Use Of Teduglutide Research Articles

Teduglutida en pacientes adultos con falla intestinal crónica por síndrome de intestino corto: protocolo de manejo con base en recomendaciones de expertos

Chronic intestinal failure due to short bowel syndrome is a severe and complex disease that requires a specialized multidisciplinary treatment. Parenteral nutrition is the fundamental support in these patients; however, in the long term, complications associated with it may develop that contraindicate its continuity. In this context, an isolated or combined intestinal transplant (liver-intestine) is the last alternative to recover intestinal sufficiency. Since 2012 was introduced in the world, the use of semisynthetic GLP2 peptide, called teduglutide, changed the course and prognosis of this disease. Argentina is the Latin American country with the most experience in the use of this enterohormone, with results comparable to those of other international centers. This article summarizes the expert recommendations for the use of teduglutide in patients with chronic intestinal failure due to short bowel syndrome.

Characterization of American teduglutide consumers from 2015 to 2020: A large database study.

Teduglutide, a glucagon-like peptide-2 analog, is a novel therapy for intestinal failure that reduces need for parenteral support, especially in patients without a functional terminal ileum or colon. It can also predispose patients to accelerated progression of gastrointestinal (GI) malignancy and fluid overload. We demographically and clinically characterized American patients prescribed teduglutide. The Explorys database is an aggregate of deidentified patient data from dozens of US healthcare systems. We used SNOMED classification to identify patients prescribed teduglutide from 2015 to 2019. Through the browse cohort feature we determined the demographics, postsurgical anatomy, comorbidities, and indication for teduglutide use among these patients. Of approximately 72 million patients, 170 were prescribed teduglutide. A large majority were female (70.6%). Most common etiologies of short-bowel syndrome were intestinal obstruction (52.9%) and Crohn's disease (41.2%). Common postsurgical anatomy included total colectomy (41.2%) and ileostomy. Common incident symptoms included abdominal pain (41.2%) and nausea (23.5%). Thirty (17.6%) patients were prescribed teduglutide despite comorbid heart failure, and 5.9% despite prior GI malignancy. A total of 11.8% of patients had a history of benign GI neoplasms before starting teduglutide. A total of 5.9% of patients had posttreatment formation of colon polyps. In a large American database, the teduglutide prescription is rare. Only a minority have postsurgical anatomy associated with the most robust response to teduglutide. Serious adverse events appear rare, but a substantial number of patients are at risk for adverse effects because of the presence of comorbid heart failure or GI neoplasm.

P431 Teduglutide use and nutritional outcomes in short bowel syndrome with intestinal failure: a real-world claims database analysis

Abstract Background Teduglutide (TED) is a glucagon-like peptide 2 analogue approved for the treatment of patients with short bowel syndrome (SBS) requiring parenteral support (PS). SBS is a rare condition resulting from a reduced absorptive surface area of the small intestine, most commonly due to inflammatory bowel disease (IBD). Patients with SBS with intestinal failure (SBS-IF) remain dependent on PS to maintain adequate calorie, fluid, electrolyte and micronutrient stability. In phase 3 clinical trials, TED reduced PS requirements in patients with SBS-IF. This study aimed to assess PS use and discontinuation rates among patients with SBS on TED using real-world data. Methods This retrospective cohort study of adults with SBS-IF (≥18 years) with ≥1 TED pharmacy claim(s) used the US-based administrative healthcare claims IBM MarketScan database (2009–2019). The first TED claim was defined as the index date. Patients required ≥6 months of continuous enrolment prior to index date (baseline period) and no history of malignancy. Primary analysis was conducted during the follow-up period (index date to earliest of continuous enrolment end or 2 years post-index). A sensitivity analysis was also conducted among the cohort during the TED utilization period (index date to the earliest of continuous enrolment end or TED discontinuation). Patients required PS use during both baseline and follow-up/TED utilization periods (primary and sensitivity analyses). PS discontinuation was defined as a PS utilization gap of ≥30 days. A generalized estimating equation linear regression model evaluated if PS use (days/week) changed significantly from baseline to selected time points post-index. Results Of 110 identified patients with SBS-IF, mean age was 53.4 (SD 13.2) years and 77 (70%) were women. Included were 51 (46%) patients with Crohn’s disease and 20 (18%) with ulcerative colitis. The main comorbidities were renal disease (23%) and liver disease (15%). PS frequency was 4.6 (2.5), 3.3 (2.9), 2.9 (3.0) and 3.6 (3.0) days/week at baseline and months 6 (p<0.0001), 12 (p<0.0001), and 24 (p=0.0267), respectively. PS discontinuation increased over time to 34.4%, 46.7% and 65.2% at 3, 6, and 12 months, respectively. The sensitivity analysis demonstrated similar rates of PS use and discontinuation. Conclusion In this real-world study of adults with SBS-IF, including >50% with IBD, TED was associated with PS reductions comparable to those achieved in clinical trials and higher PS discontinuation rates even when using a conservative analysis approach. Future research will be required to determine individual predictive factors of PS discontinuation.

