June 3, 2008 To manage the painful and incapacitating symptoms of rheumatoid arthritis (RA), a chronic, inflammatory joint disease, the majority of patients rely on disease-modifying antirheumatic drugs (DMARDs). In addition to trusted nonbiologic DMARDs, a number of biologic agents now promise to improve treatment for RA. The American College of Rheumatology (ACR) has not updated recommendations for non-biologic DMARDs since 2002 and has not previously developed recommendations for biologic agents. In view of that, ACR decided it was time for a major re-evaluation of the use of DMARD therapy in rheumatoid arthritis.
Under the guidance of a Core Expert Panel of clinicians and methodologists and based on a systematic review of the scientific evidence, a second group of internationally recognized clinicians, methodologists, and patient representatives with extensive expertise in the use of nonbiologic and biologic DMARDs developed these recommendations for the ACR. These recommendations on the use of non-biologic and biologic DMARDs in RA address 5 key areas pre-specified by the ACR: indications for use, monitoring for side-effects, assessing the clinical response, screening for tuberculosis (a risk factor associated with biologic DMARDs), and under certain circumstances (i.e. high disease activity) the roles of cost and patient preference in choosing biologic agents. When developing these recommendations, RA disease duration, disease severity, and prognostic features were also considered.
“These recommendations were developed for specialist clinicians familiar with assessing RA disease activity and disease severity,” notes Kenneth Saag, M.D., Professor of Medicine and Epidemiology at The University of Alabama at Birmingham, who co-led the project . “Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision-making. The recommendations developed are not intended to be used in a ‘cookbook’ or prescriptive manner or to limit a physician’s clinical judgment, but rather to provide guidance based on clinical evidence and expert panel input.”
The ACR 2008 recommendations for nonbiologic and biologic DMARD use in RA include:
- Initiating methotrexate or leflunomide therapy was recommended for most RA patients.
- Methotrexate plus hydroxychloroquine was endorsed for patients with moderate to high disease activity.
- The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine for patients with poor prognostic features and moderate to high levels of disease activity.
- Prescribing anti-TNFα agents—etanercept, infliximab, or adalimumab—along with methotrexate in early RA (less than 3 months) only for patients with high disease activity who had never received DMARDs. In intermediate- and longer-duration RA, anti-TNFα agents were recommended for patients who had failed to respond adequately to methotrexate therapy.
- Reserving the fusion protein abatacept and the B-cell antibody(rituximab) for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other nonbiologic DMARDs led to an inadequate response.
- Avoiding the initiation or resumption of treatment with methotrexate, leflunomide, or biologic agents for patients with active bacterial infection, active herpes-zoster viral infection, active or latent tuberculosis, or acute or chronic hepatitis B or C.
- Not prescribing anti-TNFα agents to patients with a history of heart failure, with a history of lymphoma, or with multiple sclerosis or demyelinating disorders.
- Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.
“These recommendations are extensive but not comprehensive,” Dr. Saag acknowledges, “and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology.”
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- Kenneth G. Saag, Gim Gee Teng, Nivedita M. Patkar, Jeremy Anuntiyo, Catherine Finney, Jeffrey R. Curtis, Harold E. Paulus, Amy Mudano, Maria Pisu, Mary Elkins-Melton, Ryan Outman, Jeroan J. Allison, Maria Suarez Almazor, S. Louis Bridges, Jr., W. Winn Chatham, Marc Hochberg, Catherine Maclean, Ted Mikuls, Larry W. Moreland, James O%u2019Dell, Anthony M. Turkiewicz, and Daniel E. Furst. American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis Care & Research, June 15, 2008; 59:6, pp. 762-784
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