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Publications

  1. Fujihara K, Sugita C, Yamashita K, Kamei Y. Assessing the benefits of “Circle”: A patient support program for neuromyelitis optica spectrum disorder for patients receiving satralizumab treatment. Clinical and Experimental Neuroimmunology. 2025;00:1–9. https://onlinelibrary.wiley.com/doi/10.1111/cen3.70037.  
  2. Murakami M, Okubo Y, Kobayashi S, Kikuta N, Ouchi Y, Shishido K, Terui T. Efficacy and safety of brodalumab in palmoplantar pustulosis: A 68-week randomized Phase 3 trial. Journal of the European Academy of Dermatology and Venereology. 2025:00:1-13. https://onlinelibrary.wiley.com/doi/10.1111/jdv.70156.  
  3. Tsuda S, Kunikata H, Hashimoto K, Asano T, Ito A, Kokubun T, Mitsuhide Y, Yasuda M, Nakazawa T. Safety and efficacy of orally administered SJP-0008 in central retinal artery occlusion: a phase IIa randomized clinical trial. Ophthalmology Science. 2025:100965. Article in Press. https://www.ophthalmologyscience.org/article/S2666-9145(25)00263-5/fulltext 
  4. Yamamura T, Isobe N, Kawachi I, Nohara C, Miyazaki Y, Tomita M, Kamei Y, Yamashita K, Nakahara J, Nakashima I, Fujihara K. Safety and effectiveness of Satralizumab in Japanese patients with neuromyelitis optica spectrum disorder: A 30‑month interim analysis of post‑marketing surveillance. Neurology and Therapy. 2025. Epub ahead of print. 
  5. Pal A, Pawar D, Sharma A. Faropenem for the management of infectious diseases – A systematic review of in vitro susceptibility tests and clinical studies. Journal of Laboratory Physicians. Article in Press. Faropenem for the management of infectious diseases – A systematic review of in vitro susceptibility tests and clinical studies – Journal of Laboratory Physicians
  6. Fukuoka H, Endo T, Tsuboi S, Fujio S. Prevalence and risk of complications in untreated patients with adult growth hormone deficiency. Pituitary. 2025;28:32. https://link.springer.com/article/10.1007/s11102-025-01500-9
  7. Chandorkar AB, Jhala D. Impact of trimetazidine on major adverse cardiac events in Asian patients with acute myocardial infarction: A systematic review. Asian J Cardiol Res. 2025;8 (1):124-32. https://journalajcr.com/index.php/AJCR/article/view/254
  8. Sonohata M, Kitamura M, Hashimoto A, Morioka Y. Prescription pattern of laxatives for opioid-induced constipation in Japanese patients with chronic non-cancer pain: A retrospective cohort study of a health insurance claims database. Cureus 2025;17(1): e78212. https://www.cureus.com/articles/308565-prescription-pattern-of-laxatives-for-opioid-induced-constipation-in-japanese-patients-with-chronic-non-cancer-pain-a-retrospective-cohort-study-of-a-health-insurance-claims-database#!/
  9. Ishibashi T, Tanioka H, Ikehara T, Kezbor S, Sonoyama T. Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity. Clin Drug Investig. 2025 Jan 20. Online ahead of print. https://link.springer.com/article/10.1007/s40261-024-01418-3
  10. Miyairi I, Miyazawa S, Takahashi Y, Kojima S, Kitanishi Y, Ogura E. Incidence of severe illness in pediatric influenza outpatients treated with baloxavir or neuraminidase inhibitors. J Infect Chemother. 2025;31(3):102606. Online ahead of print. https://www.sciencedirect.com/science/article/pii/S1341321X25000029#ack0010
  11. Yoshida M, Taguchi N, Piao Y, Gupta R, Berry M, Peters J, Abdelghany M, Chiang M, Wang C, Yotsuyanagi H. Treatment pattern and clinical outcomes of remdesivir in hospitalized COVID-19 patients with severe chronic kidney disease: a database analysis of acute care hospitals in Japan. Clin Exp Nephrol. 2024. Online ahead of print. https://link.springer.com/article/10.1007/s10157-024-02609-0
