| Medications for Scleroderma, Arthritis,
Autoimmune and Rheumatic Diseases |
| This page was written by Janey Willis and has not yet been medically edited. See Disclaimer. |
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| Disease-Modifying Anti_Rheumatic Drugs (DMARDs) |
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| Overview of DMARDs |
| DMARDs are Disease-Modifying Anti-Rheumatic Drugs used for a variety of conditions from Irritable Bowel Disease to scleroderma. DMARDs include immunosuppressants, antimalarial drugs, anti-inflammatory metals, and biologic agents. |
| Immunosuppressants fall under a category of drugs referred to as DMARDs (Disease-Modifying Anti-Rheumatic Drugs). ISN. |
| Scleroderma Treatments and Clinical Trials ISN. |
| Combination Therapy with DMARDS |
| Tolerability of methotrexate (MTX) and leflunomide (LEF) combination therapy for inflammatory arthritis in routine clinical practice: results of a four-centre study. The contrasting modes of action of MTX and LEF make them attractive candidates for use in combination with the potential to provide additive or synergistic actions, perhaps without the need for expensive biologic agents. A. Kaul. Rheumatology Advance Access. July 15, 2008. (Also see: Arthritis and Immunosuppressants) |
| Low-dose Prednisolone in Rheumatoid Arthritis (RA): Adverse Effects (AE) of Various Disease Modifying Antirheumatic Drugs (DMARD). Low-dose glucocorticoids retard radiological progression of RA and exhibit a differential effect on survival of DMARD and degree of AE due to DMARD. J Rheumatol April 15 2008 (Also See: Rheumatoid Arthritis and Medications: steroids) |
| Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. In this large cohort of RA patients, the most heightened risk of serious infections was seen with the use of glucocorticoid agents and immunosuppressive DMARDs. Rheumatology. Volume 46, Number 7 Pp. 1157-1160. (Also see: RA) |
| Therapy with Immunosuppressive Drugs and Biological Agents and Use of Contraception in Patients with Rheumatic Disease. The increasing use of combination therapies containing Methotrexate necessitates ensuring that advice regarding birth control is followed in order to avoid pregnancies exposed to potentially fetotoxic drugs. J Rheumatol 2007 June;34:1266-9. (Also see: Scleroderma and Pregnancy) |
| Biologic Agents |
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| Overview of Biologic Agents |
| Biologics 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). |
| 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. |
| 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. |
| Biologics: Target specific treatment of systemic and cutaneous autoimmune diseases. Consensus needs be formed to further categorize the clinical profiles of the patients in whom biologics are to be used in the future, given that the long-term safety profiles of these agents are very much unknown at present. Siba P Raychaudhuri. Indian Journal of Dermatology. 3 Jul 2009. (Also see: Autoimmunity) |
| Who Receives Biologics For Treatment Of RA? In multivariable comparisons of biologic users versus a subgroup of patients predominantly managed with steroids, biologic use was associated with younger age, lower baseline pain level, shorter disease duration, and less co-morbidity. Esi Morgan DeWitt. 74/74. ACR 2007. (Also see: RA) |
| Pregnancy Outcome after Exposure to Biologics: Results from the German Biologics Register RABBIT. Even though the numbers of cases are still low and final conclusions cannot be drawn, our data support the current view that exposure to biologic agents until confirmation of pregnancy does not increase the risk for congenital malformations, miscarriages or low birth weight. Anja Strangfeld. 730. ACR 2007. (Also see: Pregnancy) |
| 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) |
| Can Tumor Necrosis Factor (TNF) Inhibitors Be Safely Used in Pregnancy? If the activity or disease severity precludes the cessation of a TNF inhibitor and/or DMARD, uncontrolled observations suggest that conception and early pregnancy are not adversely affected by use of TNF inhibitors. Nearly 70% of pregnant patients can discontinue their TNF inhibitor early in the pregnancy (or with determination of pregnancy) without augmenting maternal or fetal risks. Yaser M. Ali J. Rheum. December 15, 2009. (Also see: Medications and Pregnancy) |
