Biologics for RA Do Not Provide Long-Term Treatment Solution, Says Study

An analysis of 6209 patients drawn from the Consortium of Rheumatology Researchers of North America found that nearly half of patients discontinue treatment with biologics within 2 years.

An analysis of 6209 patients drawn from the Consortium of Rheumatology Researchers of North America found that nearly half of patients discontinue treatment with biologics within 2 years.

Nearly 50% of patients taking biologic treatments for rheumatoid arthritis (RA) abandon these therapies within 2 years of starting them, according to research presented this month at the annual meeting of the European League Against Rheumatism (EULAR).

Researchers enrolled 6209 patients who started treatment for RA with large-molecule therapies between 2002 and 2011 and had at least 6 months of follow-up data. Forty-three percent of these patients had never used a biologic therapy prior to enrollment in the study. Before starting treatment with biologics, one-third of these patients were being treated with prednisone, and nearly two-thirds with methotrexate.

Patient adherence was surveyed at 6 months, 1 year, and 2 years after starting treatment with biologics. Patients being treated with both tumor necrosis factor inhibitor therapies (TNF) and non-TNF biologics were found to have increasing medication discontinuation rates over time: At 6 months, 1 year, and 2 years, 83%, 68%, and 52% of patients on TNF inhibitors were still on treatment, respectively. Similarly, 81%, 63%, and 46%, of patients on non-TNF agents were still adherent at these points.

The reasons for stopping treatment most commonly cited by study participants were loss of efficacy (35.8%), safety concerns and adverse events (20.1%), physician preference (27.8%), and patient preference (17.9%). Loss of efficacy appeared to be of greater concern for the non-TNF group (44.2% versus 34.2% for those taking TNF therapies), whereas safety issues were the top reason for nonadherence in the TNF treatment group (20.8% versus 16.8% for those taking non-TNF therapies).

On average, patients taking TNF medications continued their treatment nearly 6 months longer than those taking non-TNF therapies. This may indicate that, despite the high overall rate of biologic treatment discontinuation across all patients in the study, TNF therapies had more staying power over the time period studied. Historically, TNF inhibitors have been associated with better treatment retention and durability than non-TNF therapies, but this may be due to the fact that there are 5 TNF agents available, compared with only 3 non-TNF treatments, lead study author Vibeke Strand, MD, adjunct clinical professor in the division of immunology/rheumatology at Stanford University School of Medicine, told MedPage Today.

Dr. Strand added that even though there are many treatment options for RA, few criteria exist for accessing RA therapies other than failure on a traditional disease-modifying anti-rheumatic drug.

“None of these therapies work for all patients, and none of them are cures,” Dr. Strand told MedPage Today. “When patients initiate treatment with a biologic, there are often fairly high expectations, some of which may not be met. I think what this really says is that there’s not sufficient satisfaction with treatment.”

Although the research was presented in Europe, the data were drawn from a pool of subjects in the United States, which “is associated with a significantly greater prevalence of biologic utilization than is typically seen elsewhere,” Dr. Strand noted in a EULAR press release. "The results may, therefore, be different in societies with less prevalent utilization of these agents."

When asked if it would be difficult to develop a clinical pathway for RA considering there are so many treatment options, Dr. Strand told Specialty Pharmacy Times, "We've been trying for a long time to develop assays that will predict which therapeutic pathway will be more effective in individual patients. So far, we aren't there."