Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate: 52-week results from a prospective, randomised, controlled study (SURPRISE study)

Yuko Kaneko, Tatsuya Atsumi, Yoshiya Tanaka, Masayuki Inoo, Hitomi Kobayashi-Haraoka, Koichi Amano, Masayuki Miyata, Yohko Murakawa, Hidekata Yasuoka, Shintaro Hirata, Hayato Nagasawa, Eiichi Tanaka, Nobuyuki Miyasaka, Hisashi Yamanaka, Kazuhiko Yamamoto, Tsutomu Takeuchi

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Abstract

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 52 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 24 weeks (1.56 vs 0.49, p = 0.001) but not for the following 28 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.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
DOIs
Publication statusAccepted/In press - 2016 Jan 5

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Methotrexate
Rheumatoid Arthritis
Switches
Safety
tocilizumab
C-Reactive Protein
Joints
Inflammation

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate : 52-week results from a prospective, randomised, controlled study (SURPRISE study). / Kaneko, Yuko; Atsumi, Tatsuya; Tanaka, Yoshiya; Inoo, Masayuki; Kobayashi-Haraoka, Hitomi; Amano, Koichi; Miyata, Masayuki; Murakawa, Yohko; Yasuoka, Hidekata; Hirata, Shintaro; Nagasawa, Hayato; Tanaka, Eiichi; Miyasaka, Nobuyuki; Yamanaka, Hisashi; Yamamoto, Kazuhiko; Takeuchi, Tsutomu.

In: Annals of the Rheumatic Diseases, 05.01.2016.

Research output: Contribution to journalArticle

Kaneko, Yuko ; Atsumi, Tatsuya ; Tanaka, Yoshiya ; Inoo, Masayuki ; Kobayashi-Haraoka, Hitomi ; Amano, Koichi ; Miyata, Masayuki ; Murakawa, Yohko ; Yasuoka, Hidekata ; Hirata, Shintaro ; Nagasawa, Hayato ; Tanaka, Eiichi ; Miyasaka, Nobuyuki ; Yamanaka, Hisashi ; Yamamoto, Kazuhiko ; Takeuchi, Tsutomu. / Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate : 52-week results from a prospective, randomised, controlled study (SURPRISE study). In: Annals of the Rheumatic Diseases. 2016.
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abstract = "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 52 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 24 weeks (1.56 vs 0.49, p = 0.001) but not for the following 28 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.",
author = "Yuko Kaneko and Tatsuya Atsumi and Yoshiya Tanaka and Masayuki Inoo and Hitomi Kobayashi-Haraoka and Koichi Amano and Masayuki Miyata and Yohko Murakawa and Hidekata Yasuoka and Shintaro Hirata and Hayato Nagasawa and Eiichi Tanaka and Nobuyuki Miyasaka and Hisashi Yamanaka and Kazuhiko Yamamoto and Tsutomu Takeuchi",
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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

PY - 2016/1/5

Y1 - 2016/1/5

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 52 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 24 weeks (1.56 vs 0.49, p = 0.001) but not for the following 28 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 52 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 24 weeks (1.56 vs 0.49, p = 0.001) but not for the following 28 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.

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