|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.
‘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)
B-cell survival factors in autoimmune rheumatic disorders. The information on the use of biologic agents blocking B-cell activating factor and A proliferation inducing ligand for patients with lupus, rheumatoid arthritis, Sjögren’s syndrome and myositis has been updated. Therapeutic Advances in Musculoskeletal Disease, 07/17/2015.
Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Standard-dose and high-dose biological drugs are associated with an increase in serious infections in rheumatoid arthritis, although low-dose biological drugs are not. The Lancet, 05/19/2015.
Indirect Comparison Between Subcutaneous Biologic Agents in Ankylosing Spondylitis (AS). Golimumab, compared to placebo, may be the drug that provides the highest probability of achieving ASAS20 response in AS patients naive to biologic treatments at 12 weeks. PubMed, Clin Drug Investig, 2014 Nov 12.
New treatments for inflammatory rheumatic disease. This article describes the new and upcoming treatment options for rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, and gout to dissect what we should be aware of when discussing these new and promising molecules. PubMed, Immunol Res, 2014 Nov 9.
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. 11/05.
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.
Efficacy and Safety of Etanercept in the Treatment of Scleroderma-Associated Joint Disease. Joint pain and stiffness are common complaints in scleroderma and may represent a true inflammatory synovitis in a subset of patients1. Yet effective treatment remains problematic. We describe the efficacy and safety of etanercept in scleroderma patients with active joint disease. The Journal of Rheumatology, Johns Hopkins Scleroderma Center.
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.
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)
Treatment of moderate rheumatoid arthritis with different strategies in a health resource-limited setting: a cost-effectiveness analysis in the era of biosimilars. This study explores the cost-effectiveness of reduced doses or discontinuation of etanercept biosimilar (Yisaipu) in patients with moderately active rheumatoid arthritis (RA). PubMed, Clin Exp Rheumatol, 12/01/2014. (Also see Treatments for Rheumatoid Arthritis)
The effect of rituximab therapy on immunoglobulin levels in patients with multisystem autoimmune disease. In multi-system autoimmune disease, prior cyclophosphamide exposure and glucocorticoid therapy but not cumulative rituximab dose was associated with an increased incidence of hypogammaglobulinaemia and repeat dose rituximab therapy appears safe with judicious monitoring. PubMed, BMC Musculoskelet Disord, 2014 May 25;15(1):178.
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. Ann Rheum Dis, . (Also see Scleroderma Treatments)
People with serious infections should not receive Rituxan. It is not known if it is safe or effective in children.
RITUXAN® (Rituximab) is approved for treatment of rheumatoid arthritis, granulomatosis with polyangiitis (GPA) (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.
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)
Rituximab Safe for Up to 11 Years in Rheumatoid Arthritis (RA). Rituximab had a consistent safety profile through multiple courses used in treating (RA) during 11 years of observation and was not associated with excess infection rates, cardiac events, or malignancies. Medscape, 09/01/2015. (Also see Treatments for Rheumatoid Arthritis)
Effects and safety of rituximab (RTX) in systemic sclerosis (SSC): an analysis from the European Scleroderma Trial and Research (EUSTAR) group. The comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis. PubMed, Ann Rheum Dis, 2015 Jun;74(6):1188-94.
Successful use of Rituximab in a patient with recalcitrant multisystemic eosinophilic granulomatosis with polyangiitis (EGPA). Few cases are reported in the literature about the role of Rituximab in EGPA, of which only one described retinal artery occlusion as a presentation of a recently treated patient with EGPA. PubMed, BMJ Case Rep, 05/15/2015.
(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)
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)
Malignancies rare following anti-TNF-a therapy; most patients discontinue biologics. A small number of patients developed a malignancy while receiving anti-tumor necrosis factor-alpha treatment for an autoimmune disease, and most who did discontinued treatment with biologic agents. Healio Rheumatology, 07/30/2015.
Is there a role for TNFa antagonists in the treatment of Systemic Sclerosis (SSc)? Most of the experts do not recommend the routine use of TNF-a antagonists in systemic sclerosis. Arthritis might be a potential indication, although controlled clinical trials are needed before general recommendations can be given. Clin Exp Rheumatol, 2011 Mar-Apr;29(2 Suppl 65):S40-5.
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