Summary of clinical eligibility criteria for stop of the therapy, switch to another bDMARD or change frequency/dose of a biologic for European countries with at least one biologic reimbursed (n=36)
| Stop due to inefficacy based on 6 -month assessment | Switch based on 6-month assessment | Change of frequency/dose | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Criteria* | N (%) | Countries | Criteria* | N (%) | Countries | Criteria | N (%) | Countries | ||
| Not specified | 22 (61%) | AL, AT, BG, CZ, DK, FI, FR, DE, IS, IE, IT, LV, LU, MK, ME, NO, RO, RS, SK, ES, SE and CH | Not specified | 17 (47%) | AL, BE, BG, HR, DK, FI, FR, DE, IE, IT, LU, MK, MT, NO, SL, CH and TR | Not specified | 18 (50%) | AL, AT, BE, BG, HR, EE, FI, FR, DE, LV, LU, ME, NL, PL, PT, SE, UK and MK | ||
| Yes, in terms of disease activity level 7 (19%) | DAS28≥3.2 | 5 (14%) | CY, MT, HR, HU and BE | Yes, in terms of disease activity level 11 (31%) | DAS28≥3.2 | 6 (17%) | CY, GR, IS, LV, ES and SE | Yes, frequency | 15 (42%) | CY, CZ, DK, GR, IS, IE, IT, MT, NO, RO, RS, SL, ES, CH and TR |
| DAS28>4.6 † | 1 (3%) | EE | ||||||||
| DAS28>5.1 | 1 (3%) | RO | Yes, dose | 18 (50%) | CY, CZ, DK, GR, IS, IE, IT, LT, MT, NO, RO, RS, SK, SL, ES, CH, TR and HU | |||||
| Moderate disease activity | 3 (8%) | AT, CZ and SK | ||||||||
| Yes, in terms of DAS28 improvement 14 (39%) | Δ <0.6 | 1 (3%) | BE | Yes, in terms of DAS28 improvement10 (28%) | Δ<0.6 in 3 months | 1 (3%) | PT | |||
| Δ <1.2 | 14 (39%) | BE‡, HR, CY, EE, GR, HU, MT, NL, PT, SL, TR, UK, LT§ and PL§ | Δ<1.2 | 10(28%) | CY, HU, LT§, ME, NL, PL§, PT, RO, RS and UK | |||||
*Countries could have more than one criterion to stop/switch (disease activity level and/or disease activity improvement).
†Additional clinical criteria have to be satisfied besides the specified level of DAS28, for example, additional requirement for radiographic damage or specific levels of swollen joint count and/or total joint count.
‡If DAS28>5.1.
§After 3 months.
bDMARD, biologic disease-modifying antirheumatic drugs; DAS28, disease activity score with 28-joint assessment.
AL, Albania; AT, Austria; BE, Belgium; BG, Bulgaria; CH, Switzerland; CY, Cyprus; CZ, Czech Republic; DE, Germany; DK, Denmark; EE, Estonia; ES, Spain; FI, Finland; FR, France; GR, Greece; HR, Croatia; HU, Hungary; IE, Ireland; IS, Iceland; IT, Italy; LT, Lithuania; LU, Luxemburg; LV, Latvia; ME, Montenegro; MK, Macedonia; MT, Malta; NL, the Netherlands; NO, Norway; PL, Poland; PT, Portugal; RO, Romania; RS, Serbia; SE, Sweden; SK, Slovakia; SL, Slovenia; TR, Turkey; UK, United Kingdom.