Table 3

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 assessmentSwitch based on 6-month assessmentChange of frequency/dose
Criteria*N (%)CountriesCriteria*N (%)CountriesCriteriaN (%)Countries
Not specified22 (61%)AL, AT, BG, CZ, DK, FI, FR, DE, IS, IE, IT, LV, LU, MK, ME, NO, RO, RS, SK, ES, SE and CHNot specified17 (47%)AL, BE, BG, HR, DK, FI, FR, DE, IE, IT, LU, MK, MT, NO, SL, CH and TRNot specified18 (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≥3.25 (14%)CY, MT, HR, HU and BEYes, in terms of disease activity level 11 (31%)DAS28≥3.26 (17%)CY, GR, IS, LV, ES and SEYes, 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>5.11 (3%)ROYes, dose18 (50%)CY, CZ, DK, GR, IS, IE, IT, LT, MT, NO, RO, RS, SK, SL, ES, CH, TR and HU
Moderate disease activity3 (8%)AT, CZ and SK
Yes, in terms of DAS28 improvement 14 (39%)Δ <0.61 (3%)BEYes, in terms of DAS28 improvement10 (28%)Δ<0.6 in 3 months1 (3%)PT
Δ <1.214 (39%)BE‡, HR, CY, EE, GR, HU, MT, NL, PT, SL, TR, UK, LT§ and PL§Δ<1.210(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.