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Medscape
21-05-2025
- Health
- Medscape
New Tool IDs Women at High Risk for Postpartum Depression
LOS ANGELES — Researchers have developed and externally validated a simple, machine learning model that can help identify women at a high risk for postpartum depression (PPD) immediately after childbirth, even before they leave the hospital. Untreated PPD is a significant contributor to maternal morbidity and mortality. It's estimated to play a role in up to 10% of maternal deaths by suicide. Earlier identification will improve the health of patients as they won't have to wait to begin treatment for 6 or 8 weeks after delivery, when symptoms might become much more severe, lead investigator Mark A. Clapp, MD, maternal-fetal medicine specialist at Massachusetts General Hospital and assistant professor in the Department of Obstetrics and Gynecology, Harvard Medical School, both in Boston, told Medscape Medical News . 'It's an opportunity for collaboration between obstetricians and psychiatrists to ensure high-risk patients are seen promptly,' said Clapp. The findings were presented on May 19 at American Psychiatric Association (APA) 2025 Annual Meeting and simultaneously published online in The American Journal of Psychiatry. A Common Problem PPD, which can affect up to 15% of women after childbirth, is linked to an increased risk for suicide and self-harm. The condition has a profound impact on a woman's physical and mental health, ability to function, and relationships with her newborn and family. Until 2023, the American College of Obstetricians and Gynecologists (ACOG) recommended first PPD screening at the postpartum visit. ACOG now recommends screening at the initial prenatal visit, later in pregnancy, and at the postpartum visit. The Edinburgh Postnatal Depression Scale (EPDS) has traditionally been used to screen for the condition. Clapp noted only an estimated 60% of women appear at their postpartum visit, 'so about 4 in 10 patients are actually not presenting for postpartum care,' he said. The study included 29,168 women (media age, 33 years; 70% White) with available EPDS scores and no recent history of a depressive disorder, who gave birth at two large academic hospitals (Brigham and Women's Hospital and Massachusetts General Hospital), and six surrounding community-based hospitals sharing a common electronic health record (EHR) system. A PPD risk stratification model based on EHRs of women having a baby in a hospital makes sense given the widespread use of EHRs in healthcare facilities, where over 98% of pregnant women deliver, said Clapp. Researchers divided participants into a model development group (15,018 participants delivering at five hospitals) and a model validation group (14,150 participants delivering at three hospitals). All information for the model was readily available through EHRs, including maternal medical history, medication use, pregnancy history, and demographic factors. Researchers also incorporated other factors known or hypothesized to influence the risk for PPD such as maternal age; education level; marital status; primary language; public or private insurance; and pregnancy factors such as gestational age, mode of delivery, number of prenatal visits, and length of hospital stay. The primary outcome was PPD, defined as the presence of a mood disorder, an antidepressant prescription, or a positive screen on the EPDS (score ≥ 13) within 6 months of delivery. For both the training and testing sets, researchers assessed model discrimination by the area under the receiver operating characteristic curve (AUROC), as well as positive predictive value (PPV) and negative predictive value (NPV) using a screen-positive threshold and a set specificity of 90%. High Specificity Of the total number of participants, 9.2% met at least one criterion for PPD within 6 months of delivering their baby. Top factors contributing to the risk for PPD included anxiety/fear-related disorders, antiemetic use, headache disorders, gastrointestinal disorders, and prenatal EPDS score. For the primary model, the AUROC was 0.750 (95% CI, 0.721-0.778), indicating the model had good discrimination. The Brier score was 0.073 (95% CI, 0.067-0.080), indicating the model was well calibrated. At the set threshold of 90% specificity, the PPV was 24.4% (95% CI, 21.3%-27.6%) and the NPV was 94.7% (95% CI, 93.9%-95.5%). In the external validity cohort, the AUROC was 0.721 (95% CI, 0.709-0.736) and the Brier score was 0.087 (95% CI, 0.083-0.091). At a specificity of 90%, the PPV was 28.8% (95% CI, 26.7%-30.8%) and the NPV was 92.2% (95% CI, 91.8%-92.7%). 'Using the predefined specificity, we were able to identify about 30% of individuals who were predicted to be at high risk where the diagnosis of postpartum depression occurred,' said Clapp. 'Remember, the overall population risk was about 10%, but of those that we flagged as high risk, the rate of postpartum depression was 30% — or three times the population rate.' In addition to distinguishing between higher- and lower-risk populations, the model performed similarly across patient subgroups by race, ethnicity, age, and hospital type, suggesting the model could be applied equitably in diverse populations, said Clapp. The researchers hope to pair the model with tailored interventions, which in some cases could merely involve a phone call during the postpartum period, said Clapp. 'People at high risk for postpartum depression benefit from a simple phone call, so having a nurse or doctor call them to say, 'Hey, how are you doing?'' can make a big difference, he noted. A limitation of the study is that it only reflects practice patterns in eastern Massachusetts and southern New Hampshire in a single health system. Other limitations were that most patients were White, college-educated, and privately insured, and misclassification may have occurred, as is the case with any study using diagnostic codes. 'We're working to integrate this model into our electronic health record to facilitate real-time predictions' of high PPD risk, said Clapp. The team is also investigating how the model can be used to reduce the incidence, severity, and consequences of PPD. Clinically Important Tool Commenting for Medscape Medical News , reproductive psychiatrist Misty Richards, MD, associate clinical professor, Department of Psychiatry and OB-GYN, University of California at Los Angeles, noted that PPD is the most common complication of childbirth, highlighting the need for better diagnostics. 'We're talking about 1 in 5 women', many of whom, especially those with no history of depression, 'don't tend to get diagnosed,' said Richards, who was not part of the research. 'We try to catch people with postpartum depression before it becomes a forest fire' but 'oftentimes we miss it,' she said. 'Having predictive tools like thisis very, very important clinically, so we can catch things early.' Only one medication — zuranolone, a GABA A receptor–positive allosteric modulator — is approved by the US Food and Drug Administration for PPD, said Richards. Ned Kalin, MD, professor and chair, Department of Psychiatry, and director of the HealthEmotions Research Institute, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, who was not part of the study, highlighted in a press briefing that patients in the study who developed PPD didn't have a history of depression. 'These are people that otherwise would probably go completely undetected, so this is really a critical advance in that regard.'
