physician after clarification about the disease and the available therapeutic options; (4) the goal is sustained clinical remission or, when this is not feasible, low disease activity. Recommendations: (1) the first line of treatment should be a csDMARD, started as soon as the diagnosis of RA is established; (2) methotrexate (MTX) is the first-choice csDMARD; (3) the combination of two or more csDMARDs, including MTX, may be used as the first line of treatment; (4) after failure of first-line therapy with MTX, the therapeutic strategies include combining MTX with another csDMARD (leflunomide), with two csDMARDs (hydroxychloroquine and sulfasalazine), or switching MTX for another csDMARD (leflunomide or sulfasalazine) alone; (5) after failure of two schemes with csDMARDs, a bDMARD may be preferably used or, alternatively a tsDMARD, preferably combined, in both cases, with a csDMARD; (6) the different bDMARDs in combination with MTX have similar efficacy, and therefore, the therapeutic choice should take into account the peculiarities of each drug in terms of safety and cost; (7) the combination of a bDMARD and MTX is preferred over the use of a bDMARD alone; (8) in case of failure of an initial treatment scheme with a bDMARD, a scheme with another bDMARD can be used; in cases of failure with a TNFi, a second bDMARD of the same class or with another mechanism of action is effective and safe; (9) tofacitinib can be used to treat RA after failure of bDMARD; (10) corticosteroids, preferably at low doses for the shortest possible time, should be considered during periods of disease activity, and the risk-benefit ratio should also be considered; (11) reducing or spacing out bDMARD doses is possible in patients in sustained remission.

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“…Patients using bDMARDs compared with those using csDMARDs have an increased risk of severe infections [64][65][66][67][68]. In general, different bDMARDs have similar levels of safety.…”

Section: General Principlesmentioning

confidence: 99%

2017 recommendations of the Brazilian Society of Rheumatology for the pharmacological treatment of rheumatoid arthritis

et al. 2018

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“…20 Increase of infection and serious infection risk after TNF inhibitors was first seen in clinical trials with patients with RA and confirmed in a meta-analysis of these trials. 15,21 It was further confirmed by metaanalyses of observational studies of patients with RA, including data from biologic registries 22,23 with calculated RR between 1.37 and 1.48 for serious infections. Yet it may not be true for patients with ankylosing spondylitis treated by TNF inhibitors, although data are derived mainly from randomized controlled trials.…”

Section: Infectionsmentioning

confidence: 80%

“…Although some studies suggest an increased risk of cancer in patients using TNF inhibitors, 21,67 most of the meta-analyses exclude an increase in the total risk of cancer. 23,[68][69][70][71][72] Still, there are special concerns regarding the risk of malignant melanoma, 73 nonmelanoma skin cancers, 67,68,70 and lymphomas 74,75 after TNF inhibitor treatment. These data come from patients with RA, despite the fact that this group of patients may present an increased baseline risk for specific cancers compared to the general population (such as lymphoma or lung cancer) [76][77][78] and TNF inhibitor therapy in RA is typically characterized by concomitant use of nonbiological DMARDs, which may cause a possible synergistic effect on the risk of cancer.…”

Section: Malignanciesmentioning

confidence: 99%

“…Meanwhile, the growing amount of evidence from RA studies indicates that TNF inhibitors are irrelevant to HF [146][147][148] or can even reduce the risk of HF. [149][150][151] Furthermore, meta-analyses of observational studies show a reduced risk of all cardiovascular events, 23,152 myocardial infarction, and cerebrovascular accidents in patients with RA treated with TNF inhibitors. 152 Unfortunately, there are no data regarding TNF inhibitors' safety in terms of HF in patients with ankylosing spondylitis.…”

Section: Sarcoidosismentioning

confidence: 99%

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The Safety Profile of Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis: Are TNF Inhibitors Safer Than We Thought?

Wroński

Fiedor

2018

The Journal of Clinical Pharma

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Tumor necrosis factor (TNF) inhibitors significantly improved the treatment options for patients with ankylosing spondylitis. Unfortunately, currently, there is no strategy for sustaining remission of the disease with TNF inhibitors; after discontinuation, a high percentage of patients experience flares in a short time. Therefore, up‐to‐date, long‐term use of TNF inhibitors in patients with ankylosing spondylitis remains necessary. For this reason, the issue of the long‐term safety of TNF inhibitors in patients with ankylosing spondylitis raises concerns. Although TNF inhibitors are well established in ankylosing spondylitis treatment, the majority of studies on TNF inhibitors’ safety have been performed in patients with rheumatoid arthritis. Until recently, there were very few studies of TNF inhibitors’ safety in ankylosing spondylitis. Meanwhile, TNF inhibitors appear to have different safety profiles in ankylosing spondylitis and rheumatoid arthritis. In this review, we describe available data on the occurrence of adverse events associated with TNF inhibitor treatment in ankylosing spondylitis, including serious adverse events, infections, serious infections, tuberculosis, opportunistic infections, hepatitis B reactivation, malignancies, laboratory test abnormalities, autoimmune diseases, paradoxical adverse events, and heart failure.

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“…The rate of lymphoma in RA patients treated with biologic agents is similar to those who have never been treated. Those with prior cancer diagnoses are not at increased risk of recurrence [63,64]. In 2008, a report from the FDA raised concerns about biologic agents and neoplastic disease in pediatric CrD and JIA patients.…”

Section: Neoplastic Diseasementioning

confidence: 99%

Immunotherapeutic Biologic Agents to Treat Autoinflammatory Diseases

Ostrov¹

2017

Immunotherapy - Myths, Reality, Ideas, Future

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In recent years, innovative treatment for patients with autoimmune and autoinflammatory diseases has advanced in concert with our increased understanding of molecular and clinical immunology. Deeper understanding of autoimmunity has allowed for the development of cutting-edge biologic drugs for patients with relatively common autoimmune diseases. During this same period, knowledge regarding the molecular bases of autoinflammatory genetic diseases has also greatly expanded. Biologic immunotherapeutic agents developed for autoimmune diseases that primarily target cytokines that are also dysregulated in the uncommon autoinflammatory diseases are the focus of this article. In the following pages, selected genetic autoinflammatory diseases and key immunotherapeutic treatment approaches are addressed. The current understanding of these diseases and mechanisms by which therapeutic agents may benefit patients are reviewed. Indications, risks, and additional considerations for the use of these agents in treatment of autoinflammatory disorders are addressed as well.

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Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

Cited by 58 publications

References 58 publications

2017 recommendations of the Brazilian Society of Rheumatology for the pharmacological treatment of rheumatoid arthritis

2017 recommendations of the Brazilian Society of Rheumatology for the pharmacological treatment of rheumatoid arthritis

The Safety Profile of Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis: Are TNF Inhibitors Safer Than We Thought?

Immunotherapeutic Biologic Agents to Treat Autoinflammatory Diseases

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