bluuebunny/crossref_metadata_2025_split huggingface dataset:
OR29-5 Phase 3 PaTHway Trial: Participants Treated With TransCon PTH Achieved Independence From Conventional Therapy While Maintaining Normal Serum Calcium
Authors: Khan Aliya 
Published: November 2022

Abstract

Background
Adults with chronic hypoparathyroidism managed with conventional therapy (calcitriol, alfacalcidol, and oral calcium) generally report a reduced quality of life (QoL) and remain at risk for long-term complications from abnormal calcium and phosphate metabolism. The PaTHway trial assessed the efficacy and safety of TransCon PTH at Week 26.

Methods
PaTHway was a double-blind, placebo-controlled 26-week trial with 3: 1 randomization to TransCon PTH 18 mcg/d or placebo, co-administered with conventional therapy. The composite primary efficacy endpoint was the proportion of participants at Week 26 who achieved: serum calcium levels in the normal range (8.3–10.6 mg/dL), independence from conventional therapy defined as requiring no active vitamin D and ≤600 mg/day of calcium supplementation, and no increase in prescribed study drug over 4 weeks prior to Week 26. Key secondary endpoints included Hypoparathyroidism Patient Experience Scale (HPES) domain scores and 36-Item Short Form Survey (SF-36) subscale scores.

Results
82 participants were dosed (78% female, mean age 49 years). 79 completed treatment through Week 26. 79% (48/61) of participants randomized to TransCon PTH met the composite primary efficacy endpoint, compared to 5% (1/21) in the placebo group (p &lt;0.0001). 93% (57/61) participants treated with TransCon PTH achieved independence from conventional therapy. At baseline, mean serum calcium was 8.8 and 8.7 mg/dL for TransCon PTH and placebo respectively; 8.9 mg/dL and 8.2 mg/dL at Week 26, respectively. For TransCon PTH, mean urine calcium decreased significantly from 390 mg/24-hour at baseline to 220 mg/24-hour (normal range &lt;250 mg/24-hour) at Week 26 compared to 329 mg/24-hour at baseline to 292 mg/24-hour at Week 26 for placebo. TransCon PTH therapy demonstrated a significant improvement in HPES-Symptom domain scores − Physical (p = 0.0038) and Cognitive (p = 0.0055), HPES-Impact domain scores − Physical Functioning (p = 0.0046) and Daily Life (p = 0.0061), and SF-36 Physical Functioning subscale score (p = 0.0347) compared to placebo. Overall, TransCon PTH was well-tolerated. The majority of adverse events (AE) were mild or moderate in severity. The most commonly reported study drug-related AEs were injection site reactions, hypercalcemia, and headaches. No study drug-related AEs led to withdrawal from the study.

Conclusions
In the PaTHway phase 3 trial, 79% of participants on TransCon PTH therapy (versus 5% on placebo) were able to achieve independence from conventional therapy while maintaining normocalcemia at Week 26. Uniquely, TransCon PTH therapy decreased and normalized 24-hour urine calcium excretion and significantly improved QoL (symptom burden and impact) from baseline compared to placebo. These data suggest the potential for TransCon PTH to improve clinical outcomes and QoL compared to current conventional therapy.
Presentation: Tuesday, June 14, 2022 10:45 a.m. - 11:00 a.m.
PSAT251 Examination of TRH test in Central Hypothyroidism due to Non-Functional Pituitary Adenoma
Authors: Buyandalai Battsetseg , Takamizawa Tetsuya , Horiguchi Kazuhiko , Yoshioka Masayuki , Nishikido Ayaka , Toki Akiko , Ishida Emi , Yoshino Satoshi , Matsumoto Shunichi , Yamada Eijiro , Ozawa Atsushi , Yamaguchi Rei , Tosaka Masahiko , Yamada Shozo , Yamada Masanobu 
Published: November 2022

Abstract

Objectives
There is a little evidence for the TRH test criteria in the diagnosis of Central Hypothyroidism (CeH). Therefore, we investigated the significance of the TRH test for Central Hypothyroidism due to Non-Functional Pituitary Adenoma.

