Biologics in therapy最新文献_第3页

Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data. 转换重组人生长激素的效果:三期临床数据的比较分析。

Biologics in therapy Pub Date : 2011-12-16 eCollection Date: 2011-01-01 DOI: 10.1007/s13554-011-0004-8

Tomasz Romer, Markus Zabransky, Mieczyslaw Walczak, Mieczyslaw Szalecki, Sigrid Balser

{"title":"Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data.","authors":"Tomasz Romer, Markus Zabransky, Mieczyslaw Walczak, Mieczyslaw Szalecki, Sigrid Balser","doi":"10.1007/s13554-011-0004-8","DOIUrl":"https://doi.org/10.1007/s13554-011-0004-8","url":null,"abstract":"Introduction: Recombinant human growth hormone (rhGH) is effective and safe when used to treat growth hormone deficiency (GHD) in children. However, it has been suggested that switching between different types of rhGH can have a detrimental effect on patients.Methods: The current analysis assessed the efficacy and safety of rhGH in children who received continuous Omnitrope® (Sandoz GmbH, Kundl, Austria) therapy either with lyophilized powder for solution or ready-to-use solution, with children who received 9 months of treatment with Genotropin® (Pfizer Limited, Sandwich, UK) followed by Omnitrope solution thereafter. Changes to height, height SD score (SDS), height velocity SDS, insulin-like growth factor (IGF-1) levels, and IGF binding protein (IGFBP-3) levels were assessed using data from three trials.Results: Baseline demographics of the three study groups were similar. Over an 18-month period there were no observable differences between the three groups with respect to height, height SDS, height velocity SDS, IGF-1 levels, and IGFBP-3 levels. This result was corroborated by the model data, whereby most data points for Omnitrope-treated children fell within the defined limits of the prediction model based on Genotropin data. Few adverse drug reactions (ADRs) occurred.Conclusions: Switching from Genotropin to Omnitrope solution has no impact on efficacy or safety in children with GHD, and the various rhGH preparations are well tolerated.","PeriodicalId":89899,"journal":{"name":"Biologics in therapy","volume":"1 ","pages":"5"},"PeriodicalIF":0.0,"publicationDate":"2011-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/s13554-011-0004-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32003702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 24

New Frontiers in Subcutaneous Immunoglobulin Treatment. 皮下注射免疫球蛋白治疗的新领域。

Biologics in therapy Pub Date : 2011-12-14 eCollection Date: 2011-01-01 DOI: 10.1007/s13554-011-0009-3

Stephen Jolles, Mark R Stein, Hilary J Longhurst, Michael Borte, Bruce Ritchie, Matthias H Sturzenegger, Melvin Berger

{"title":"New Frontiers in Subcutaneous Immunoglobulin Treatment.","authors":"Stephen Jolles, Mark R Stein, Hilary J Longhurst, Michael Borte, Bruce Ritchie, Matthias H Sturzenegger, Melvin Berger","doi":"10.1007/s13554-011-0009-3","DOIUrl":"10.1007/s13554-011-0009-3","url":null,"abstract":"Subcutaneous immunoglobulin (SCIG) treatment provides stable serum immunoglobulin G (IgG) levels, is associated with fewer systemic adverse events than intravenous immunoglobulin (IVIG) treatment, and offers the convenience of home therapy. In clinical practice, IVIG is still used preferentially for initiation of treatment in newly diagnosed patients with primary immunodeficiency (PI) and for immunomodulatory therapy, such as treatment of peripheral neuropathies, when high doses are believed to be necessary. The authors discuss recent experience in using SCIG in place of IVIG in these settings. SCIG has been successfully used for initiation of therapy in previously untreated PI patients. Seventeen of 18 PI patients achieved serum IgG levels ≥5 g/L after the loading phase. Daily treatment was well tolerated and provided opportunities for patient/parent training in self-infusion. SCIG has been used for maintenance therapy in multifocal motor neuropathy (MMN) in three recent clinical trials, with good efficacy and tolerability results. Seven of eight MMN patients maintained serum IgG levels of 14-22 g/L with a mean dose of 272 mg/kg/week, had stable muscle strength, and felt comfortable with self-administration. Four patients with polymyositis or dermatomyositis achieved improvement in serum creatine kinase levels and muscle strength with SCIG therapy. Recent experience with SCIG suggests that traditional concepts of immunoglobulin therapy may be challenged to increase available therapy options. SCIG can be used to achieve high IgG levels within several days in untreated PI patients and to maintain high serum levels, as shown in patients with MMN.","PeriodicalId":89899,"journal":{"name":"Biologics in therapy","volume":"1 ","pages":"3"},"PeriodicalIF":0.0,"publicationDate":"2011-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ca/14/13554_2011_Article_9.PMC3873072.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32003700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Rotarix in Japan: Expectations and Concerns. 日本的扶轮社:期望与关注。

