Why Switch Biologics? Inefficacy, But Other Reasons Too

EULAR 2013: Data from the multicenter CORONNA trial show that a third of patients switch biologics within a year. It also reveals the major reasons for switching.

After a year on biologic therapies – either a tumor necrosis factor inhibitor (TNFi) or a non-TNFi -- roughly one-third of RA patients in the US discontinue or switch biologics. Fully half either quit or change biologics after two years, mostly because of lack of effect, researchers reported at the 2013 annual meeting of the European League Against Rheumatism (EULAR) in Madrid, Spain.

Insights from 6,209 RA patients in the CORRONA (Consortium of Rheumatology Researchers of North America) Registry offer a snapshot of current practice in the use of biologics and the multitude of reasons patients or doctors change their minds. The expectations of both patients and physicians seem to play a role, said Vibeke Strand MD, a clinical professor and adjunct in the Division of Immunology/Rheumatology at Stanford University, a consultant to the registry.

Among the CORRONA patient cohort, nearly 80% of them women, almost half (43.4%) were biologic-nave at the start of the study, which spanned the years 2001 to 2011. The mean duration of disease was 8 years at baseline.

Around six months after starting therapy, 81% (n=5,010) were taking a TNFi rather than a non-TNFi.
Evidently less-ill patients are starting out on TNFi therapy: Compared to the 19% starting out on non-TNFi drugs, they had a shorter duration of disease, lower disease activity, and lower mHAQ pain and fatigue scores.

At six months, 82% of patients remained on their first treatment, but by one year that number had dropped to 67%. However, those begun on a TNFi were somewhat more likely to stay with it: The median time to discontinuation or change of therapy was  26.5 months for those on a TNFi but less than two years (20.5 months) for those taking a non-TNFi.

There was a slightly higher durability of treatment among the biologic-nave patients, but not enough to reach statistical significance.

The strongest reason for discontinuing a biologic, perhaps not surprisingly, was loss of efficacy. More than a third of patients (35.8%) cited this reason, but other concerns were safety (20%) and access to treatment (9%). However, the puzzling indicator "preference" was also a factor, more strongly for physicians (28%) than for patients (18%).

The reasons for the preference are not evident from the data. "The nature of a registry is that people check the box, but they don't explain," replied Dr. Strand when asked to elaborate. "I'd imagine the MD was unhappy with either safety or efficacy, but unless specified we do not know."

Simply having been on a biologic for more than a year was a strong predictor of switching, in multivariate analysis. Other strong predictors of discontinuation included higher Crohn's disease activity and mHAQ (modified health questionnaire) scores, as well as patient-reported anxiety or depression.

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