Off-label use judgement
The standard of evaluating whether the use of tocilizumab is off-label
or on-label is based on current drug label (Roche Pharma (Schweiz)
Ltd.), which is approved by the National Medical Products Administration
(NMPA) in 1st January, 2018. The legally approved indications of
tocilizumab are RA and sJIA up to now. The recommended dosage for the
treatment of RA is 8mg/kg and administrate every four weeks
intravenously while for sJIA is 12mg/kg (weight great than or equal to
30kg) and 8mg/kg (weight less than 30kg) every two weeks, intravenously.
Basically, there is no obvious difference of recommended dosage of
tocilizumab between China and foreign countries due to the dosage is
generally based on patients’ body weight. As such, the dosage did not
take account into the off-label use of tocilizumab in this study. We put
more emphasis on the off-label use of tocilizumab in terms of
indication. The criteria of off-label prescriptions involved is if the
doctor prescribed tocilizumab for treating other indications rather RA
and sJIA, and that prescription considered as off-label one.