Methods
107 cases of Non-functional pituitary adenoma (NFPA) in Gunma University Hospital Neurosurgery and Toranomon Hospital Intercerebral Pituitary Surgery, between 2007 to 2020 are studied. Subjects divided into CeH group (n = 19) with FT4 below the reference value and a normal group (n = 88). Serum TSH level was determined before (basal-TSH value) and 30, 60, 120 minutes after TRH administration. Peak-TSH value, delayed and prolonged responses were analyzed. A peak-TSH occurring at 60 minutes or later was considered as a delayed response. If 120-minutes TSH value to peak-TSH value ratio is equal to or higher than 0.6 was considered as a prolonged response.

Results
The basal-TSH was higher in the CeH group than in the normal group (median 2.7 vs. 1.5μIU/mL) (p &lt;0.01). There was no difference between two groups, in both 30-minute value and the peak value. Delayed response occurred in 10/19 (53%) in the CeH group, and 18/88 (20%) in the normal group (p &lt; 0.01). Prolonged response occurred at a higher rate of 15/19 (79%) in the CeH group, while in 23/88 (26%) in the normal group (p &lt;0.01). AUC was maximum when prolonged response (120-minute value to peak value ratio) is equal to or lower than 0.65.

Conclusion
In central hypothyroidism due to Non-Functional Pituitary Adenoma, the basal-TSH value does not usually decrease, but rather be higher value within the reference range. 30-minute value or peak value was not useful in diagnosis, yet the prolonged response was more significant. Central Hypothyroidism in Non-Functional Pituitary Adenoma, can be diagnosed with sensitivity of 79% and specificity of 78% when the 120-minute value to peak value ratio is equal to or lower than 0.65.
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.
PSAT295 Low Grade B-CELL Lymphoma and Follicular Cancer in a Patient with Hashimoto's Thyroiditis Presenting as Two Different Thyroid Nodules
Authors: Puchalski Adam , Hodge Marybeth 
Published: November 2022

Abstract
We present an 88 year old female with a history of hypothyroidism due to Hashimoto's thyroiditis who noted a lump in the left side of her neck. Thyroid ultrasound revealed multiple nodules throughout the thyroid gland. The right lobe contained a 4.3 cm solid, dominant nodule and the left lobe contained a 4.2 cm lobulated hyperechoic nodule.
Ultrasound-guided fine-needle aspiration biopsy of the 4.3 cm right thyroid nodule revealed follicular lesion of undetermined significance with predominantly Hurthle cells. Thyroseq was positive for aTERT and EIF1AX mutations. Ultrasound-guided fine-needle aspiration biopsy of the 4.2 cm left thyroid nodule revealed malignant cells consistent with a low-grade B-cell lymphoma.
She underwent a total thyroidectomy. The final pathology report revealed both a 5.5 cm follicular carcinoma in the right lobe and a low-grade B-cell lymphoma most compatible with extra nodal marginal zone lymphoma of the mucosa associated lymphoid tissue (MALT lymphoma) involving predominantly the left lobe of the thyroid.
She is beginning radiation treatment for the lymphoma. Three months after radiation treatment is completed, she will undergo radioactive iodine treatment for the follicular carcinoma.
Thyroid cancer is the most common endocrine malignancy. However, the thyroid is an uncommon site of cancer overall, accounting for only 1.5% to 4.7% of new cancer cases in the general population of the United States. Malignant lymphoma presenting as a primary neoplasm in the thyroid is even more uncommon and represents only 1 to 5% of all thyroid malignancies. Hashimoto's thyroiditis is a known risk factor for MALT lymphoma. However, there is no known association between Hashimoto's thyroiditis and follicular carcinoma. There are several reports of patients with presence of both papillary thyroid cancer and MALT lymphoma. One case was reported of simultaneous MALT lymphoma and medullary thyroid cancer. This is the first case of a patient with both follicular thyroid cancer and MALT lymphoma in the thyroid gland.
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.
PSAT317 An Impending Thyroid Storm Caused by COVID-19 Infection
Authors: Ahmed Ammar , Biswas Suman , Tan Zi 
Published: November 2022

Abstract

Background
Thyroid storm is an acute, potentially fatal complication of hyperthyroidism, usually manifested with tachycardia, hyperthermia, and altered mental status. Despite medical advancements, the mortality associated with thyroid storms remained 5% to 25%. Previously, cases of thyroiditis following COVID-19 infection have been reported. But the manifestation of COVID-19 infection as a thyroid storm is infrequent, and less than 5 cases have been reported to date.

