Three-Year Real-World Study Compares Burosumab Treatment with Oral Phosphate and Active Vitamin D in Adults with XLH

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Postmedia has not reviewed the content. by GlobeNewswire Three-Year Real-World Study Compares Burosumab Treatment with Oral Phosphate and Active Vitamin D in Adults with XLHAuthor of the article:Publication in the Journal of Bone and Mineral Research offers new insight into the long-term XLH treatment experienceTHIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountPRINCETON, N.J., Oct. 14, 2026 (GLOBE NEWSWIRE) — Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), today announced the publication of three-year real-world findings from an interim analysis of the XLH Disease Monitoring Program (DMP) in the Journal of Bone and Mineral Research. The analysis assessed serum phosphate levels and patient-reported pain, stiffness, and physical function at years 1 and 3 among adults with X-linked hypophosphatemia (XLH) treated with burosumab or oral phosphate and active vitamin D (Pi/D). Read the full study here.This advertisement has not loaded yet, but your article continues below.“Real-world evidence in rare diseases like XLH is invaluable, helping to deepen our understanding of the patient experience and treatment outcomes beyond clinical trials,” said lead author Steven W. Ing, MD, MSCE, Professor of Clinical Medicine, Division of Endocrinology, Diabetes and Metabolism, The Ohio State University Wexner Medical Center. “These findings add to the broader evidence base for burosumab and can help inform clinical decision-making and the ongoing evolution of care for adults living with XLH.”Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againXLH is a rare, lifelong, progressive genetic disease that causes excessive phosphorus loss, weakening the bones and muscles in children and adults, leading to skeletal deformities.1 The XLH DMP is a prospective, 10-year, observational study of adults and children with XLH in the US, Canada, and Latin America. It is designed to characterize XLH disease presentation and progression, and to prospectively assess changes over time in biochemical, clinical, and patient/caregiver-reported outcomes in a representative population.No randomized studies have directly compared treatment with burosumab, a monoclonal antibody targeting FGF23, with oral phosphate and active vitamin D in adults with XLH. This three-year analysis included 109 adults enrolled in the XLH DMP: 54 who received burosumab and 55 who received Pi/D.This advertisement has not loaded yet, but your article continues below.“For people living with a rare, lifelong condition such as XLH, it is essential to understand how treatments perform over time,” said Angela Williams, PhD, Vice President, Global Head of Health Economics and Outcomes Research at Kyowa Kirin. “By following patients longitudinally and incorporating patient-reported measures, the XLH Disease Monitoring Program provides additional context for the clinical data supporting burosumab use in adults with XLH.”In addition to the XLH Disease Monitoring Program, Kyowa Kirin is advancing real-world insight generation through the International XLH Registry in Europe and the SUNFLOWER study in Japan and Korea.About CRYSVITA® (burosumab-twza) InjectionCRYSVITA is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, which binds to and inhibits the biological activity of FGF23, the underlying cause of hypophosphatemia in XLH. By blocking FGF23, CRYSVITA helps to restore phosphorus reabsorption in the kidneys and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.CRYSVITA is a fibroblast growth factor (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.Important Safety InformationCRYSVITA is contraindicated:In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.When serum phosphorus is within or above the normal range for age.In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment.Hyperphosphatemia and Risk of NephrocalcinosisIncreases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels.This advertisement has not loaded yet, but your article continues below.Increases in serum calcium have been reported in patients treated with CRYSVITA. Patients with risk factors such as pre-existing hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment, are at higher risk of hypercalcemia. Monitor these patients for serum calcium and parathyroid hormone levels before and during CRYSVITA treatment for moderate to severe hypercalcemia. In patients with moderate to severe hypercalcemia, CRYSVITA should not be administered until hypercalcemia is adequately managed.Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%).This advertisement has not loaded yet, but your article continues below.Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%).Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression.USE IN SPECIFIC POPULATIONSThere are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.PATIENT COUNSELING INFORMATIONAdvise patients not to use any oral phosphate and/or active vitamin D analog products.Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.For important risk and use information, please see the full Prescribing Information for CRYSVITA.About X-linked hypophosphatemia (XLH)X-linked hypophosphatemia is a rare, lifelong, genetic disease that can impact the bones and muscles in both children and adults. In individuals with XLH, the body doesn’t hold on to enough phosphorus, which is an essential mineral for bone health. This is due to the production of excess fibroblast growth factor 23 (FGF23), causing the body to release too much phosphorus through the urine. When phosphorus levels are too low (hypophosphatemia), it can cause the softening and weakening of growing bones in children (rickets) and of mature bones in adults (osteomalacia).1This advertisement has not loaded yet, but your article continues below.In children, XLH typically appears as bowed legs or knock knees. Over time, bone weakening can also lead to bone abnormalities in the legs, delayed growth, and short stature. In adults, XLH may cause osteomalacia, fractures and pseudo-fractures, and hypophosphatemia.1About the XLH Disease Monitoring Program The XLH DMP is an international, prospective, 10-year, longitudinal, observational study (NCT03651505) of adults and children with XLH in the US, Canada, and Latin America designed to characterize XLH disease presentation and progression, and prospectively assess changes over time in biochemical, clinical, and patient/caregiver-reported outcomes in a representative population. The program steering committee includes clinical experts in XLH, patient advocates from the XLH Network, and representatives from Kyowa Kirin and Ultragenyx Pharmaceutical.Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe.You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.comDahir K, et al. X-linked hypophosphatemia: a new era in management. J Endocr Soc. 2020;4(12):bvaa151.Contact: Susan Thiele Head of Therapeutic Communications, North America media.northamerica.bt@kyowakirin.comThis advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. 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