The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Integrated safety in tocilizumab clinical trials
Open accessAbstract
Introduction: The efficacy and safety of tocilizumab in patients with rheumatoid arthritis have been evaluated in a comprehensive phase 3 program. Patients from these randomized trials could receive tocilizumab treatment in open-label extension trials. Here, the long-term safety profile of tocilizumab, using pooled data from all of these trials, is reported. Methods: Cumulative safety data (as of February 6, 2009) from five core phase 3 trials, two ongoing extension trials, and one clinical pharmacology study were analyzed. Two patient populations were evaluated: an all-control population (n = 4,199), which included all patients randomly assigned in the placebo-controlled portions of the five core studies, and an all-exposed population (n = 4,009), which included patients from any of the eight studies who received at least one dose of tocilizumab. Results: Total exposure to tocilizumab was 8,580 patient years (PY), and total duration of observation was 9,414 PY. Overall adverse event (AE) and serious AE (SAE) rates were 278.2/100 PY and 14.4/100 PY, respectively. These events included serious infections (4.7/100 PY), opportunistic infections (0.23/100 PY), gastrointestinal perforations (0.28/100 PY), malignancy (1.1/100 PY), myocardial infarction (0.25/100 PY), and stroke (0.19/100 PY). The rates of SAEs and serious infections were stable over time; no increase with prolonged exposure was noted. Conclusions: The longer-term safety profile of tocilizumab (mean treatment duration, 2.4 years) is consistent with that observed in the phase 3 studies (duration up to 1 year).
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“Data sources and patient populations Included in this analysis are cumulative safety data from five core phase 3 clinical trials: tOcilizumab Pivotal Trial in methotrexate Inadequate respONders (OPTION) [1], Actemra (Roche; Nutley, NJ, USA) versus Methotrexate double-Blind Investigative Trial In mONotherapy (AMBITION)…”
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The role of IL-6 in host defence against infections: immunobiology and clinical implications
Rose-John, S., Winthrop, K., & Calabrese, L. (2017) · Nature Reviews Rheumatology · doi:10.1038/nrrheum.2017.83 · Cited by 424
Tocilizumab: A review in rheumatoid arthritis
Scott, L. J. (2017) · Drugs · doi:10.1007/s40265-017-0829-7 · Cited by 419
Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease
Sandborn, W. J., Feagan, B. G., Loftus, E. V., Peyrin-Biroulet, L., Van Assche, G., D’Haens, G., Schreiber, S., Colombel, J.-F., Lewis, J. D., Ghosh, S., et al. (2020) · Gastroenterology · doi:10.1053/j.gastro.2020.01.047 · Cited by 322
Khanna, D., Denton, C. P., Lin, C. J. F., van Laar, J. M., Frech, T. M., Anderson, M. E., Baron, M., Chung, L., Fierlbeck, G., Lakshminarayanan, S., et al. (2018) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2017-211682 · Cited by 265
Self-citationBiologics for targeting inflammatory cytokines, clinical uses, and limitations
Rider, P., Carmi, Y., & Cohen, I. (2016) · International Journal of Cell Biology · doi:10.1155/2016/9259646 · Cited by 226
Sieper, J., Porter-Brown, B., Thompson, L., Harari, O., & Dougados, M. (2014) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2013-203559 · Cited by 184
Strangfeld, A., Richter, A., Siegmund, B., Herzer, P., Rockwitz, K., Demary, W., Aringer, M., Meißner, Y., Zink, A., & Listing, J. (2017) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2016-209773 · Cited by 174
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Weinblatt, M. E., Mease, P., Mysler, E., Takeuchi, T., Drescher, E., Berman, A., Xing, J., Zilberstein, M., Banerjee, S., & Emery, P. (2015) · Arthritis & Rheumatology · doi:10.1002/art.39249 · Cited by 98
Yamamoto, K., Goto, H., Hirao, K., Nakajima, A., Origasa, H., Tanaka, K., Tomobe, M., & Totsuka, K. (2015) · The Journal of Rheumatology · doi:10.3899/jrheum.141210 · Cited by 91
Safety and efficacy of tocilizumab for the treatment of rheumatoid arthritis
Ogata, A., Hirano, T., Hishitani, Y., & Tanaka, T. (2012) · Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders · doi:10.4137/cmamd.s7371 · Cited by 61
Metadata
- Authors
- Schiff, M. H., Kremer, J. M., Jahreis, A., Vernon, E., Isaacs, J. D., & van Vollenhoven, R. F.
- Venue
- Arthritis Research & Therapy
- Published
- 2011-09-01
- Volume
- 13
- Issue
- 5
- Pages
- R141-R141
- ISSN
- 1478-6354 (ISSN-L)
- OpenAlex
- W2049400198
- Cited by
- 367
- References
- 3
- FWCI
- 15.82
- Type
- journal article
- Language
- en
- Open access
- gold
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