TY - JOUR
T1 - Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate
T2 - 52-week results from a prospective, randomised, controlled study (SURPRISE study)
AU - Kaneko, Yuko
AU - Atsumi, Tatsuya
AU - Tanaka, Yoshiya
AU - Inoo, Masayuki
AU - Kobayashi-Haraoka, Hitomi
AU - Amano, Koichi
AU - Miyata, Masayuki
AU - Murakawa, Yohko
AU - Yasuoka, Hidekata
AU - Hirata, Shintaro
AU - Nagasawa, Hayato
AU - Tanaka, Eiichi
AU - Miyasaka, Nobuyuki
AU - Yamanaka, Hisashi
AU - Yamamoto, Kazuhiko
AU - Takeuchi, Tsutomu
N1 - Publisher Copyright:
© 2016 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Objective To compare the efficacy and safety between tocilizumab added to methotrexate and tocilizumab switched from methotrexate in patients with active rheumatoid arthritis (RA). Methods This is a 2-year randomised, controlled study. RA patients with moderate or high disease activity despite methotrexate were randomly assigned either to tocilizumab added to methotrexate (add-on) or tocilizumab switched from methotrexate (switch). The primary endpoint was the DAS28 remission rate at week 24. Secondary objectives included other clinical efficacy indices, radiological outcomes assessed with the van der Heijde-modified total Sharp scoring system (mTSS), and safety. Results Of 223 randomised patients, 83% completed 52â €..weeks. DAS28 remission rates at week 24 were 70% for add-on and 55% for switch (p=0.02), but they became comparable at week 52 (72% vs 70%, p=0.86). Structural remission rates (mTSS≤0.5) at week 52 were not different (66% vs 64%, p=0.92). However, clinically relevant radiographic progression rates (CRRP; mTSS≥3) tended to be higher with the switch than with the add-on (15% vs 7%, p=0.07). Radiographic progression in the CRRP patients was larger with the switch than with the add-on (9.0/year vs 5.0/year, p=0.04). The difference in the mean C-reactive protein of the CRRP patients was significant for the first 24â €..weeks (1.56 vs 0.49, p=0.001) but not for the following 28â €..weeks (0.10 vs 0.04, p=0.1). Overall safety was preferable in the switch group. Conclusions In RA patients with inadequate response to methotrexate, tocilizumab added to methotrexate more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical efficacy and prevention of joint destruction. Trial registration number NCT01120366.
AB - Objective To compare the efficacy and safety between tocilizumab added to methotrexate and tocilizumab switched from methotrexate in patients with active rheumatoid arthritis (RA). Methods This is a 2-year randomised, controlled study. RA patients with moderate or high disease activity despite methotrexate were randomly assigned either to tocilizumab added to methotrexate (add-on) or tocilizumab switched from methotrexate (switch). The primary endpoint was the DAS28 remission rate at week 24. Secondary objectives included other clinical efficacy indices, radiological outcomes assessed with the van der Heijde-modified total Sharp scoring system (mTSS), and safety. Results Of 223 randomised patients, 83% completed 52â €..weeks. DAS28 remission rates at week 24 were 70% for add-on and 55% for switch (p=0.02), but they became comparable at week 52 (72% vs 70%, p=0.86). Structural remission rates (mTSS≤0.5) at week 52 were not different (66% vs 64%, p=0.92). However, clinically relevant radiographic progression rates (CRRP; mTSS≥3) tended to be higher with the switch than with the add-on (15% vs 7%, p=0.07). Radiographic progression in the CRRP patients was larger with the switch than with the add-on (9.0/year vs 5.0/year, p=0.04). The difference in the mean C-reactive protein of the CRRP patients was significant for the first 24â €..weeks (1.56 vs 0.49, p=0.001) but not for the following 28â €..weeks (0.10 vs 0.04, p=0.1). Overall safety was preferable in the switch group. Conclusions In RA patients with inadequate response to methotrexate, tocilizumab added to methotrexate more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical efficacy and prevention of joint destruction. Trial registration number NCT01120366.
KW - DMARDs (biologic)
KW - Disease Activity
KW - Rheumatoid Arthritis
KW - Treatment
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U2 - 10.1136/annrheumdis-2015-208426
DO - 10.1136/annrheumdis-2015-208426
M3 - Article
C2 - 26733110
AN - SCOPUS:84956630876
SN - 0003-4967
VL - 75
SP - 1917
EP - 1923
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 11
ER -