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Predictors of exposure, therapeutic and adverse effects of tocilizumab used in the treatment of rheumatoid arthritis.








Predictors of exposure, therapeutic and adverse effects of tocilizumab used in the treatment of rheumatoid arthritis.


Ahmad Y Abuhelwa


University of South Australia






12 Jun 2019


Tocilizumab is an important treatment option for rheumatoid arthritis. However, response and toxicity to tocilizumab can be highly unpredictable, with up to 40% of the patients who initiate not responding, and approximately 40% experiencing some toxicity. Using the diverse range of data collected from clinical trials, it is possible to develop clinical tools that enable improved prediction of therapeutic and adverse outcomes of patients using tocilizumab in the treatment of rheumatoid arthritis. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, discontinue or change dosing of tocilizumab.



[{ "PostingID": 1350, "Title": "ROCHE-WA17822", "Description": "A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis" },{ "PostingID": 1351, "Title": "ROCHE-WA17823", "Description": "A randomized, double-blind study of safety and prevention of structural joint damage during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis" },{ "PostingID": 1352, "Title": "ROCHE-WA17824", "Description": "A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe active rheumatoid arthritis" },{ "PostingID": 1353, "Title": "ROCHE-WA18062", "Description": "A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis and inadequate response to anti-TNF therapy" },{ "PostingID": 1354, "Title": "ROCHE-WA18063", "Description": "A randomized, double-blind study of the effect of tocilizumab on reduction in signs and symptoms in patients with moderate to severe active rheumatoid arthritis and inadequate response to DMARD therapy" },{ "PostingID": 1355, "Title": "ROCHE-WA18695", "Description": "Long-term extension study of safety during treatment with tocilizumab in rheumatoid arthritis patients completing treatment in WA17822" },{ "PostingID": 1356, "Title": "ROCHE-WA18696", "Description": "Long-term extension study of safety during treatment with tocilizumab in rheumatoid arthritis patients completing treatment in tocilizumab core studies WA18062, WA18063 and WA17824" },{ "PostingID": 2642, "Title": "ROCHE-NA25220", "Description": "A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis" },{ "PostingID": 2644, "Title": "ROCHE-WA19926", "Description": "Multi-center, randomized, double-blind, parallel group study of the safety, disease remission & prevention of structural joint damage during treatment with tocilizumab as a monotherapy & in combination with methotrexate versus methotrexate in pts with early moderate to severe rheumatoid arthritis" },{ "PostingID": 2645, "Title": "ROCHE-WA22762", "Description": "A Phase III multicenter, double blind, placebo controlled, parallel group study of the safety and efficacy of a subcutaneous formulation of tocilizumab administered once or twice weekly versus an intravenous administration of tocilizumab administered once every four weeks." },{ "PostingID": 2647, "Title": "ROCHE-WA19924", "Description": "A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis" },{ "PostingID": 4806, "Title": "ROCHE-MA21488", "Description": "(ACT-RAY) Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients" },{ "PostingID": 19791, "Title": "ROCHE-ML21136", "Description": "A randomized, double-blind, parallel-group study to evaluate the safety and efficacy of tocilizumab (TCZ) versus placebo in combination with disease modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis (RA)" }]

Statistical Analysis Plan