Eligibility criteria for bDMARD/tsDMARD in rheumatoid arthritis (RA) are defined by NICE MTA 375 technology appraisal endorsed by HIS and subsequent SMC advice as summarised below:
Biologic agents included in Table 1, all in combination with methotrexate, are options for treating rheumatoid arthritis, only if:
- disease is severe, that is, a disease activity score (DAS28) greater than 5.1 and
- disease has not responded to intensive therapy with a combination of conventional diseasemodifying anti-rheumatic drugs (csDMARDs): i.e. at least two csDMARDs including methotrexate (unless contraindicated)
- Adalimumab, etanercept, certolizumab pegol, tocilizumab & tsDMARDS can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria above are met. Off- label monotherapy for other biologics may be appropriate in some clinical circumstances.
- Rituximab is suitable as a second line biologic drug in specific clinical scenarios provided the above criteria are met.
- tsDMARD (JAK inhibitors) can be used based on the above criteria as an alternative to first line biologic treatment or as second line treatment where patients are ineligible for rituximab (SMC) or where the clinician anticipates better clinical response over other MOA’s