Thyrotropin alfa 900microgram powder for solution for injection vials

Introduction: Radioactive iodine (RAI) is commonly used in the management of differentiated thyroid cancers (DTCs). However, the long-term efficacy and the risk of tumor recurrence associated with it remain unclear. In particular, the comparison between recombinant human thyrotropin (rhTSH) and thyroid hormone withdrawal (THW) in terms of medium- and long-term recurrence rate in DTC patients has not been fully elucidated. Methods: A systematic search was carried out to identify articles comparing medium- and long-term outcomes (> 2 years) based on treatment with either rhTSH or THW. Ten studies, consisting of six randomized controlled trials (RCTs) and four retrospective studies with a total of 2,833 patients, were included in the analysis. Results: There was no significant difference in the medium- and long-term recurrence rates between the rhTSH group and the THW group. This was also the case in subgroup analyses of only RCTs or only retrospective studies. The structural incomplete response (SIR) rate was slightly higher in the rhTSH group, but a subgroup analysis of RCTs alone showed no significant difference in SIR between the two groups. Discussion: rhTSH is comparable to THW in achieving successful ablation of residual disease and maintaining low recurrence rates. However, further RCTs are required to investigate whether rhTSH can increase the risk of SIR.

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BACKGROUND: Thyroid gland dysfunction has been reported to occur with variable frequency during interferon alfa (IFN-alpha) therapy in patients with the hepatitis C virus (HCV). We prospectively evaluated if the prevalence of autoimmune thyroid disease in patients with HCV differs from that in patients with the hepatitis B virus (HBV) before, at the end of, and 6 months after stopping treatment with IFN-alpha. METHODS: One hundred thirty-four patients with HCV and 41 patients with HBV were studied. Measurements of serum free thyroxine, free triiodothyronine, thyrotropin, thyroid peroxidase antibodies (TPOAbs), thyroglobulin antibodies (TgAbs), and thyrotropin-binding inhibitory immunoglobulin were performed. RESULTS: Positive levels of TPOAb and TgAb were found in 20% and 11% of patients with HCV compared with 5% and 3% of patients with HBV, respectively. At the end of IFN-alpha therapy, thyroid gland dysfunction was more prevalent in patients with HCV (12%) compared with those with HBV (3%), with thyrotropin levels significantly higher in the HCV group (P = .03). Titers of TPOAb, TgAb, and thyrotropin-binding inhibitory immunoglobulin increased significantly (P = .02, P = .04, and P = .02, respectively) at the end of IFN-alpha therapy in patients with HCV but not in those with HBV. Patients who developed thyroid gland dysfunction were predominantly female (P = .03), had decreased levels of free triiodothyronine (P<.001), and had a higher prevalence of TPOAb (P = .03) before treatment with IFN-alpha. Thyroid gland dysfunction was reversed in 60% of those with HCV 6 months after discontinuing treatment with IFN-alpha. CONCLUSIONS: Patients with HCV are more susceptible than patients with HBV to autoimmune thyroid disease. Systematic screening of thyroid gland function and TPOAb titers in all patients with HCV before, during, and after IFN-alpha therapy appears warranted. This precaution is not necessary for patients with HBV.

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Papillary thyroid carcinoma (PTC) is the most common subtype of thyroid cancer (TC). Although surgery and radioactive iodine therapy (RAI) generally yield favorable outcomes, advanced cases with extensive local invasion and metastases pose significant challenges. We report the case of a 65-year-old male with advanced, inoperable PTC characterized by extensive local invasion and distant metastases. A whole-body radioiodine scan revealed no iodine-avid disease. However, following recombinant human thyrotropin (rhTSH) preparation, the patient developed severe compressive symptoms, necessitating glucocorticoid treatment. Lenvatinib monotherapy was initiated, resulting in initial symptom relief. Unfortunately, the disease rapidly progressed due to anaplastic transformation of the PTC, ultimately leading to the patient's death. This report highlights the challenges of managing advanced differentiated TC (DTC) and the risk of aggressive transformation into anaplastic TC (ATC), even with targeted therapy. It underscores the critical need for close monitoring and a multidisciplinary approach. Further research is needed to explore the role of targeted therapies, such as lenvatinib, in altering tumor biology and their long-term effects on disease progression.

