|Overview of Biologic Agents
Etanercept (Enbrel, Benepali)
Biologics or biologic agents are biologic response modifying agents that block specific pathways and signals of inflammation. Some of the biologics used to treat rheumatic diseases include etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), abatacept (Orencia), and rituximab (Rituxan). (Also see What is Scleroderma?, Medical Overview, and Medications for Scleroderma, Arthritis, Autoimmune and Rheumatic Diseases)
Different biologics block different arm of the immune system. For example, etanercept, infliximab, and adalimumab block tumor necrosis factor (TNF), abatacept blocks an interaction between T cells and macrophages, and rituximab effectively eliminates B cells for several months.
Risk of congenital anomalies in infants born to women with autoimmune disease using biologics before or during pregnancy: a population-based cohort study. These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of congenital anomalies. PubMed, Clin Exp Rheumatol, 2019 Nov-Dec;37(6):976-982.
Evaluation of response criteria in rheumatoid arthritis treated with biological disease–modifying antirheumatic drugs. EULAR response criteria overestimate the response under Interleukin-6 inhibitors treatment because the acute–phase reactants improvement largely contributes to the Disease Activity Score 28 improvement. PubMed, Arthritis Care Res (Hoboken), 05/06/2019.
The Effect of Pregnancy on Disease Activity in Patients with Psoriatic Arthritis. Continuation of biologics therapy was associated with a low level of disease activity and a low probability of flare during pregnancy. PubMed, J Rheumatol, 2018 Dec;45(12):1651-1655. (Also see Psoriasis and Psoriatic Arthritis)
Association between autophagy and inflammation in patients with rheumatoid arthritis (RA) receiving biologic therapy. Elevated autophagy with significant correlation to inflammation suggests the involvement of autophagy in RA pathogenesis. PubMed, Arthritis Res Ther, 2018 Dec 5;20(1):268. (Also see Treatments for Rheumatoid Arthritis)
Drug Utilization Patterns and Adherence in Patients on Systemic Medications for the Treatment of Psoriasis: A Retrospective Comparative Cohort Study. We report greater adherence in new users of biologics when compared to methotrexate. PubMed, J Am Acad Dermatol, 07/04/2018. (Also see Psoriasis and Psoriatic Arthritis)
Precision medicine using different biological DMARDs based on characteristic phenotypes of peripheral T helper cells in psoriatic arthritis. Strategic treatment in which different bDMARDs were selected according to phenotypic differences in helper T cells showed significantly higher efficacy. PubMed, Rheumatology (Oxford), 04/02/2018. (Also see Psoriasis and Psoriatic Arthritis)
Residual disease activity (RDA) in rheumatoid arthritis (RA) patients treated with subcutaneous biologic drugs that achieved remission or low disease activity (LDA). RDA in RA was present even in patients with remission or LDA, especially for the patient's reported outcome and impaired function was also present in a significantly rate of patients. PubMed, Clin Rheumatol, 02/21/2018. (Also see Treatments for Rheumatoid Arthritis)
Biologics or tofacitinib for people with rheumatoid arthritis (RA) unsuccessfully treated with biologics: a systematic review and network meta-analysis. Biologic or tofacitinib use was associated with clinically meaningful and statistically significant benefits compared to placebo or an active comparator among people with RA previously unsuccessfully treated with biologics. PubMed, Cochrane Database Syst Rev, 2017 Mar 10;3:CD012591. (Also see Treatments for Rheumatoid Arthritis)
‘Generic’ Biologic Drugs Appear Comparable to Brand–Name Counterparts. New analysis suggests common and costly medications made from living cells can be equivalent even when manufactured by different company. Johns Hopkins News Release, 08/01/2016.
