Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.

Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results.

Efficacy of secukinumab in Takayasu arteritis with myocardial infarction complicated with generalized pustular psoriasis: A case report.

Rationale: Takayasu arteritis (TAK) is an autoimmune disease that causes chronic inflammation targeting the aortic wall. Since many patients are resistant to steroid treatment, multiple immunosuppressants or interleukin-6 (IL-6) suppression therapy have served as treatment alternatives. However, there are very few reports on the effectiveness of biologics against inflammatory cytokines upstream of IL-6.

Successful treatment of anti-signal recognition particle antibody-positive myositis with intravenous cyclophosphamide: A case report.

Myositis-specific autoantibodies play an important role on the disease phenotype of idiopathic inflammatory myopathies (IIMs). Anti-signal recognition particle (SRP) antibody-positive patients with IIMs may present with severe myopathy and highly elevated serum creatine kinase levels. These patients are often resistant to immunosuppressive therapy, but there is no established treatment strategy.

Effects of canagliflozin on brain natriuretic peptide levels in patients with type 2 diabetes on peritoneal dialysis in Japan: protocol for a multicentre, prospective, randomised controlled trial (CARD-PD trial).

Introduction: Patients with type 2 diabetes (T2D) undergoing dialysis exhibit a higher mortality rate compared with those with other conditions, primarily due to vascular complications including coronary artery disease, heart failure and stroke. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, a type of drug for T2D, have reportedly decreased cardiovascular and renal events in patients with heart failure and chronic kidney disease, irrespective of diabetes presence. Nevertheless, the evidence supporting the use of SGLT2 inhibitors in patients undergoing dialysis has been limited.

Development of Chronic Thyroiditis During Cyclosporin A Treatment.

Cyclosporin A (CsA) is a calcineurin inhibitor used as an immunosuppressant. Although CsA effectively suppresses T cells, excessive suppression of regulatory T cells may exacerbate autoimmune diseases. Here, we report a case of chronic thyroiditis developing during CsA treatment.