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Background: Thyroid autoimmunity (TAI) has been widely associated with reduced fertility; however, its impact on assisted reproductive technology (ART) outcomes in euthyroid women remains controversial. Ovarian reserve (OR) and anti-Müllerian hormone (AMH) are considered to be the most reliable predictors of controlled ovarian hyperstimulation (COH) and ART outcome. This study aims to evaluate whether TAI affects COH outcomes depending on the OR, or if TAI is an independent negative factor affecting COH outcomes. Methods: This study includes 341 infertile euthyroid participants under 38 years old undergoing ART at a single reproductive medicine center. The serum concentrations of sex hormones, thyrotropin (TSH), AMH, and antithyroid antibodies (ATAbs) were measured before COH. Ovarian response to COH, assessed by oocyte number and maturation (percentage of mature MII oocytes), fertilization rate (FR), and early embryo development (cleavage and blastocyst rate), were assessed in 191 participants with TAI and 150 TAI negative age-matched controls with normal ORs. The TAI group was further divided into two subgroups: the TAI1 group with normal OR (n = 120) and the TAI2 group with diminished ORs (n = 71). Results: The mean of the retrieved oocytes was significantly lower in TAI1 (p = 0.015) and expectedly significantly lower in TAI2 (p &lt; 0.001) compared to the control. The percentage of MII oocytes was significantly lower in the TAI1 (p &lt; 0.001) and TAI2 (p = 0.009) groups compared to the control group. We observed significantly lower FR (p = 0.002), cleavage rate (p = 0.020), and blastocyst rate (p &lt; 0.001) in the TAI1 group compared to control. In the TAI2 group, there was a lower cleavage rate (p &lt; 0.001) and blastocyst rate (p &lt; 0.001) compared to the control. There was no difference in the mean percentage of MII oocytes, FR, and cleavage rate between the TAI1 and TAI2 groups, but the blastocyst rate was significantly lower (p &lt; 0.001) in the TAI2 group. Conclusions: TAI may represent a negative predictor of in vitro fertilization outcomes by impairing oocyte maturation, fertilization rate, and embryo development in ART cycles, regardless of ORs.

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Background/Objectives: Hypophosphatasemia (HPE) may be temporary (tHPE) in the context of severe diseases, such as sepsis or trauma, or it may persist (pHPE), indicating an adult form of hypophosphatasia (HPP; OMIM 171760), a rare metabolic bone disorder caused by pathogenic nucleotide variants (PNVs) in the ALPL gene. The aim of this study was to analyze the role of auxiliary general biomarkers in verifying low alkaline phosphatase (ALP) serum activity level as an alert parameter for PNVs in the ALPL gene, which are indicative of HPP. In this retrospective analysis, we examined adult patients with an ALP serum activity level below 21 U/L. The cohort comprised 88 patients with temporary HPE (tHPE group) and 20 patients with persistent HPE who underwent re-examination. Genetic analysis performed on 12 pHPE patients identified PNV in the ALPL gene in 11 cases (ALPL group). Hemoglobin [HB], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], calcium, phosphate, thyrotropin [TSH], albumin, total protein, and C-reactive protein [CRP] levels represented basic biomarkers. A comparative analysis between groups employed a Student’s t-test, and a Student’s t-test with bootstrap sampling (n = 10.000) was performed. Results: The mean HB, ALP, calcium, albumin, and total protein levels were lower in the tHPE group compared with the ALPL group (p &lt; 0.01). AST and CRP were increased in the tHPE group (p &lt; 0.01). The model showed an accuracy of 90% and an AUC of 0.94, which means that it can discern the two groups ~94% of the time. Conclusions: Basic biomarker evaluation effectively supports the interpretation of a decreased ALP serum activity level in the context of suspected HPP. In patients with laboratory HPE and biomarkers within reference, a PNV in the ALPL gene is highly suspected.

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PURPOSE: Thyroid hormone withdrawal (THW) in preparation for radioactive iodine therapy (RIT) may lead to hyponatremia and hyperkalemia because hypothyroidism reduces the glomerular filtration rate. Using recombinant human thyrotropin (rhTSH) may avoid these changes; however, these two preparation methods have not been compared in the literature. The purpose of this study was to reveal whether THW and rhTSH as preparation methods for RIT affect serum electrolytes differently. We also evaluated clinical factors influencing the onset of hyponatremia and hyperkalemia during RIT. MATERIALS AND METHODS: From April 2005 to December 2020, we analyzed 278 patients with thyroid cancer who received RIT. The patients were classified into two groups based on the preparation method, and renal function and serum electrolytes were compared between the groups. We also evaluated clinical factors that may affect overt hyponatremia (serum sodium level < 134 mmol/L) and hyperkalemia (serum potassium level ≥ 5.0 mmol/L). RESULTS: Serum sodium and chloride levels in the THW group were significantly lower than those in the rhTSH group (p < 0.001 and p = 0.002, respectively). In contrast, the serum potassium level in the THW group was significantly higher than that in the rhTSH group (p = 0.008). As for clinical factors that may influence hyponatremia, age and estimated glomerular filtration rate (eGFR) were significantly associated with serum sodium level in the univariate analysis (p = 0.033 and p = 0.006, respectively). In the multivariate analysis, only age was significantly associated with serum sodium level (p = 0.030). Regarding hyperkalemia, distant metastases, the preparation method and eGFR were significantly associated with the serum potassium level in the univariate analysis (p = 0.005, p = 0.005 and p = 0.001, respectively). In the multivariate analysis, only eGFR was significantly associated with hyperkalemia (p = 0.019). CONCLUSION: THW and rhTSH affect serum sodium and potassium levels differently. Renal function may be risk factors for hyperkalemia, whereas older age may be a risk factor for hyponatremia.

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