• J Clin Rheumatol · Jun 2017

    Comparative Study

    Safety of Tofacitinib in the Treatment of Rheumatoid Arthritis in Latin America Compared With the Rest of the World Population.

    • Oswaldo M Castañeda, Felix J Romero, Ariel Salinas, Gustavo Citera, Eduardo Mysler, Oscar Rillo, Sebastiao C Radominski, Mario H Cardiel, Juan J Jaller, Carlos Alvarez-Moreno, Dario Ponce de Leon, Graciela Castelli, Erika G García, Kenneth Kwok, and Ricardo Rojo.
    • From the *Clínica Angloamericana, Lima, Peru; †Instituto Peruano del Hueso y la Articulación, Lima, Peru; ‡Hospital Nacional Alberto Sabogal, Bellavista, Callao, Peru; §Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina; ∥Organización Médica de Investigación, Buenos Aires, Argentina; ¶Section of Rheumatology, Department of Medicine, Hospital Dr I Pirovano, Ciudad Autónoma de Buenos Aires, Argentina; #Universidade Federal do Paraná, Curitiba, Brazil; **Centro de Investigación Clínica de Morelia, Morelia, México; ††Centro de Reumatología y Ortopedia, Barranquilla, Colombia; ‡‡Facultad de Medicina, Universidad Nacional de Colombia, Bogotá, Colombia; §§Pfizer Inc., Lima, Peru; ∥∥Pfizer Inc., Buenos Aires, Argentina; ¶¶Pfizer Inc., Collegeville, PA, USA; ##Pfizer Inc., New York, NY, USA; and ***Pfizer Inc., Groton, CT, USA.
    • J Clin Rheumatol. 2017 Jun 1; 23 (4): 193-199.

    ObjectiveRheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population.MethodsData were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations.ResultsThis analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years]).ConclusionThis analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…