BIRMINGHAM, Alabama—For the first time since 2002, the American College of Rheumatology (ACR) updated its recommendations for the use of traditional disease-modifying antirheumatic drugs (DMARDs) as well as added recommendations for using biologic agents to treat rheumatoid arthritis (RA). The new guidelines appear in the June 2008 issue of Arthritis Care & Research.1

"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."—Kenneth Saag, MD
The guidelines comprise recommendations on indications for use, monitoring for side-effects, assessing the clinical response, screening for tuberculosis, and the roles of cost and patient preference in choosing biologic agents. RA disease duration, severity, and prognostic features were also considered when developing the new guidelines.

A guide, not a cookbook

"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,” said guideline author Kenneth Saag, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham. “These recommendations are extensive but not comprehensive, 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.”

Highlights of the new recommendations include the following:
  • Initiating methotrexate (MTX) or leflunomide therapy for most RA patients
  • Using MTX plus hydroxychloroquine in RA patients with moderate to high disease activity
  • Using the triple DMARD combination of MTX plus hydroxychloroquine plus sulfasalazine in patients with poor prognostic features and moderate to high levels of disease activity
  • Prescribing anti-TNF agents—etanercept, infliximab, or adalimumab—along with MTX in early RA (<3 months) only for patients with high disease activity who had never received DMARDs
  • Prescribing anti-TNF agents in intermediate- and longer-duration RA only in patients who had failed to respond adequately to MTX therapy
  • Prescribing abatacept and rituximab only for patients with at least moderate disease activity and poor disease prognosis for whom MTX in combination with or sequential administration with other nonbiologic DMARDs led to an inadequate response
  • Avoiding the initiation or resumption of treatment with MTX, 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-TNF agents to patients with a history of heart failure, lymphoma, multiple sclerosis, or demyelinating disorders
  • Avoiding the initiation or resumption of MTX, leflunomide, or minocycline in RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding

The new guidelines were created via a systematic literature review by a working group and core expert panel of doctors and methodologists. A task force of clinicians, methodologists, and informed patient representatives then critiqued and rated the proposed guidelines using the modified Research and Development/University of California at Los Angeles Appropriateness Method.

Translating the new guidelines into practice

"The new guidelines emphasize that we should be carefully evaluating patients ahead of time and reiterate the need for monitoring our patients," said Joseph I. Cohn, MD, rheumatologist at Mercy Medical Center in Rockville Centre, NY.

The new guidelines also help answer questions concerning cancer and infection risk as well as whether there are intrinsic differences among available drugs, he told MSKreport.com.

"The biologic drugs are not the wave of the future. The future is here and these drugs are better than what we were using, but there are concerns." That's why, "it's really important that we take a careful history to determine risks of infection and cancer, we monitor and follow patients and be sure of why we are using a certain drug," he said. "The guidelines should help us do that."

Reference

1. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Care Res. 2008;59:762-784.