| TNF Inhibitors Do Not Raise Cancer Risk. Data on the first 6 years of anti-TNF therapy in routine care of rheumatoid arthritis (RA) patients show no increase in cancer risk, and this safety level was maintained throughout continued follow-upt. Janis C. Kelly. MSK Report November 12, 2009. |
| Follow-up results of 702 patients receiving tumor necrosis factor-alpha antagonists and evaluation of risk of tuberculosis (TB). The risk of development of active TB is increased in this group of patients despite chemoprophylaxis, but this risk remains within the acceptable limits even in a moderate-tuberculosis incidence country, if proper chemoprophylaxis regimen is adhered. Tulin Cagatay. Rheumatology International. October 21, 2009. |
| Lymphoma in patients treated with anti-TNF. Results of the 3-year prospective French RATIO registry. The two to threefold increased risk of lymphoma in patients receiving anti-TNF therapy is similar as that expected for such patients with severe inflammatory diseases. However, some lymphomas associated with immunosuppression may occur, and the risk of lymphoma is higher with monoclonal-antibody therapy than with soluble-receptor therapy. X Mariette. Ann Rheum Dis. 14 October 2009. (Also see: Cancer and Scleroderma) |
| Arthritis drugs raise cancer risk in kids-US FDA. The Food and Drug Administration, which urged greater caution with so-called TNF blockers last September, said an analysis of 48 reported cancer cases in children using the drugs "showed an increased risk of cancer, occurring after 30 months of treatment on average." Reuters. 08/04/09. (Also see: FDA Warnings) |
| Clinical Remission in Patients with Systemic Juvenile Idiopathic Arthritis (JIA) Treated with Anti-Tumor Necrosis Factor (TNF) Agents. Twenty-four percent of patients with systemic JIA experienced remission with anti-TNF therapy, but only 13% experienced sustained benefit. Ricardo A.G. Russo. J Rheum. March 30, 2009. (Also see: Juvenile Idiopathic Arthritis) |
| Autoimmune diseases induced by TNF-targeted therapies. The use of anti-TNF agents has been associated with an increasing number of cases of autoimmune diseases, principally cutaneous vasculitis, lupus-like syndrome, systemic lupus erythematosus and interstitial lung disease. (ScienceDirect) Manuel-Ramos Casels, MD. Best Practice & Research Clinical Rheumatology. October 2008. (Also see: Causes of Autoimmunity) |
| Cost-Effectiveness of Abatacept in Patients with Moderately to Severely Active Rheumatoid Arthritis (RA) and Inadequate Response to Tumor Necrosis Factor-α Antagonists (anti-TNF). Abatacept is cost-effective by current standards of medical practice in patients with moderately to severely active RA and inadequate response to an anti-TNF. Montserrat Vera-Llonch. J Rheumatol July 15 2008. (Also see: Rheumatoid Arthritis) |
| Influenza vaccine response impaired by anti-TNF treatment. Anti-tumor necrosis factor (TNF) alpha treatment modestly impairs the antibody response to influenza vaccination, but allows most patients to achieve a protective titer. The Job Cure (Reuters) 05/21/08. (Also see: Flu and Pneumonia Shots) |
| Exogenous tumor necrosis factor - alpha induces suppression of autoimmune arthritis. The role of endogenous TNF-alpha in the induction and propagation of arthritis is well established. However, exogenous TNF-alpha can downmodulate the course of AA, displaying an immunoregulatory functional attribute of this cytokine. Arthritis Research & Therapy 2008, 10:R38. April 1, 2008. (Also See: Arthritis) |
| Heart failure among younger rheumatoid arthritis (RA) and Crohn's (CD) patients exposed to TNF-{alpha} antagonists. We found only a small number of presumed HF cases in a large population of relatively young RA and CD patients. Rheumatology 2007 46(11):1688-1693. (Also see: RA, and Crohn's Disease) |
| 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. |
| 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) |
| Efficacy and Safety of Etanercept (Enbrel) in the Treatment of Scleroderma-Associated Joint Disease. This case series demonstrates that etanercept appeared to be efficacious in improving active inflammatory joint disease in a subset of scleroderma patients, and it was generally safe and well tolerated. J Rheumatol 2007 July;34:1636. Letter to the Editor. (Also see: Scleroderma Skeletal Involvement) |
| 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. |