Use of Biologics in Sjögren's Syndrome. In this review, we summarize the current evidence regarding B–cell targeted and anti–TNF therapies and provide an overview of promising drugs in the pipeline. Rheumatic Disease Clinics, 06/21/2016. (Also see Treatments for Symptoms of Sjögren's Syndrome)
Abatacept in Early Diffuse Cutaneous Systemic Sclerosis – Results of a Phase 2 Investigator-Initiated, Multicenter, Double-Blind Randomized Placebo-Controlled Trial. In this Phase 2 trial, abatacept was well tolerated, but change in modified Rodnan skin score was not statistically significant. PubMed, Arthritis Rheumatol, 07/24/2019.
FDA Alert: Alemtuzumab (marketed as Campath) Information. Three patients in a clinical study of the drug Campath for the treatment of Multiple Sclerosis (MS) developed severe idiopathic thrombocytopenic purpura (ITP). One of the patients died. U.S. Food and Drug Administration.
Alemtuzumab (Campath): Side Effects. Safety data, except where indicated, are based on 149 patients with B-CLL enrolled in studies of Campath as a single agent administered at a maintenance dose of 30 mg intravenously three times weekly for 4 to 12 weeks. RxList.
Benepali® (Etanercept) is the first etanercept biosimilar referencing Enbrel ® approved in the European Union (EU). It is indicated for adults in the EU to treat moderate to severe active rheumatoid arthritis, psoriasis and psoriatic arthritis, and spondyloarthritis. Biogen.
Enbrel® (etanercept) treats moderate to severe plaque psoriasis from inside the body, rather than at the surface where you see skin symptoms. It works on your immune system to help stop skin cells from growing too quickly. Amgen.
Low Doses of Etanercept (ETN) Can Be Effective to Maintain Remission in Psoriatic Arthritis (PsA) Patients. The main reasons that hinder the dosing interval increase in ETN in PsA patients are peripheral polyarthritis pattern and exacerbation of cutaneous manifestations. PubMed, J Clin Rheumatol, 2018 Apr;24(3):127-131. (Also see Psoriasis and Psoriatic Arthritis)
The effect of etanercept on traditional metabolic risk factors for cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA). Patients with RA are at an increased risk of CVD and treatment with etanercept did not adversely affect levels of metabolic risk factors for CVD in patients with RA. PubMed, Clin Rheumatol, 10/05/2016. (Also see Treatments for Rheumatoid Arthritis)
Infliximab (Remicade). Patients treated with REMICADE are at increased risk for infections, including progression to serious infections leading to hospitalization or death. RxList.
An Open-Label Pilot Study Of Infliximab Therapy In Diffuse Cutaneous Systemic Sclerosis (dcSSc). In dcSSc infliximab did not show clear benefit at 26 weeks but was associated with clinical stabilisation and fall in two laboratory markers of collagen synthesis. The frequency of suspected infusion reactions may warrant additional immunosuppression in any future studies in SSc. C. P. Denton. (Also see Scleroderma Treatments)
Case Report: Successful treatment of infliximab in a patient with scleroderma. Signs and symptoms were continued improving during the course of treatment and skin biopsy showed significant reduction in fibroplasia finally. PubMed, Medicine (Baltimore).
RITUXAN® (Rituximab) is approved for treatment of rheumatoid arthritis, granulomatosis with polyangiitis (GPA) (formerly Wegener's Granulomatosis), microscopic polyangiitis (MPA), non-Hodgkin’s lymphoma (NHL), and chronic lymphocytic leukemia (CLL). Biogen and Genentech.
Rituxan® (Targeted B-cell Therapy). Indications and Uses. FDA Warning. Rituxan.com.
