Trastuzumab is a recombinant immunoglobulin G1 monoclonal antibody used to treat human epidermal growth factor receptor 2 (HER2) cancers. Trastuzumab-induced interstitial pneumonitis is a rare adverse effect reported in a few patients. Interstitial pneumonitis presents as symptoms of dyspnea, hypoxia, cough, and fever. If the patient is treated early, corticosteroids can slow or reverse the disease progression. A 41-year-old woman presented with dyspnea and a dry cough three weeks after her third cycle of trastuzumab therapy for breast cancer. A diagnosis of trastuzumab-induced interstitial pneumonitis was made after multiple other disease processes were ruled out. The patient was started on methylprednisolone while inpatient and transitioned to prednisone for outpatient therapy. The patient was maintained on 2-3L of oxygen throughout her hospital stay and was discharged on 3L of oxygen through nasal cannula. Trastuzumab was never restarted after discharge. There have been many trials evaluating the safety, efficacy, and optimal treatment regimen of trastuzumab, but there are only a few reports of interstitial pneumonitis adverse reaction. The lack of correlation and limited cases make this adverse effect very difficult to diagnose and monitor. New trials and case reports can bring an insight into contributing factors, symptoms at onset, and treatment for future patients. With the increase in use of trastuzumab therapy, physicians should be aware of how to diagnose and treat the rare adverse reaction of trastuzumab-induced interstitial pneumonitis.

2020-08-01·Cancer Chemotherapy and Pharmacology4区 · 医学

A randomized, double-blind, parallel-group, single‑dose, pharmacokinetic bioequivalence study of INTP24 and bevacizumab in healthy adult men

4区 · 医学

Article

作者: Patel, Akash ; Singh, Inderjeet ; Jose, Vinu ; Patel, Ronak

PURPOSETo demonstrate pharmacokinetic (PK) equivalence and to compare safety of INTP24 (bevacizumab biosimilar) with that of US-bevacizumab and EU-bevacizumab in healthy male subjects.METHODSIn this randomized, parallel-group, double-blind study, male subjects were randomized (1:1:1) to receive a single 1 mg/kg intravenous infusion of either INTP24, US-bevacizumab, or EU-bevacizumab. The primary endpoint was area under serum concentration (AUC) from time zero to infinity (AUC_0-∞). Secondary endpoints were AUC from time zero to last quantifiable concentration (AUC_0-t), maximum concentration (C_max), other PK parameters, immunogenicity, and safety.RESULTSA total of 117 subjects (39/group) were dosed; 113 subjects (37, 37, and 39 in INPT24, US-bevacizumab, and EU-bevacizumab groups, respectively) completed the study and were included in the PK analysis. Baseline demographics were similar across the three groups. The 90% confidence intervals (CI) of geometric mean ratios (GMR) of ln-transformed AUC_0-∞ and C_max of INTP24 relative to US-bevacizumab and EU-bevacizumab were within the acceptance range of 80%-125% (INTP24 vs. US-bevacizumab, 96.55-112.51% and 99.16-112.79%: INTP24 vs. EU-bevacizumab, 94.84-110.17% and 96.32-109.28%). The 90% CIs of GMRs for AUC_0-t was also within 80-125% for INTP24 vs. US-bevacizumab and INTP24 vs. EU-bevacizumab. Safety and immunogenicity profiles were similar across the three groups. Twenty-one (17.95%) subjects experienced at least one AE and 9 (7.69%) were ADA positive. One treatment-related serious adverse event (varicella zoster infection) was reported in INTP24 group.CONCLUSIONThis study demonstrated PK bioequivalence of INTP24 to US-bevacizumab and EU-bevacizumab in healthy male subjects and showed similar safety and immunogenicity profiles across the treatment groups.

2020-07-01·Breastfeeding Medicine4区 · 医学

Belimumab Concentrations in Maternal Serum and Breast Milk During Breastfeeding and the Safety Assessment of the Infant: A Case Study

4区 · 医学

Article

作者: Saito, Jumpei ; Murashima, Atsuko ; Goto, Mikako ; Yakuwa, Naho ; Yamatani, Akimasa ; Ishizuka, Tatsuo

Background: Belimumab is a recombinant human immunoglobulin G1 lambda monoclonal antibody that binds soluble B lymphocyte stimulator protein with high affinity and inhibits its biological activity. Belimumab is not recommended for breastfeeding women due to insufficient data about its excretion into breast milk. In this study, we measured belimumab concentrations in the breast milk of one nursing mother diagnosed with mixed connective tissue disease (MCTD) and evaluated the health of her breastfed infant. Materials and Methods: Maternal serum and breast milk belimumab concentrations were collected three times (2 weeks after the first dose, the day after the second dose, and 7 weeks after the second dose) after ethical approval and informed consent. An enzyme-linked immunosorbent assay was used to detect belimumab in serum and breast milk samples. Case Report: A 39-year-old para 4 female was diagnosed with MCTD. The serum concentrations at three times were 29.45, 76.82, and 33.95 mcg/mL. The concentrations in breast milk were 0.12, 0.17, and 0.12 mcg/mL. The milk-to-serum concentration ratios at each sampling point were 0.0041, 0.0022, and 0.0035, respectively. Her infant experienced no health problems. Routine vaccinations were administered without any adverse effects such as infection or immunoreaction. Discussion and Conclusions: Breast milk levels of belimumab ranged from 1/200 to 1/500 of those in serum, and no harmful effect occurred in her infant. This is the first study reporting belimumab concentrations in human breast milk. Further studies are needed to elucidate the impact of exposure on breastfeeding infants.

项与贝伐珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的新闻（医药）

2023-05-18

·drugs

Peresolimab Found to Be Efficacious for Rheumatoid Arthritis

THURSDAY, May 18, 2023 -- Peresolimab, a humanized immunoglobulin G1 monoclonal antibody designed to stimulate the endogenous programmed cell death protein 1 (PD-1) inhibitory pathway, is efficacious for patients with rheumatoid arthritis , according to a study published in the May 18 issue of the New England Journal of Medicine . Jay Tuttle, Ph.D., from Eli Lilly in San Diego, and colleagues conducted a phase 2a trial involving adults with moderate-to-severe rheumatoid arthritis who had an inadequate response to, a loss of response to, or unacceptable side effects with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) or to biologic or targeted synthetic DMARDs. Participants were randomly assigned to receive 700 mg of peresolimab, 300 mg of peresolimab, or placebo intravenously once every four weeks in a 2:1:1 ratio. The researchers found that the change from baseline in the Disease Activity Score for 28 joints based on the C-reactive protein level was significantly greater in the 700-mg peresolimab group versus the placebo group at week 12 (least-squares mean change, −2.09 ± 0.18 versus −0.99 ± 0.26). With response to the percentages of patients with American College of Rheumatology 20 (ACR20) response, but not the ACR50 and ACR70 responses, the results favored the 700-mg dose over placebo. "Peresolimab is a humanized monoclonal antibody designed to stimulate PD-1, with the goal of suppressing T-cell activation," write the authors of an accompanying editorial. "This novel approach provides an exciting therapeutic mechanism for the treatment of rheumatoid arthritis and potentially other autoimmune diseases in which antigen-activated lymphocytes play a pathogenic role." The study was funded by Eli Lilly, the manufacturer of peresolimab. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required) Posted May 2023

临床结果临床2期免疫疗法

100 项与贝伐珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的药物交易

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