Case
A 72-year-old female with a remote history of breast cancer status post-mastectomy presented to the emergency department with the chief complaint of shortness of breath. She was found to have a history of fever eight days before the presentation; she was also complaining of non-productive cough, non-bloody, and non- bilious vomiting, myalgia, and fatigue. Home Covid Test was positive. On the day of the presentation, she received Regeneron infusion (casirivimab and imdevimab) and was discharged home. After a few hours, she represented to the hospital with chills and worsening of shortness of breath. She was found to be hypoxic on the presentation, was started on O2 supply, and transferred to the ICU. She received IV dexamethasone 6 mg and IV Remdesivir 200 mg on the first day, followed by 100mg for the next four days. On the fourth day following admission, she developed Atrial Fibrillation with a rapid ventricular response. The patient was somnolent and had loose bowel movements. Thyroid function tests were ordered; TSH was 0.02 and free T4 of 2.9. She stated she was never diagnosed with a thyroid disorder in the past. Thyroid function tests were ordered, which are mentioned in the table below. A thyroid-stimulating antibody assay was ordered to rule out Graves thyrotoxicosis, which turned out to be normal. Ultrasound of the thyroid gland didn't reveal any abnormalities.

Conclusion
Although most patients remain euthyroid during COVID-19 infection, some may have shown transient thyroid derangements during the illness, which later turns out to be normal. Our case shows that a clinician should not take the thyroid derangements in COVID-19 lightly, as they can be the early signs of an impending thyroid storm. Our case guides the clinician to evaluate the thyroid function as soon as possible in any signs of overt hyperthyroidism. Due to the high mortality associated with thyroid storm, a clinician should have a high index of suspicion to diagnose the storm, such as in our case where other signs of hyperthyroidism are absent. Early treatment of thyroid storms becomes necessary to mitigate the mortality in such cases.
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.
PSAT347 New Onset of Graves’ Disease after COVID-19 Vaccination
Authors: Anto Antony Mc , Joglekar Mansi , Kurian Roshini , Kant Ravi , Verma Vipin , Chandra Lakshya 
Published: November 2022

Abstract

Introduction
Adjuvants are substances that are commonly found in vaccines. They can enhance the efficacy and potency of a vaccine via an immunological response. However, in some susceptible individuals, these adjuvants can lead to a serious autoimmune response known as autoimmune/inflammatory syndrome induced by adjuvants (ASIA). This can lead to the onset of autoimmune disorders following vaccination. There are many case reports of the onset of autoimmune disorders following COVID-19 vaccination. However, new onset of Graves’ disease within one day after COVID-19 vaccination, is of rare occurrence.

Clinical Case
We present the case of a 33-year-old Caucasian male who presented to his primary care physician with chief complaints of fever ranging between 99.2F to 101.3F, palpitations and hand tremors which started one day after he received his first dose of COVID-19 vaccine. Initial laboratory evaluation included a negative throat swab for Group A Streptococcus, a negative nasal swab for Influenza A & Influenza B and a negative nasopharyngeal swab for SARS-COV-2 RNA. On physical examination, he was afebrile, pulse rate 101/min, blood pressure 125/74 mm Hg and oxygen saturation 98%. Due to persistence of tachycardia, an EKG was done which showed a normal sinus rhythm with no other abnormalities. Further laboratory testing was remarkable for a suppressed TSH 0.005 (0.300-4.00 uUI/ml), elevated FT4 2.36 (0.80-1.80 ng/dl) and an elevated TSH receptor Antibody (TRAb) 8.67 (0.00-1.75 IU/L), which confirmed the diagnosis of Graves’ disease. Subsequently, patient established care at our endocrinology clinic. Labs were repeated which showed persistence of hyperthyroidism with TSH &lt;0.005, high normal FT4 1.56 and an elevated FT3 5.36 (2.00-4.40 pg/ml). Thyroid ultrasound was remarkable for mild thyromegaly with increased vascularity and no discrete nodules. Patient was initiated on Methimazole 10 mg daily and propranolol 10 mg twice daily. During the first follow-up visit, the dose of Methimazole was reduced to 5 mg daily based on improved labs. However, it had to be increased back to 10 mg daily due to subsequent worsening of labs. Since then, patient has been maintained on a stable dose of Methimazole 10 mg once daily and the beta-blocker has been discontinued. It has been almost 1 year since the diagnosis and the Graves’ disease specific Thyroid Stimulating Immunoglobulin (TSI) antibody is still elevated at 1.31 (0.00-0.55 IU/L).

