Tocilizumab as monotherapy or combination therapy for treating active rheumatoid arthritis: a meta-analysis of efficacy and safety reported in randomized controlled trials

Teitsma, Xavier M; Marijnissen, Anne Karien; Bijlsma, J. W. J.; Lafeber, Floris P. J. G.; Jacobs, Johannes W. G.

doi:10.1186/s13075-016-1108-9

Cited by 46 publications

(34 citation statements)

References 45 publications

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“…No difference in the frequency of AEs was observed between patients who received TCZ monotherapy and those who received combination therapy. A meta-analysis of TCZ clinical trials [37] and the French real-world ACT-SOLO study [38] similarly found no difference in the frequency of AEs in patients receiving TCZ monotherapy vs. combination therapy. Rates of AEs and SAEs were numerically more frequent in biologic-exposed patients than biologic-naive patients.…”

Section: Discussionmentioning

confidence: 99%

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

Casado¹,

Czirják

Taylor

et al. 2019

Rheumatol Ther

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Introduction The objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis. Methods Data on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive). Results Of 1912 patients enrolled from 16 countries, 639 (33.4%) received TCZ monotherapy and 1273 (66.6%) received TCZ combination therapy. At baseline, 1073 patients (56.1%) were biologic naive and 839 (43.9%) were biologic exposed. At 6 months, 1504 patients (78.7%) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6 months. Efficacy at 6 months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7%; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2%; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups. Conclusion In routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified. Funding F. Hoffmann-La Roche. Electronic supplementary material The online version of this article (10.1007/s40744-019-0150-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

Casado¹,

Czirják

Taylor

et al. 2019

Rheumatol Ther

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“…Tocilizumab is an interleukin-6 inhibitor with efficacy in treating RA in placebo-controlled randomized trials as monotherapy [7] and in combination with conventional disease-modifying antirheumatic drugs (DMARDs) [8,9]. This agent is effective and well tolerated during routine clinical care as intravenous (IV) or subcutaneous formulations [10,11].…”

Section: Introductionmentioning

confidence: 99%

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

Koehm

McIntosh²,

Hofmann³

et al. 2020

Rheumatol Int

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Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical difference for improvement (DAS28-d crit ) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator anti-tumor necrosis factor (TNF) agents. The previously published DAS28-d crit value [DAS28 decrease (improvement) ≥ 1.8] was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-d crit responses and European League Against Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints. A logistic regression model was used to calculate p values for differences in response rates between active agents. Patient-reported outcomes (PROs; pain, global health, function, and fatigue) in DAS28-d crit responder versus non-responder groups were compared with an ANCOVA model. DAS28-d crit individual response rates were 78.2% in tocilizumab-treated patients and 58.2% in anti-TNF-treated patients at week 52 in the ACT-ion study (p = 0.0001) and 90.1% versus 59.1% at week 24 in the ADACTA study (p < 0.0001). DAS28-d crit responses showed greater stability over time (up to 52 weeks) than EULAR good responses. For both active treatments, DAS28-d crit responses were associated with statistically significant improvements in mean PRO values compared with non-responders. The DAS28-d crit response criterion provides robust assessments of individual responses to RA therapy and may be useful for discriminating between active agents in clinical studies and guiding treat-to-target decisions in daily practice.

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“…Although tocilizumab and the TNF blockers are most commonly given in combination with methotrexate, a recent report suggested that tocilizumab was more efficacious than adalimumab (an anti-TNF) in RA patients when given as a monotherapy (27). Furthermore, tocilizumab is only marginally more effective when given in combination with methotrexate as compared with tocilizumab monotherapy (28). This may represent a significant advantage of tocilizumab treatment because many patients cannot tolerate side effects caused by methotrexate therapy.…”

Section: Discussionmentioning

confidence: 99%

A bispecific antibody that targets IL-6 receptor and IL-17A for the potential therapy of patients with autoimmune and inflammatory diseases

Lyman

Lieuw

Richardson

et al. 2018

Journal of Biological Chemistry

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Despite the success of current biological therapeutics for rheumatoid arthritis, these therapies, targeting individual cytokines or pathways, produce beneficial responses in only about half of patients. Therefore, better therapeutics are needed. IL-6 and IL-17A are proinflammatory cytokines in many autoimmune and inflammatory diseases, and several therapeutics have been developed to specifically inhibit them. However, targeting both of these cytokines with a bispecific therapeutic agent could account for their nonoverlapping proinflammatory functions and for the fact that IL-6 and IL-17A act in a positive feedback loop. Here, we present the development of MT-6194, a bispecific antibody targeting both IL-6R and IL-17A that was developed with the FynomAb technology. We also present data from mouse inflammatory disease experiments, indicating that simultaneous inhibition of both IL-6 and IL-17A yields enhanced efficacy compared with inhibition of each cytokine alone.

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Tocilizumab as monotherapy or combination therapy for treating active rheumatoid arthritis: a meta-analysis of efficacy and safety reported in randomized controlled trials

Cited by 46 publications

References 45 publications

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

Individual therapeutic DAS28-dcrit responses differentiate between effectiveness of rheumatoid arthritis therapies and reflect patient-reported outcomes: retrospective analysis of DAS28 responses in comparative tocilizumab studies

A bispecific antibody that targets IL-6 receptor and IL-17A for the potential therapy of patients with autoimmune and inflammatory diseases

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