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Biologic Agents

Medications for Scleroderma, Arthritis, Autoimmune and Rheumatic Diseases
This page was written by Janey Willis. See Disclaimer.
Overview of Biologic Agents
Alemtuzumab (Campath)
TNF Inhibitors
Etanercept (Enbrel)
Infliximab (Remicade)
Rituximab (Rituxan)


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.
Biologic Therapy for Systemic Sclerosis (SSc): A Systematic Review. Anti-tumor necrosis factor-α agents may improve inflammatory arthritis and disability in SSc. The effect on skin score is uncertain. Adequately powered trials are needed to evaluate efficacy, and longitudinal studies are needed to evaluate longterm safety of these agents in SSc. Veerapong Phumethum. The Journal of Rheumatology February 1, 2011 vol. 38 no. 2 289-296.
Biologics in The Pipeline. Since 1998, eight biologic response modifiers, known as biologics, have been approved by the Food and Drug Administration for inflammatory forms of arthritis. Biologics are genetically engineered medications made from living organisms that are then used to treat humans. Two biologics were approved in 2009, and several more are in various stages of development and clinical testing. Mary Anne Dunkin Arthritis Today 1/11/10.

Alemtuzumab (Campath)

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.

TNF Inhibitors

Tumor Necrosis Factor (TNF) inhibitors include etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira)
Is there a role for TNFα antagonists in the treatment of Systemic Sclerosis (SSc)? Most of the experts do not recommend the routine use of TNF-α 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.
Biologic Therapy for Systemic Sclerosis (SSc): A Systematic Review. Anti-tumor necrosis factor-a agents may improve inflammatory arthritis and disability in SSc. The effect on skin score is uncertain. Adequately powered trials are needed to evaluate efficacy, and longitudinal studies are needed to evaluate long term safety of these agents in SSc. Phumethum V, (PubMed) J Rheumatol. 2010 Nov 1.
Treatment of patients with destructive arthritis with certolizumab pegol. Certolizumab pegol is a new anti-TNF-alpha inhibitor which has been approved for the treatment of rheumatoid arthritis since October 2009. In two individual case reports a remission of therapy refractive arthritis was achieved by administration of certolizumab pegol. (SpringerLink) T. Schmeiser. Zeitschrift fur Rheumatologie. June 9 2010. (Also see: Treatments for RA)
TNF-alpha antagonist therapy modify the tuberculin skin test response (TST). Tumour necrosis factor-alpha (TNF-α) antagonist drugs have been associated with increased risk of tuberculosis (TB). Increased TST responses in patients receiving TNF-α antagonists may be associated with the restoration of suppressed immune reactivity against TB antigens with the decreased disease activity. Tulin Cagatay. (SpringerLink) Rheumatology International. 27 March 2010. (Also see: Tuberculosis and Scleroderma)

Etanercept (Enbrel)

Enbrel. Enbrel (also known by its generic name etanercept) is a biologic medication approved in April 2004 by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis and in January 2002 for the treatment of psoriatic arthritis. It is also approved for treating rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis (arthritis affecting the spine). National Psoriasis Foundation.
Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial. Continuous treatment with etanercept over 2 years in a clinical setting improved clinical symptoms of PsA while reducing fatigue, improving work productivity, and ameliorating or eliminating disability. Dafna D. Gladman. The Journal of Rheumatology jrheum.100698. May 15, 2011.(Also see: Psoriatic Arthritis)
Development of sarcoidosis following etanercept treatment: a report of three cases. We present three patients who developed sarcoidosis while on etanercept treatment, and discuss if possible differences in cytokine profiles and T regulatory cell function in patients taking different TNF-α inhibitors may explain this paradox. (SpringerLink) I.M. Skoie. Rheumatology International. January 9 2010. (Also see: Causes of Sarcoidosis)

Infliximab (Remicade)

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. 9 September 2008. (Also see: Scleroderma Treatments)

Rituximab (Rituxan)

Rituxan (Targeted B-cell Therapy). Indications and Uses. FDA Warning. Rituxan.com.
Rapid infusion with rituximab: short term safety in systemic autoimmune diseases. In practise, the rapid infusion was an easy to use regime and the second infusion is of time sparing significance to health professionals. No unexpected side effects were observed in relation to the accelerated regime. Rheumatol Int. 2011 Nov 9.
Efficacy And Safety Of Rituximab In Patients With Diffuse Scleroderma (SSc): An Up To 2 Years Follow Up Study. Results indicate that long term treatment with RTX may favorably affect lung function and skin fibrosis in patients with SSc. D. Daoussis. EULAR 2011 FRI0403. Ann Rheum Dis 2011;70(Suppl3):480.
Successful treatment of steroid and cyclophosphamide-resistant diffuse scleroderma-associated interstitial lung disease with rituximab. We report herein a case of 47-year-old female with diffuse type of SSc with steroid and cyclophosphamide-resistant ILD that was successfully treated with RTX. Thus, we suggested that RTX could be an efficacious therapeutic modality for severe, conventional treatment-resistant SSc-associated ILD. (Springerlink) Wan-Hee Yoo. Rheumatology International. 01/07/10.
Is There a Role for B-cell Depletion as Therapy for Scleroderma (SSc)? A Case Report and Review of the Literature. Several basic research data underscore the potential pathogenic role of B-cells in SSc and clinical evidence suggests that Rituximab (RTX) might be a therapeutic option in SSc. Large-scale multicenter studies are needed to evaluate the potential clinical efficacy of RTX in SSc. Dimitrios Daoussis, MD Seminars in Arthritis and Rheumatism, 11 December 2009. (Also see: B-Cells)
REFILE-US rejects wider use of Roche arthritis drug. The Food and Drug Administration does not support approval of Rituxan -- in patients who have not previously received methotrexate or those who did not respond adequately -- due to the rare risk of progressive multifocal leukeoencephalopathy (PML). Reuters (Alibaba.com) 10/19/09.
Experience with rituximab (RTX) in scleroderma: results from a 1-year, proof-of-principle study. The results of this small scale study indicate that RTX may improve lung function in patients with SSc. Dimitrios Daoussis Rheumatology. May 15, 2009.
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