Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years

Table 2 Definition of protocol deviation

Dose escalation criteria fulfilled	Significant toxicity occurred ¹	Protocol deviation
Dose escalation criteria fulfilled	Significant toxicity occurred ¹	No	Yes
Yes	No	Intensified	Continued/tapered/discontinued
Yes	Yes	Intensified²	Continued/tapered/discontinued³
No	No	Continued	Intensified/tapered/discontinued
No	Yes	Continued/tapered/discontinued	Intensified
Yes/no	Yes/no		Discontinuation of all DMARDs⁴

¹Severe toxicities, according to physician’s assessment, deemed to be unfavourable to the health of the patient. Minor complaints were not considered as significant toxicity; ²when the existing drug was withdrawn or dose reduced due to toxicity but the dose of another drug was increased or a new agent was added, treatment was considered as intensified; ³if significant toxicity occurred; therapy escalation was not expected. However, it was considered a deviation as the disease was still active (that is, dose escalation criteria fulfilled); ⁴stopping all disease-modifying anti-rheumatic drugs (DMARDs) regardless of patient’s disease activity or toxicity status were considered deviation.

ISSN: 1478-6362