Conclusion
Graves’ disease should be considered high in the differential diagnosis in a patient presenting with fever and tachycardia following COVID-19 vaccination. Our unique case supports the current literature available on the various autoimmune conditions caused by the autoimmune/inflammatory syndrome induced by adjuvants, also known as ASIA.
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m., Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.
PSAT350 Autoimmune Polyglandular Syndrome Type II Presenting with Hashimoto's Thyroiditis, Diabetes Mellitus Type I and Addison's Disease: A Case Report
Authors: Barjose Angelie Rose , Barrera Jerome , Yumol Daniel Mark , Caluscusin Ivan Rommel 
Published: November 2022

Abstract
A. BACKGROUND/SIGNIFICANCE Autoimmune polyglandular syndrome Type II (APS-II) is a rare polyendocrinopathy with a prevalence of 1 to 2 in 100,000, instigated by immune-mediated destruction of several organs. Knowledge of APS-II is crucial, especially in the early detection of polyglandular disorder among patients with endocrine autoimmunity.
B. CASE This case is of a 40-year-old male who initially presented with Grave's disease after showing signs and symptoms of hyperthyroidism, as supported by low thyrotropin (&lt;0.05 uIU/mL; nv: 0.35-4.94) and high free thyroxine levels (2.05 ng/dL, nv: 0.71-1.85). He was maintained on methimazole.
Five months following diagnosis, he developed symptoms of Diabetes Mellitus Type 1 (T1DM) as confirmed by high capillary blood glucose, undetectable C-peptide, and positive anti-Glutamic acid decarboxylase. Insulin and rosuvastatin were added on his maintenance medications. Ten months later, he discontinued methimazole and became lost to follow-up. One month after discontinuation, he sought consult again after experiencing symptoms of fatigue, muscle cramps, cold intolerance, forgetfulness, abdominal pain, diarrhea, and episodes of hypoglycemia at home. On examination, he was noted to have hypotension of 80/60 mmHg and skin hyperpigmentation. His random blood sugar was 408 mg/dL. High thyrotropin (57.8777 uIU/Ml, nv: 0.35-4.94), low free thyroxine (0.57 ng/dL, nv: 0.71-1.85), and positive antithyroid peroxidase antibody levels revealed Hashimoto's thyroiditis. Low fasting 8 am serum cortisol (81 nmol/L, nv: 138-635) and low serum cortisol 30 mins (403.85 nmol/L) and 1 hour (542.31 nmol/L, normal response: &gt;550 nmol/L) after adrenocorticotropic hormone stimulation test in addition to the clinical manifestations, supported the diagnosis of Addison's disease.
With the combination of Addison's disease, Autoimmune thyroid disease, and T1DM, a diagnosis of APS Type II was made. Management included insulin, prednisone, and levothyroxine. These resulted in significant improvement in the patient's symptoms. He is now clinically well and compliant to regular follow-up.
C. LEARNING POINTS/CONCLUSION It is crucial in APS-II management to identify and manage the associated autoimmune disorders to prevent significant morbidity and mortality. Therefore, in the presence of any autoimmune disorder, a high index of suspicion for APS-II is essential. There should be regular follow-up and observation of patients with autoimmune endocrine disorders to ensure early detection of APS-II. Patient health education must include identifying symptoms of the disorders for which they are at high risk.
Keywords: APS Type 2, Addison's Disease, DM Type 1, Hashimoto's Thyroiditis
Sources of Support: None
Conflicts of Interest: None
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.
PSAT353 Can Generalized Granuloma Annulare occur in patients with Graves’ disease?
Authors: Elshimy Ghada , Raj Rishi 
Published: November 2022

Abstract

Introduction
Granuloma annulare (GA) is a benign self-limiting dermatosis, typically characterized by an annular arrangement of erythematous or flesh-colored papules, affecting patients of all ages. An association between GA and autoimmune diseases (including autoimmune thyroiditis) has been reported in the literature thus suggesting that GA belongs to the spectrum of autoimmune diseases. However, only a few case reports described the unusual association of localized GA with hyperthyroidism. The definitive correlation between thyroid disease and GA hasn't been established. It was suggested that there is a common immunogenic predisposition or that both diseases share a common pathway. We present a rare case of generalized granuloma annulare in a patient with Graves’ disease.

