“We established a task force panel of international experts that then used a formal development process—the RAND/UCLA Appropriateness Method that has been used in the development of other formal clinical recommendations—to fill in the gaps since the last set of guidelines were published,” says Dr. Saag. “We focus heavily on biologics and where they fit into the treatment paradigm.” A total of 801 full-text articles were considered for review. These included 515 on nonbiologic agents, 226 on biologic DMARDs, and 60 on cost.
Establishing a safety and efficacy profile was a key goal of the guideline process, say its authors. “The two principles of our maximally inclusive search approach were to address indications and therapeutic response to nonbiologic DMARDs and biologic agents for RA, and to address the potential adverse events of nonbiologic and biologic DMARDs, including TB for biologic DMARDs,” say Drs. Saag and Furst.
Additional Areas of Recommendation
In addition to formally recommending the indications for starting or resuming nonbiologic or biologic DMARDs, the task force panel report also made recommendations in these areas:
- Contraindications to the use of nonbiologic and biologic DMARDs. These include contraindications for infectious disease and/or pneumonitis, hematologic and oncologic indications such as a white blood cell count below 3000 mm, liver indications including acute hepatitis B or C and chronic hepatitis B or C, renal indications such as a creatinine clearance less than 30 ml/minute, neurologic indication including multiple sclerosis or demyelinating disorders, pregnancy and breastfeeding, and perioperative infectious risk.
- Safety monitoring, risk surveillance, and preventive immunizations for patients on DMARDs. There are some safety concerns with some biologic DMARD. Early identification of any potential risk or adverse reaction should be the goal of routine laboratory testing. Vaccinations for flu are recommended for patients before they begin DMARD treatment. Hepatitis vaccination is recommended on an individual basis if there is an identified risk.
- TB screening for patients on biologic DMARDs. The goal is to identify any latent infection before starting a course of DMARD therapy.
Feedback and Continuing Review
The ACR’s Guidelines Subcommittee, Quality of Care Committee, and Board of Directors were asked to review the draft guidelines before publication and ACR’s general membership was likewise invited to offer feedback at the 2007 Annual Scientific Meeting. The published guidelines incorporate this feedback. “These guidelines are relatively robust evidence-based guidelines and offer solid evidence of practice for rheumatologists,” says Dr. Solomon. Some rheumatologists have questioned the usefulness of the new guidelines because they do not include all DMARDs currently used in practice. “The guidelines can be used as a reference if the physician has trouble knowing what is the best evidence-based treatment, but they fail to address a number of important questions,” says Joan Bathon, MD, professor of medicine at Johns Hopkins University School of Medicine in Baltimore, who co-authored an editorial that was published in the same issue of Arthritis Care & Research with the guidelines.2