Yahoo
27-03-2025
- Health
- Yahoo
TIVDAK® (tisotumab vedotin) Approved by Japan Ministry of Health, Labour and Welfare for the Treatment of Advanced or Recurrent Cervical Cancer that has Progressed on or after Chemotherapy
Media ReleaseCOPENHAGEN, Denmark; March 27, 2025 TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in Japan Approval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapy Rising cervical cancer incidence and mortality rates in Japan signify need for new treatment options Genmab A/S (Nasdaq: GMAB) today announced that the Japan Ministry of Health, Labour and Welfare has approved TIVDAK® (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only ADC to be approved for people living with cervical cancer in Japan. In recent years, cervical cancer incidence and mortality rates have increased in Japan, particularly among women under age 50.i,ii,iii Moreover, patients with recurrent or metastatic cervical cancer whose disease has progressed after first-line therapy have limited treatment options. 'Patients with advanced or recurrent cervical cancer, in general, have a poor prognosis. The advent of new treatment options, especially for second-line or later treatment, is much needed,' said Aikou Okamoto, M.D., Ph.D., Chief Professor, Department of Obstetrics and Gynecology at The Jikei University School of Medicine. 'Cervical cancer treatment has advanced in recent years, but it is very meaningful that the approval of tisotumab vedotin as an ADC has increased the number of treatment options with a new mechanism of action that is expected to prolong overall survival. This is good news for patients and healthcare professionals.' The approval is based on data from the randomized, open-label, global Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy. The trial included 502 patients, 101 of which were Japanese. The trial met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in risk of death (HR: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038) compared to chemotherapy. Median OS was 11.5 months [95% CI: 9.8-14.9] among patients treated with TIVDAK compared to 9.5 months [95% CI: 7.9-10.7] for patients who received chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met. Adverse drug reactions occurred in 219 (87.6%) of 250 patients (including 50 Japanese patients) treated with TIVDAK. The most common (≥20%) adverse reactions included conjunctivitis (n=76; 30.4%), nausea (n=73; 29.2%), peripheral sensory neuropathy (n=67; 26.8%), alopecia (n=61; 24.4%), and epistaxis (n=57; 22.8%), at the data cutoff date of July 24, 2023. 'As a company, we understand the urgent need for patients with advanced cervical cancer whose disease has progressed,' said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. 'This approval marks an important step forward in transforming the treatment paradigm in Japan, ultimately bringing new hope and possibility to patients and their loved ones.' About the innovaTV 301 TrialThe innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator's choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received one or two prior systemic regimens in the recurrent or metastatic setting. Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate. The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups. For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit About Tisotumab VedotinTisotumab vedotin (approved under the brand name TIVDAK® in the U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab's human monoclonal antibody directed to tissue factor (TF) and Pfizer's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. About the Pfizer and Genmab Collaboration Tisotumab vedotin is co-developed and co-commercialized globally by Genmab and Pfizer, under an agreement in which the companies share costs and profits. With respect to the commercialization of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer, Genmab leads commercialization in Japan and all other regions globally, outside the United States and China. In these regions, Pfizer partners with Genmab and Zai Lab, respectively, on commercialization. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. Contact: Caitlin Craparo, Senior Director, Commercialization CommunicationsT: +1 609 255 7397; E: cacr@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@ This Media Release contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. i Cancer Statistics Cervix, National Cancer Center, Cancer Information Service, Accessed 14 Feb. Trends in Cancer Incidence and Mortality Rates, World Health Organization, Accessed 14 Feb. For Correct Understanding of Cervical Cancer and HPV Vaccine, Japan Society of Obstetrics and Gynecology, Accessed 14 Feb. 2025. Media Release no. i06CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 270325 MRi06 TIVDAK Japan ApprovalSign in to access your portfolio