  12. Nakayama T, Xu L, Muramatsu Y. CDK4/6 inhibitor plus endocrine therapy for advanced breast cancer: results from a web-based survey in Japan. Future Oncol. 2024 Dec 20. Online ahead of print. https://www.tandfonline.com/doi/citedby/10.1080/14796694.2024.2441649?scroll=top&needAccess=true
  13. Tsubouchi K, Arima H, Emoto T, Nakazawa H, Kitano T, Mikami M, Aoyagi C, Matsuzaki H, Tominaga K, Gunge N, Miyazaki T, Okabe Y, Nakamura N, Fukuhara Y, Tachibana M, Nakagawa C, Yamazaki F, Haga N. Clinical Features and Current Pharmacotherapy of OAB in Practice: Ideal and Reality. Adv Ther. 2024 Dec 24. Online ahead of print. https://link.springer.com/article/10.1007/s12325-024-03070-x
  14. Takizawa T, Kitano T, Togo K, Yoshikawa R, Iijima M. Clinical practice for migraine treatment and characteristics of medical facilities and physicians treating migraine: Insights from a retrospective cohort study using a Japanese claims database. PLoS ONE. 2024;19(12): e0315610. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0315610
  15. Thanawala S, Abiraamasundari R, Shah R. Comparative Pharmacokinetics of Sustained-Release versus Immediate-Release Melatonin Capsules in Fasting Healthy Adults: A Randomized, Open-Label, Cross-Over Study. Pharmaceutics. 2024 Sep 25;16(10):1248. https://www.mdpi.com/1999-4923/16/10/1248
  16. Goi N, Iwata F, Sugihara Y, Higa S, Chikama T. An Open-Label, Phase III Study to Assess the Efficacy and Safety of Cysteamine Ophthalmic Solution 0.55% in Japanese Cystinosis Patients. Clin Ophthalmol. 2024;18: 3457-3471. https://www.dovepress.com/article/download/97675 
  17. Takagi T, Xu L, Hoshi M, Arai S. Identifying Risk Factors of Major Adverse Cardiac Events in Patients With Ulcerative Colitis: A Retrospective Japanese Claims Data Analysis. J Gastroenterol Hepatol. 2024; Epub ahead of print. https://onlinelibrary.wiley.com/doi/10.1111/jgh.16831
  18. Ota T, Kuratani S, Masaki H, Ishizaki S, Seki H, Takebe T. Impact of chronic constipation symptoms on work productivity and daily activity: a large-scale internet survey. JGH Open. 2024;8:e70042. https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70042
  19. Okubo Y, Kobayashi S, Murakami M, Sano S, Kikuta N, Ouchi Y, Terui T. Authors’ Reply to Wang et al., “Comment on ‘Efficacy and Safety of Brodalumab, an Anti‑interleukin‑17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16‑Week Results of a Randomized Clinical Trial’ “. American Journal of Clinical Dermatology. 2024;25(6):1025-1027. https://link.springer.com/content/pdf/10.1007/s40257-024-00896-7.pdf
  20. Kessoku T, Akamatsu T, Morioka Y, Yokota T, Kobayashi M, Uchida K, Koretaka Y, Nakajima A. Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials. Japanese Journal of Clinical Oncology. 2024:hyae135. https://academic.oup.com/jjco/advance-article-pdf/doi/10.1093/jjco/hyae135/59482395/hyae135.pdf
  21. Kitamura M, Morioka Y, Kobayashi M, Ushida T. A web–based survey on the quality of life of patients with opioid induced constipation using weak opioids in chronic non–cancer musculoskeletal pain in Japan. Pain Research. 2024;39(1): 64-75. https://www.jstage.jst.go.jp/article/pain/39/1/39_64/_pdf/-char/ja