Case report
A 52-year-old African American female with a past medical history of Graves’ disease with mild Graves’ ophthalmopathy was referred to the endocrinology clinic. She was diagnosed with Graves’ disease seven years ago and was medically managed ever since. Initially, she was treated with a high dose of methimazole however, for the past six years, she was on a stable dose of methimazole 5 mg daily. Two years following diagnosis of Graves’ disease, she developed serpiginous non-pruritic erythematous skin papules and patches in the right upper arm which slowly progressed over the course of years to involve bilateral inner thighs and under the breasts. She was evaluated by dermatology at that time and was empirically treated with a topical antifungal agent without any significant improvements. After establishing care with us, there was suspicion of methimazole-induced ANCA vasculitis or other autoimmune diseases. Extensive rheumatological workup including ANCA level was performed with negative results. Since her thyroid function tests (TSH and free T4) were normal on a low dose of methimazole for an extended period, we discontinued methimazole, however, skin rash didn't improve. The patient was then evaluated by dermatology and was diagnosed with GA based on clinical judgment. She was subsequently treated with an extended course of triple antibiotics therapy using rifampin, ofloxacin, and minocycline for 5 months with significant improvement of the skin rash. Currently, the patient has been off methimazole for 12 months and off triple antibiotic for 4 months with no recurrence of symptoms.

Conclusion
Although rare, generalized granuloma annulare can be seen in patients with autoimmune thyroid disease including Graves’ disease. Hence, endocrinologists should be aware of the different skin manifestations which can be seen in patients with autoimmune thyroid disease. Further studies are necessary to clarify the association of GA with autoimmune thyroid disease.
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.
PSAT357 Preventing Progression of Ophthalmopathy Using a 'Block-Replace' Treatment Strategy in Labile Graves’ Disease
Authors: Bauer Jessica , Riordan Marianne , Panvelker Samir 
Published: November 2022

Abstract

Introduction
Graves’ disease is an autoimmune disorder that most commonly causes hyperthyroidism. Pathogenesis usually involves the stimulation of TSH receptors by antibodies, but in rare cases can alternate between hyper- and hypothyroidism. In this case report, we describe a patient who had labile thyroid function with persistent ophthalmopathy, requiring a temporizing "block and replace" strategy for treatment.

Case Description
A 53-year-old woman with a history of GERD and fibroids presented to her primary care physician with a month-long history of hand and leg tremors, weakness, heat intolerance, palpitations and worsened anxiety. She also developed eye irritation and enlargement. Thyromegaly was noted on examination. Thyroid function tests showed that TSH was &lt;0.01 (0.45-5.33 uIU/mL) and Free T4 was 2.48 (0.61-1.12 ng/dL). TRab was 21.2 (&lt;1.75 IU/L). Thyroid ultrasound revealed heterogeneous enlargement with increased vascularity representing thyroiditis. CT orbit revealed mild bilateral ocular proptosis with normal extraocular muscle. She was diagnosed with Graves’ disease complicated by ophthalmopathy and she was started on methimazole and metoprolol. Repeat labs six weeks later improved to TSH of 0.01 and total T4 of 6.5 (4.50-11.70 ug/dL). Unfortunately, follow up labs 2 months later revealed overt hypothyroidism, with TSH of 134 with total T4 0.9. Methimazole and metoprolol were discontinued and 75mcg of levothyroxine was started. One month later, TSH was suppressed again to 0.11 and Total T4 was 17.8, so methimazole was again added with the intent of suppressing hyperthyroidism while simultaneously replacing levothyroxine to avoid hypothyroidism. Given the difficulty of maintaining a euthyroid state and ongoing symptomatic ophthalmopathy, she eventually underwent total thyroidectomy and started levothyroxine post operatively. Pathology of the thyroid gland was consistent with Graves’ disease.

Discussion
Graves’ disease is typically treated with anti-thyroid medical therapy (thioamides such as methimazole), which is titrated to a euthyroid state. In our case, the patient's thyroid function varied widely on methimazole, potentially representing variable stimulating and blocking functions of TRab. As periods of hypothyroidism can worsen ophthalmopathy, a "block and replace" treatment strategy was adopted, which involves a thioamide and levothyroxine concurrently to achieve a biochemically euthyroid state. While a Cochrane review has suggested there is no improvement in relevant outcomes using this approach, it was useful in our case as a bridge to surgical management1.

References
[1] Abraham P, Avenell A, McGeoch SC, Clark LF, Bevan JS. Antithyroid drug regimen for treating Graves’ hyperthyroidism. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD003420. DOI: 10.1002/14651858.CD003420.pub4
Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.