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Title: Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis.
Authors: Kivitz, Alan
Olech, Ewa
Borofsky, Michael A
Zazueta, Beatriz
Navarro-Sarabia, Federico
Radominski, Sebastião C
Merrill, Joan T
Pacheco-Tena, César
Pei, Jinglan
Nasmyth-Miller, Clare
Pope, Janet E
metadata.dc.subject.mesh: Adult
Antibodies, Monoclonal, Humanized
Antirheumatic Agents
Arthritis, Rheumatoid
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Drug Tolerance
Follow-Up Studies
Injection Site Reaction
Injections, Subcutaneous
Middle Aged
Remission Induction
Severity of Illness Index
Treatment Outcome
Issue Date: 15-Dec-2017
Abstract: To evaluate the longterm efficacy and safety of subcutaneous tocilizumab (TCZ-SC) every 2 weeks (q2w) over 2 years in patients with rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARD). Patients (n = 656) were randomized 2:1 to TCZ-SC 162 mg q2w or placebo-SC q2w plus DMARD. After a 24-week double-blind period, patients (n = 457) were rerandomized to open-label TCZ-SC q2w by means of prefilled syringe or autoinjector. Escape therapy with weekly TCZ-SC was available for patients with inadequate efficacy from Week 12. Maintenance of response and safety to 2 years was assessed. Analyses used nonresponder imputation. The American College of Rheumatology (ACR) 20 response after TCZ-SC was maintained beyond Week 24 and was > 70% at each timepoint. ACR50/70, 28-joint Disease Activity Score remission, and ≥ 0.30 decrease from baseline in the Health Assessment Questionnaire-Disability Index response rates were also maintained after Week 24 in the TCZ-SC arm (≥ 50%, > 25%,> 32% and > 56%, respectively). Following escape for inadequate efficacy, many patients achieved ACR20 at the end of the study, 35% after escape from TCZ-SC, and 63% from placebo. The rates of serious adverse events [(11.20/100 patient-years (PY)] including serious infections (3.25/100 PY) were stable through Week 96. No association between anti-TCZ antibody development and loss of efficacy or adverse events was observed. Efficacy and safety of TCZ-SC q2w was maintained up to 2 years and remained comparable with previously published data for intravenous TCZ. Dose escalation to weekly TCZ-SC was associated with ACR responses in prior nonresponders and was well tolerated.
metadata.dc.identifier.doi: 10.3899/jrheum.161539
ISSN: 0315-162X
Appears in Collections:Producción 2020

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