  22. Yamamura T, Isobe N, Kawachi I, Nohara C, Miyazaki Y, Tomita M, Tsumuraya T, Yamashita K, Nakahara J, Nakashima I, Fujihara K. Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 6-month Interim Analysis of Post-marketing Surveillance. Neurology and Therapy. 2024;13(5):1361-1383. https://link.springer.com/content/pdf/10.1007/s40120-024-00640-7.pdf
  23. Moribe T, Xu L, Take K, Yonemoto N, Suzuki K. Real-world treatment trends and triple class exposed status in newly diagnosed multiple myeloma patients in Japan: a retrospective claims database study. PLoS One. 2024;19(9):e0310333. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0310333
  24. Okubo Y, Kobayashi S, Murakami M, Sano S, Kikuta N, Ouchi Y, Terui T. Efficacy and Safety of Brodalumab, an Anti-interleukin-17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16-Week Results of a Randomized Clinical Trial. American Journal of Clinical Dermatology. 2024;25(5):837-847. https://link.springer.com/content/pdf/10.1007/s40257-024-00876-x.pdf
  25. Bando H, Kotani D, Satake H, Hamaguchi T, Shiozawa M, Kotaka M, Masuishi T, Yasui H, Kagawa Y, Komatsu Y, Oki E, Yamamoto Y, Kawakami H, Misumi T, Taniguchi H, Yamazaki K, Muro K, Yoshino T, Kato T, Tsuji A. QUATTRO-II randomized trial: CAPOXIRI+bevacizumab vs. FOLFOXIRI+bevacizumab as first-line treatment in patients with mCRC. Med. 2024;5(9):1164-1177.e3. https://www.cell.com/med/fulltext/S2666-6340(24)00216-2
  26. Yoshinami T, Nagai SE, Hattori M, Okamura T, Watanabe K, Nakayama T, Masuda H, Tsuneizumi M, Takabatake D, Harao M, Yoshino H, Mori N, Yasojima H, Oshiro C, Iwase M, Yamaguchi M, Sangai T, Kosaka N, Tajima K, Masuda N. Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-line setting: an observational study. Breast Cancer 2024;31:621-632. https://link.springer.com/content/pdf/10.1007/s12282-024-01575-5.pdf
  27. Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in Japan: A General Population Survey. Neuropsychiatric Disease and Treatment. 2024;20:1355-1366. https://www.dovepress.com/article/download/93865
  28. Dinh Thiem V, Van Anh PT, Van Men C, Hung DT, Pollard AJ, Kamitani A, Tada Y, Fukuyama H, Iwasaki Y, Ariyasu M, Sonoyama T. A SARS-CoV-2 recombinant spike protein vaccine (S-268019-b) for COVID-19 prevention during the Omicron-dominant period: A phase 3, randomised, placebo-controlled clinical trial. Vaccine. 2024;42(17):3699-3709. https://www.sciencedirect.com/science/article/pii/S0264410X24005231
  29. LoPresti M, Igarashi A, Sonohara Y, Bowditch S. A quantitative cross-sectional study of the burden of caring for patients with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex-associated epilepsy in Japan. Epilepsy and Behavior. 2024;154:109741. https://www.epilepsybehavior.com/article/S1525-5050(24)00122-7/fulltext
  30. Nomoto K, Takashio O, Matsuyama S, Higa S, Otsubo T. Diagnosis and Treatment of Generalized Anxiety Disorder in Japan: Psychiatric Specialist Survey. Neuropsychiatric Disease and Treatment. 2024;20:1001-1010. https://www.dovepress.com/article/download/92633
  31. Iwata S, Pollard AJ, Tada Y, Omoto S, Shibata RY, Igarashi K, Hasegawa T, Ariyasu M, Sonoyama T. A phase 3 randomized controlled trial of a COVID-19 recombinant vaccine S-268019-b versus ChAdOx1 nCoV-19 in Japanese adults. Scientific Reports. 2024;14(1):9830. https://www.nature.com/articles/s41598-024-57308-3
  32. Nair T, Ray S, George J, Pande A. Efficacy of Trimetazidine in the Prevention of Contrast-Induced Nephropathy in Patients Undergoing Contrast Coronary Intervention: A Systematic Review and Meta-Analysis (PRISMA). Journal of Clinical Medicine. 2024;13(7):2151. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11012740/pdf/jcm-13-02151.pdf
