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The time has come to limit the placebo period in rheumatoid arthritis trials to 3 months: A systematic comparison of 3- and 6-month response rates in trials of biologic agents.
Annals of Rheumatic Diseases, 10/08/09

Boers M et al. – The placebo phase of registration trials for RA can be limited to 3 months. An accompanying viewpoint proposes to then switch placebo patients to standard of care, allowing a more valid and comprehensive assessment including safety.

Methods

Meta-analysis of placebo- or active control trials of biologic agents in DMARD-IR RA, comparing the contrast in ACR response between experimental and control groups at 3 and 6 months

Results

20 trials yielded 15 placebo and 18 active control contrasts (>10,000 patients)
At 3 months active treatment showed highly significant contrast with placebo for ACR20 and -50 in every instance
As all groups improved further the mean contrast at 6 months was unchanged
For ACR70 contrast was clearly greater at 6 months due to further improvement only in experimental groups
In active control trials contrasts were smaller, for ACR50 and-70 these decreased somewhat due to 'catch-up' responses in control groups

Exclusive Author Commentary
Maarten Boers, 11/03/09

In the print edition hopefully appearing soon, I've outlined a new trial design that encorporates the above findings: patients in the placebo group are mandatorily switched to standard of care (usually anti-TNF) after 3 months. This allows secondary head-to-head comparisons. Please note that I'm NOT advocating that the total trial duration should be limitied to 3 months.

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