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. Author manuscript; available in PMC: 2014 Nov 1.
Published in final edited form as: Clin Ther. 2013 Oct 22;35(11):1850–61.e1. doi: 10.1016/j.clinthera.2013.09.015

Table 1.

Published randomized trials and observational studies that discontinued anti-TNFs for RA patients in either low disease activity or remission

Trial name (Reference) and number of patients who discontinued anti-TNF therapy Study design Disease activity criteria for discontinuation of anti-TNF therapy Minimum Duration of LDA or remission prior to anti-TNF discontinuation Study duration following anti-TNF discontinuation Anti-TNF discontinued % of patients in remission or LDA after anti-TNF discontinuation Duration of remission/LDA off anti-TNF
Quinn 15 (N = 10) Randomized trial/double blind None† N/A† 12 months Infliximab 70%*** N/A
BeSt 17 (N = 104)* Randomized trial/single blind DAS 44 ≤ 2.4 6 months ¥ Infliximab 24%*** Median = 17 months (IQR 3−47)
Smolen 21 (N =197) Randomized trial/blinded DAS28 (ESR) ≤ 3.2 1 visit& 12 months Etanercept 43%*** N/A
HIT HARD 22 (N = 82) Randomized trial/blinded None† N/A† 6 months Adalimumab N/A†† N/A
Nawata 23 (N = 9) Observational study/prospective DAS28 (ESR) < 2.6 6 months ¥ Infliximab 5% Mean = 14.2 months
Brocq 24 (N = 21) Observational study/prospective DAS28 (ESR) < 2.6 6 months ¥ Infliximab, etanercept or adalimumab 25%** Mean = 14.7 weeks
Tanaka 25 (N = 102) Observational study/prospective DAS28 (ESR) < 3.2 6 months 12 months Infliximab 55%** N/A
Van der Maas 26 (N = 51) Observational study/prospective DAS28 (ESR) < 3.2 6 months 12 months Infliximab 16 %*** N/A
Harigai 27 (N = 22) Observational study/retrospecti ve DAS28(CRP) < 2.7 1 time 12 months Adalimumab 18%*** N/A
OPTIMA29 (N =207) Randomized trial/blinded DAS (ESR) < 3.2 2 visits (1 month apart) 12 months Adalimumab 81%** N/A
†

All patients discontinued anti-TNF after 6 months regardless of disease activity.

††

Outcome measured as sustained effect after 6 months adalimumab discontinuation.

Time to flare outcome.

&

This included a period of 24 weeks with DAS28 ≤ 3.2 and at week 36 of the open label study.

¥

Follow up time varied.

*

Number of patients that met criteria for infliximab discontinuation in the 5 years of follow up and that were subsequently tapered off.

**

Remission or LDA at the end of observation time.

***

Patients that had persistent LDA and did not required anti-TNF retreatment during observation time.