Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: Results from a prospective randomised controlled study (the second year of the SURPRISE study)

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

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: To evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate. Methods: The SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-Activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated. Results: A total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-Activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate. Conclusion: Sustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients. Trial registration number: NCT01120366; Results.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
DOIs
Publication statusAccepted/In press - 2018 May 26

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Methotrexate
Rheumatoid Arthritis
tocilizumab
Antirheumatic Agents
Retreatment
Paramagnetic resonance
Labels
Joints
Switches

Keywords

  • dmards (biologic)
  • methotrexate
  • rheumatoid arthritis

ASJC Scopus subject areas

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

Cite this

Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate : Results from a prospective randomised controlled study (the second year of the SURPRISE study). / Kaneko, Yuko; Kato, Masaru; Tanaka, Yoshiya; Inoo, Masayuki; Kobayashi-Haraoka, Hitomi; Amano, Koichi; Miyata, Masayuki; Murakawa, Yohko; Yasuoka, Hidekata; Hirata, Shintaro; Tanaka, Eiichi; Miyasaka, Nobuyuki; Yamanaka, Hisashi; Yamamoto, Kazuhiko; Takeuchi, Tsutomu.

In: Annals of the Rheumatic Diseases, 26.05.2018.

Research output: Contribution to journalArticle

Kaneko, Yuko ; Kato, Masaru ; Tanaka, Yoshiya ; Inoo, Masayuki ; Kobayashi-Haraoka, Hitomi ; Amano, Koichi ; Miyata, Masayuki ; Murakawa, Yohko ; Yasuoka, Hidekata ; Hirata, Shintaro ; Tanaka, Eiichi ; Miyasaka, Nobuyuki ; Yamanaka, Hisashi ; Yamamoto, Kazuhiko ; Takeuchi, Tsutomu. / Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate : Results from a prospective randomised controlled study (the second year of the SURPRISE study). In: Annals of the Rheumatic Diseases. 2018.
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abstract = "Objective: To evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate. Methods: The SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-Activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated. Results: A total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-Activity rates were significantly higher in ADD-ON than in SWITCH (55{\%}vs27{\%}, p=0.005). Sustained remission rates at week 104 were 24{\%} for ADD-ON and 14{\%} for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate. Conclusion: Sustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90{\%} of patients. Trial registration number: NCT01120366; Results.",
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AU - Kaneko, Yuko

AU - Kato, Masaru

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 - Tanaka, Eiichi

AU - Miyasaka, Nobuyuki

AU - Yamanaka, Hisashi

AU - Yamamoto, Kazuhiko

AU - Takeuchi, Tsutomu

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N2 - Objective: To evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate. Methods: The SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-Activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated. Results: A total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-Activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate. Conclusion: Sustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients. Trial registration number: NCT01120366; Results.

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