For how we live.
A 9 October labelling supplement folds results from two post-marketing rheumatoid-arthritis safety studies into the JAK inhibitor baricitinib's boxed warning, and revises its infection and cardiovascular sections.
In a 348-patient trial, patients in sustained low disease activity who stepped down their biologic kept it almost as often as those who stayed on full dose over 24 weeks — but some measures still favoured continuing.
AMPLIFIED enriched for early rheumatoid arthritis patients thought to respond best to abatacept, then compared it head-to-head with adalimumab. At week 24 the two drugs were indistinguishable.
Two blinded randomised trials found magnetic wrist straps and copper bracelets worked no better than dummy versions for arthritis pain. The reported relief looks like a placebo effect.
Analgesic trials keep failing, and one reason is that the comparison arm keeps improving. Where a trial recruits, how long it runs and how big it is all move the placebo response — and none of that is about the drug.
The FDA's approval bar requires no clinically meaningful difference from the original, and a large switching trial found no loss of control. The savings gap is a market problem, not a safety one.
Pain medicine added a third mechanistic category in 2017 and has been arguing about it since. There is no test for it, the criteria work by exclusion, and the experts who wrote them say that is a problem.