B cell depletion treatment decreases CD4+IL4+ and CD4+CD40L+ T cells in patients with systemic sclerosis (SSc). Our study demonstrates a link between rituximab treatment and CD4+IL4+ T cell decrease both in the skin and peripheral blood of patients with SSc. PubMed, Rheumatol Int, 06/21/2019. (Also see B Cells and T Cells)
Effects of treatment with rituximab on microcirculation in patients with long–term systemic sclerosis. Rituximab improves microcirculation in long–term SSc and stabilization and reduced progression of microcirculation abnormalities were achieved. PubMed, BMC Res Notes, 2018 Dec 10;11(1):874. (Also see Clinical Trials)
Rituximab for refractory rapidly progressive interstitial lung disease (RP–ILD) related to anti-MDA5 antibody–positive amyopathic dermatomyositis. Our results suggest that RTX may be a useful therapy for anti-MDA5 Ab-positive ADM associated with RP–ILD, although infection is the major risk. PubMed, Clin Rheumatol, 04/30/2018. (Also see Treatments for Dermatomyositis)
Two years follow–up of an open–label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc. PubMed, Acta Clin Belg, 2017 Sep 11:1-7.
A multi–center, open–label, comparative study of B–cell depletion therapy with Rituximab (RTX) for systemic sclerosis–associated interstitial lung disease. Our data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc and randomized controlled studies are highly needed. Seminars in Arthritis and Rheumatism, 11/05/2016.
Disease Activity, Glucocorticoid (GC) Exposure, and Rituximab Determine Body Composition Changes during Induction Treatment of ANCA–Associated Vasculitis (AAV). Findings suggest that changes in BMI are independently associated with improvements in disease activity as well as GC exposure in AAV and rituximab may also have effects on BMI independent of its impact on disease activity. PubMed, Arthritis Care Res (Hoboken), 10/01/2016. (Also see Vasculitis)
(Case Report) Rituximab (RTX) for eosinophilic granulomatosis with polyangiitis with severe vasculitic neuropathy: Case report and review of current clinical evidence. RTX seems to be effective in cases of severe EGPA refractory to standard of care immunosuppressive treatment, although support comes from case reports and non-controlled studies. PubMed, Semin Arthritis Rheum.
Tumor Necrosis Factor (TNF) inhibitors include etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira)
Improved patient–reported outcomes (PROs) in patients with psoriatic arthritis (PsA) treated with abatacept: results from a phase 3 trial. Abatacept treatment improved PROs in patients with PsA versus placebo, with better results in elevated baseline C-reactive protein and tumour necrosis factor inhibitor– naïve subpopulations. BMC Journals, Arthritis Research & Therapy, 12/06/2018. (Also see Psoriasis and Psoriatic Arthritis)
Risk of active tuberculosis in patients with inflammatory arthritis receiving TNF inhibitors (TNFi): a look beyond the baseline tuberculosis screening protocol. ‘Early TB’ was exceeded by TB occurring after 1 year of TNFi treatment, thereby, suggesting that further TB prevention measures were required. PubMed, Clin Rheumatol, 2018 Sep;37(9):2391-2397. (Also see Extrapulmonary Tuberculosis)
Use of biological drugs in patients with psoriasis (PsO) and psoriatic arthritis (PsA) in Italy: Results from the PSONG survey. Adalimumab could be the best therapeutic option over other anti–TNF agents for the treatment of PsO and PsA patients. PubMed, Dermatol Ther, 12/07/2017. (Also see Psoriasis and Psoriatic Arthritis)
Response to Treatment with TNFα Inhibitors in Rheumatoid Arthritis Is Associated with High Levels of Granulocyte–macrophage colony–stimulating factor (GM-CSF) and GM-CSF+ T Lymphocytes. The use of biomarker signatures of distinct pro-inflammatory pathways could lead to evidence-based prescription of the most appropriate biological therapies for different RA patients. PubMed, Clin Rev Allergy Immunol, 05/09/2017. (Also see Treatments for Rheumatoid Arthritis)
Biosimilars: implications for rheumatoid arthritis therapy. Five TNF inhibitor biosimilars have now been approved, and many other biosimilars to treat rheumatoid arthritis and other inflammatory diseases are in development. PubMed, Curr Opin Rheumatol, 03/16/2017. (Also see Treatments for Rheumatoid Arthritis)
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