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)

Autor: Koichi Amano, Yuko Kaneko, Hayato Nagasawa, Tsutomu Takeuchi, Tatsuya Atsumi, Yohko Murakawa, Masayuki Miyata, Hitomi Kobayashi-Haraoka, Eiichi Tanaka, Yoshiya Tanaka, Kazuhiko Yamamoto, Nobuyuki Miyasaka, Masayuki Inoo, Shintaro Hirata, Hisashi Yamanaka, Hidekata Yasuoka
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Male
0301 basic medicine
DMARDs (biologic)
Severity of Illness Index
Gastroenterology
Arthritis
Rheumatoid
chemistry.chemical_compound
0302 clinical medicine
Clinical endpoint
Immunology and Allergy
Prospective Studies
Clinical efficacy
Joint destruction
Drug Substitution
Middle Aged
C-Reactive Protein
Treatment Outcome
Antirheumatic Agents
Rheumatoid arthritis
Disease Progression
Drug Therapy
Combination
Female
medicine.drug
musculoskeletal diseases
medicine.medical_specialty
Scoring system
Immunology
Rheumatoid Arthritis
Antibodies
Monoclonal
Humanized
General Biochemistry
Genetics and Molecular Biology
03 medical and health sciences
Tocilizumab
Rheumatology
Internal medicine
medicine
Humans
In patient
Disease Activity
030203 arthritis & rheumatology
business.industry
Clinical and Epidemiological Research
medicine.disease
Surgery
Treatment
Radiography
Methotrexate
030104 developmental biology
chemistry
business
Zdroj: Annals of the Rheumatic Diseases
ISSN: 0003-4967
Popis: ObjectiveTo compare the efficacy and safety between tocilizumab added to methotrexate and tocilizumab switched from methotrexate in patients with active rheumatoid arthritis (RA).MethodsThis 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.ResultsOf 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.ConclusionsIn 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 numberNCT01120366.
Databáze: OpenAIRE
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