Biologics in therapy Pub Date : 2011-12-14 eCollection Date: 2011-01-01 DOI: 10.1007/s13554-011-0007-5

Osamu Nakagomi, Toyoko Nakagomi

{"title":"Rotarix in Japan: Expectations and Concerns.","authors":"Osamu Nakagomi, Toyoko Nakagomi","doi":"10.1007/s13554-011-0007-5","DOIUrl":"https://doi.org/10.1007/s13554-011-0007-5","url":null,"abstract":"A live-attenuated, orally-administered, monovalent, human rotavirus vaccine, Rotarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium), was licensed and launched in 2011 as the first rotavirus vaccine in Japan. The rotavirus causes a substantial disease burden with an estimated 790,000 outpatient visits, 27,000-78,000 hospitalizations, and approximately 10 deaths each year in Japan. Since a recent clinical trial showed that Rotarix was as efficacious in Japan as in other industrialized countries, it is expected that the annual number of rotavirus hospitalizations will be reduced to between 1000-3000, and that outpatient visits will be reduced to 200,000. The universal rotavirus immunization program with Rotarix was calculated to be at the threshold of being cost-effective, even from the healthcare perspective, and it was highly cost-effective from the societal perspective, assuming that Rotarix is co-administered with other childhood vaccines. While Rotarix contains only a single G1P[8] human rotavirus, the postlicensure studies in Brazil showed that Rotarix provided a 75%-85% protective efficacy against severe dehydrating diarrhea or hospitalizations due to fully-heterotypic G2P[4] strains. While postlicensure studies detected a small and finite risk of intussusception associated with the administration of Rotarix, the authors conclude that Rotarix is safe to administer to infants between 6-12 weeks of age for the first dose and by 24 weeks of age for the second dose. However, the authors strongly discourage the delayed administration of the first dose between 13-20 weeks of age, which is allowed without any warning. Given the high incidence of naturally-occurring intussusception in Japan (185 cases per 100,000 children/year among children less than 1 year of age), this should prevent pediatricians and parents from having ill-perceptions of Rotarix being associated with an increased number of temporally-associated intussusception, and fully appreciate the benefit of the rotavirus vaccine.","PeriodicalId":89899,"journal":{"name":"Biologics in therapy","volume":"1 ","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2011-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/s13554-011-0007-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32003701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Letter from the Editor. 编辑来信。

Biologics in therapy Pub Date : 2011-09-23 eCollection Date: 2011-01-01 DOI: 10.1007/s13554-011-0002-x

Yusuf Yazici

引用次数: 0

Clinical consequences of reduced dosing schedule during treatment of a patient with Pompe's disease. 庞贝病患者治疗期间减少给药计划的临床后果。

Biologics in therapy Pub Date : 2011-08-12 eCollection Date: 2011-01-01 DOI: 10.1007/s13554-011-0001-y

Emilia Barrot Cortés, Juana María Barrera Chacón

引用次数: 5