Efficacy and safety of rituximab in Japanese patients with relapsed chronic immune thrombocytopenia refractory to conventional therapy View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2015-12

AUTHORS

Yoshitaka Miyakawa, Shinya Katsutani, Takahiro Yano, Shosaku Nomura, Kaichi Nishiwaki, Yoshiaki Tomiyama, Masaaki Higashihara, Yukari Shirasugi, Masakatsu Nishikawa, Katsutoshi Ozaki, Takayuki Abe, Kayoko Kikuchi, Yuzuru Kanakura, Kingo Fujimura, Yasuo Ikeda, Shinichiro Okamoto

ABSTRACT

Primary immune thrombocytopenia (ITP) is an autoimmune disease mediated by the production of autoantibody against platelets. Rituximab, an anti-CD20 antibody, is reported to be useful for treatment of ITP. In Japan, however, robust evidence on this treatment has not been accumulated. Hence, we conducted this open-label phase III clinical trial to confirm the efficacy and safety of rituximab, administered at 375 mg/m² once per week at weekly intervals for 4 consecutive weeks in Japanese patients with chronic ITP, who had relapsed and were refractory to conventional therapy. The primary endpoint was defined as the percentage of patients with a platelet count above 50 × 10⁹/L at week 24 after the first dose of rituximab, which was 30.8% of 26 patients (95% confidence interval 14.3-51.8%). Although the lower confidence limit of primary endpoint failed to meet the pre-specified threshold of 20%, the clinical efficacy of rituximab is substantial in consideration of the 2% response rate in the placebo arm in other clinical studies in patients with chronic ITP. We conclude that rituximab is clinically useful and safe in the treatment of Japanese patients with chronic ITP, achieving the goal of maintaining platelet count and reducing risk of bleeding while minimizing treatment-related toxicity. More... »

PAGES

654-661

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-015-1887-9

DOI

http://dx.doi.org/10.1007/s12185-015-1887-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1052321757

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26466831


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Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s12185-015-1887-9'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s12185-015-1887-9'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s12185-015-1887-9'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s12185-015-1887-9'


 

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