  33. Goto H, Sugita J, Hasegawa Y, Hayasaka K, Sunagoya K, Hatase R, Nishida M, Ichihashi Y, Odera M, Senjo H, Yokoyama S, Ara T, Shiratori S, Endo T, Hino M, Maeda Y, Sawa M, Sato N, Teshima T. Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study. Transplantation. 2024;108(4):996-1003. https://pmc.ncbi.nlm.nih.gov/articles/PMC10962423/pdf/tpa-108-996.pdf
  34. Kessoku T, Higashibata T, Morioka Y, Naya N, Koretaka Y, Ichikawa Y, Hisanaga T, Nakajima A. Naldemedine and Magnesium Oxide as First-Line Medications for Opioid-Induced Constipation: A Comparative Database Study in Japanese Patients With Cancer Pain. Cureus. 2024;16(3):e55925. https://pmc.ncbi.nlm.nih.gov/articles/PMC11004843/pdf/cureus-0016-00000055925.pdf
  35. Takizawa T, Kitano T, Iijima M, Togo K, Yonemoto N. Treatment patterns and characteristics of patients with migraine: results from a retrospective database study in Japan. The Journal of Headache and Pain. 2024;25(1):19. https://thejournalofheadacheandpain.biomedcentral.com/counter/pdf/10.1186/s10194-024-01722-5.pdf
  36. Nakashima I, Nakahara J, Yasunaga H, Yamashita M, Nishijima N, Satomura A, Nio M, Fujihara K. Real-world management of patients with neuromyelitis optica spectrum disorder using satralizumab: Results from a Japanese claims database. Multiple Sclerosis and Related Disorders. 2024;84:105502. https://www.msard-journal.com/article/S2211-0348(24)00081-6/fulltext
  37. Tahara S, Otsuka F, Endo T. Recognition and Practice of Hypopituitarism After Traumatic Brain Injury and Subarachnoid Hemorrhage in Japan: A Survey. Neurology and Therapy 2024;13(1):39-51. https://link.springer.com/content/pdf/10.1007/s40120-023-00553-x.pdf
  38. Morizane, C., Ueno, M., Ikeda, M. et al. A Phase 2 study of nivolumab in combination with modified FOLFIRINOX for metastatic pancreatic cancer. BJC Reports 2024;2:Article number 3. https://www.nature.com/articles/s44276-023-00028-4.pdf
  39. Izumi N, Kitta T, Mitsui T. Importance of Regular Examination and Follow-up in Pediatric Patients with Neurogenic Bladder: 24-Month Follow-up Study Using a Japanese Health Insurance Database. Advances in Therapy. 2023;40(12):5519-5535.https://link.springer.com/content/pdf/10.1007/s12325-023-02692-x.pdf
  40. Shimizu R, Sonoyama T, Fukuhara T, Kuwata A, Matsuo Y, Kubota R. A Phase 1 Study of Ensitrelvir Fumaric Acid Tablets Evaluating the Safety, Pharmacokinetics and Food Effect in Healthy Adult Populations. Clinical Drug Investigation. 2023;43(10):785-797. https://link.springer.com/content/pdf/10.1007/s40261-023-01309-z.pdf
  41. Sato S, Tomitori H, Okawa A, Akano K. Prescription patterns of analgesics in cancer patients with bone metastases in Japan: a retrospective database study. International Journal of Clinical Oncology. 2023;28(9):1227-1235. https://pubmed.ncbi.nlm.nih.gov/37314600/
  42. Sonoyama T, Kamitani A, Shibata RY, Seki NM, Omoto S, Igarashi K, Ariyasu M. Safety and immunogenicity of a booster dose of S-268019-b: Interim findings of a Phase 3, open-label clinical study in Japan. Vaccine X. 2023;15:100390. https://pmc.ncbi.nlm.nih.gov/articles/PMC10562875/pdf/main.pdf
  43. Igarashi A, Togo K, Kobayashi Y, Kamei K, Yonemoto N, Ishiwada N. Inpatient and outpatient costs associated with respiratory syncytial virus in Japanese infants and older adults. Future Virology. 2023;18(10): 643–657. https://www.tandfonline.com/doi/epdf/10.2217/fvl-2023-0069?needAccess=true
