Categories of scientific evidence for off-label indication
When the evidence of off-label use
of tocilizumab in a specific indication is approved in foreign
countries, that is classified as category I. If the indication is
recommended by Up To Date/ Micromedex (I/IIa/IIb) or authoritative
society guideline, that is classified as category II. When the
indication is supported by systematic review, RCT, cohort study,
non-randomized controlled study, expert consensus, that is classifed as
category III. If the indication is supported by case series report or
case report, that is classified as category IV. The category V is the
indication without medical evidences support.