| Fertility and Reproduction in Male Patients with Ankylosing Spondylitis (AS) Treated with Infliximab. We identified 4 patients with AS who had fathered 6 healthy children during infliximab treatment. Our cases provide some evidence or reassurance for male patients treated with the anti-tumor necrosis factor-α agent. S. Paschou. J Rheumatol First Release. Dec 1 2008. (Also see: Ankylosing Spondylitis and Male Infertility) |
| 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) |
| Refractory Vertebral Sarcoidosis Responding to Infliximab. We report a case of sarcoidosis, involving the lung and vertebrae, which was refractory to conventional therapy. Our patient's clinical symptoms and radiologic lesions of vertebral sarcoid dramatically improved after treatment with infliximab. Garg, Sanjay MD. Journal of Clinical Rheumatology. August 2008. (Also see: Sarcoidosis) |
| Rituximab (Rituxan) |
| Rituxan (Targeted B-cell Therapy). Indications and Uses. FDA Warning. Rituxan.com. |
| 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. |
| Rituximab for Scleroderma: Does Something Finally Work? The authors conclude that rituximab may improve lung function and skin scores in patients with scleroderma, and they propose larger randomized studies to investigate further the role of rituximab in treatment of scleroderma. Daoussis D. (Medscape Today). Rheumatology (Oxford). 2010;49:271-280. |
| 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. |
| Rituximab in diffuse cutaneous systemic sclerosis (dc-SSc): an open-label clinical and histopathological study. Rituximab appears to be well-tolerated and may have potential efficacy for skin disease in dc-SSc. V P Smith. Annals of Rheumatic Diseases. 22 December 2008. (Also See: Clinical Trials) |
| Antimalarials (Plaquenil, Hydroxychloroquine) |
| Plaquenil (Hydroxychloroquine). Hydroxychloroquine is classified as an anti-malarial drug. It is similar to chloroquine (Aralen) and is useful in treating several forms of malaria as well as lupus erythematosus and rheumatoid arthritis. MedicineNet.com. |
| Hydroxychloroquine for Rheumatoid Arthritis, Lupus Linked to Retinopathy. In patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE), long-term hydroxychloroquine therapy increases the risk of retinopathy, according to a February 12th online publication in Arthritis Care & Research. David Douglas. Medscape Today. (Reuters) 03/04/10. (Also see: RA and Lupus) |
| Systematic review of hydroxychloroquine (Plaquenil) use in pregnant patients with autoimmune diseases. The purpose of this study was to compare the incidence of congenital defects, spontaneous abortions, number of live births, fetal death and pre-maturity in women with autoimmune diseases taking HCQ during pregnancy. It found that HCQ is not associated with any increased risk of congenital defects, spontaneous abortions, fetal death, pre-maturity and decreased numbers of live births in patients with auto-immune diseases. Kirk Sperber Pediatric Rheumatology 13 May 2009. (Also see: Pregnancy and Medications) |
| Medicinal Metals: Gold, Platinum |
| Gold and some other metals have been proven to suppress the inflammatory process. DMARDs such as Auranofin and Gold sodium thiomalate are forms of gold used to treat rheumatic diseases such as rheumatoid arthritis. |
| Gold Preparations (Ridaura, Myochrysine, Solganol). Patient Information. American College of Rheumatology. |
| Mystery solved: Gold's power against autoimmune diseases defined. Gold compounds have been used for the treatment of rheumatoid arthritis and other autoimmune diseases for more than 75 years, but until now, how the metals work has been a mystery. Harvard Medical School researchers report that special forms of gold, platinum, and other classes of medicinal metals work by stripping bacteria and virus particles from the grasp of a key immune system protein. It may now be possible to develop a new generation of gold-based drugs for treating autoimmune diseases that are more effective with fewer side effects. EurekAlert! 02-26-06. |
| Sulfasalazine |
| Sulfasalazine (Azulfidine) is an anti-inflammatory medication that belongs to a class of drugs called sulfa drugs. Sulfasalazine is also known as a disease modifying antirheumatic drug (DMARD) because it not only decreases the pain and swelling of arthritis but also may prevent damage to joints and reduce the risk of long term disability. Patient Information. American College of Rheumatology. |