  44. Uchino Y, Uchino M, Mizuno M, Shigeno Y, Furihata K, Shimazaki J.
    Morphological alterations in corneal nerves of patients with dry eye and associated biomarkers. Experimental Eye Research. 2023;230:109438. https://pubmed.ncbi.nlm.nih.gov/36933693/
  45. Shimizu R, Sonoyama T, Fukuhara T, Kuwata A, Matsuzaki T, Matsuo Y, Kubota R. Evaluation of the Drug-Drug Interaction Potential of Ensitrelvir Fumaric Acid with Cytochrome P450 3A Substrates in Healthy Japanese Adults. Clinical Drug Investigation. 2023;43(5):335-346. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10177727/pdf/40261_2023_Article_1265.pdf
  46. Kitta T, Mitsui T, Izumi N. Diagnosis and Treatment of Japanese Children with Neurogenic Bladder: Analysis of Data from a National Health Insurance Database. Journal of Clinical Medicine. 2023;12(9):3191. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10179246/pdf/jcm-12-03191.pdf
  47. Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y.
    First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus. 2023;20(2):291-301. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10024660/pdf/10388_2022_Article_970.pdf
  48. Sonoyama T, Iwata S, Shinkai M, Iwata-Yoshikawa N, Shiwa-Sudo N, Hemmi T, Ainai A, Nagata N, Matsunaga N, Tada Y, Homma T, Omoto S, Yokokawa Shibata R, Igarashi K, Suzuki T, Hasegawa H, Ariyasu M. Results from a preclinical study in rodents and a Phase 1/2, randomized, double-blind, placebo-controlled, parallel-group study of COVID-19 vaccine S-268019-a in Japanese adults. Vaccine. 2023;41(11):1834-1847. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9755034/pdf/main.pdf
  49. Shimizu R, Sonoyama T, Fukuhara T, Kuwata A, Matsuo Y, Kubota R.
    Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults. Antimicrobial Agents and Chemotherapy. 2022;66(10):e0063222. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9578392/pdf/aac.00632-22.pdf
  50. Miyazawa S, Takazono T, Hosogaya N, Yamamoto K, Watanabe H, Fujiwara M, Fujita S, Mukae H. Comparison of intra-familial transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using an influenza transmission model and a health insurance claims database. Clinical Infectious Diseases. 2022;75(6):927-935. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9522426/pdf/ciac068.pdf
  51. Sonohata M, Wada S, Koretaka Y, Morioka Y, Mishima H, Mawatari M.
    A Survey of the Incidence of Constipation in Patients with Chronic Non-cancer Pain Using Opioid Analgesics in Japan. Pain and Therapy. 2022;11(3):845-859. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314494/pdf/40122_2022_Article_392.pdf
  52. Shinkai M, Sonoyama T, Kamitani A, Shibata RY, Seki NM, Omoto S, Shinoda M, Sato T, Ishii N, Igarashi K, Ariyasu M. Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study. Vaccine. 2022;40(32):4328-4333. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9212435/pdf/main.pdf
  53. Iwata S, Sonoyama T, Kamitani A, Shibata R, Homma T, Omoto S, Igarashi K, Ariyasu M.
    Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings. Vaccine. 2022;40(27):3721-3726. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122779/pdf/main.pdf
  54. Takeuchi Y, Saito H, Makishima M, Yokoyama H, Yamaguchi T, Fujii H, Inoue E, Isemura T, Kondo S. Long-term safety of eldecalcitol in Japanese patients with osteoporosis: a retrospective, large-scale database study. Journal of Bone and Mineral Metabolism. 2022;40(2):275-291. https://pubmed.ncbi.nlm.nih.gov/35041084/
  55. Meng F, Li W, Zhi F, Li Z, Xue Z, He S, Chen W, Chen Y, Xing X, Yao C, Wu Y, Zhang S.
    Antiperistaltic effect and safety of l-menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double-blind, placebo-controlled study. Digestive Endoscopy. 2021;33(7):1110-1119. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596731/pdf/DEN-33-1110.pdf