Candidacy of adult patients with short bowel syndrome for treatment with glucagon-like peptide-2 analogues: A systematic analysis of a single centre cohort

The glucagon-like peptide-2 (GLP-2) analogue, teduglutide, allows to reduce the intravenous supplementation (IVS) dependency of patients with short bowel syndrome and intestinal failure (SBS-IF). The rate of candidacy of SBS-IF patients for the treatment is unknown. The candidacy for teduglutide treatment of our patient cohort was investigated by a systematic analysis. The indications, contraindications, special warnings and precautions for use of teduglutide, listed in the drug monographs and in the phase-III trial protocol were adopted to categorize the patients as non-candidates (NC), potential candidates (PC) or straight candidates (SC) for the treatment. All the SBS-IF adult patients who were cured at our centre were assessed according to their clinical status on January 1st, 2020. Seventy-nine patients were evaluated: 34.2% were NC due to risk of digestive malignancy, recent history of any other cancer, or listing for intestinal transplantation; 30.4% were PC, because of other premalignant conditions, risk of intestinal obstruction, entero-cutaneous fistulas, or severe co-morbidities; 35.4% were SC. The SC group showed the lowest requirement of IVS: the lowest number of days of infusion per week (p=0.0054), the lowest amount of energy (p=0.0110) and volume (p=0.0136). This systematic analysis allowed a pragmatic categorization of the candidacy of patients with SBS-IF for GLP-2 analogue treatment. The SC group appeared to have the highest probability of a successful response to the treatment. A systematic analysis of SBS-IF patient candidate for GLP-2 analogue therapy would allow a homogeneous patient selection and facilitate the worldwide comparison of the results of clinical practice and research.

Cost-effectiveness of teduglutide in pediatric patients with short bowel syndrome: Markov modeling using traditional cost-effectiveness criteria

Teduglutide use in pediatric patients with short bowel syndrome can aid in the achievement of enteral autonomy, but with a price of >$400,000 per y. The current study evaluated the cost-effectiveness of using teduglutide in conjunction with offering intestinal transplantation in US pediatric patients with short bowel syndrome. A Markov model was used to evaluate the costs (in US dollars) and effectiveness [in quality-adjusted life years (QALYs)] of using teduglutide compared with offering intestinal transplantation. Parameters were estimated from published data where available. The primary effect modeled was the probability of weaning from parenteral nutrition while on teduglutide. Sensitivity analyses were performed on all model parameters. Compared with offering only intestinal transplantation, adding teduglutide cost ${\$}$124,353/QALY gained. Reducing the cost of the medication by 16% allowed the cost to reach the typical benchmark of ${\$}$100,000/QALY gained. Probabilistic sensitivity analysis favored transplantation without offering teduglutide in 68% of iterations at a ${\$}$100,000/QALY threshold. Never using teduglutide created an opportunity cost of over ${\$}$100,000 per patient. At its current price, teduglutide does not provide a cost-effective addition to transplantation in the treatment of pediatric short bowel syndrome. Further work should look to identify cost-reducing strategies, including alternative dosing regimens.

Experiencia con el uso de teduglutide en pacientes pediátricos con fallo intestinal en un centro de Argentina

Introduction. Teduglutide is a synthetic analogue of the glucagon-like peptide type 2, recently approved in Europe and in the United States for paediatric use, to promote intestinal adaptation in short bowel syndrome cases. The experience in children is limited. Objective. The aim of this work is to present the evolution of the first paediatric series treated with teduglutide in Argentina. Material and methods. A prospective study was realized on patient records under 18 years treated in a rehabilitation and intestine transplant unit since 2017. Of 62 children with short bowel syndrome, 5 received teduglutide 0.05 mg/kg/subcutaneous day. Diagnostics, type of anatomy and evolution of parenteral nutrition requirements were realized . Results. Etiology of short bowel syndrome: 3 congenital malformations: 2 atresias, 1 gastroschisis, two causes in older children: 1 volvulus and 1 abdominal trauma. Anatomy. Three patients type 2A, one type 2B and one type 3A, the length of the remaining intestine (mean and DS) 25.7 ± 19 cm, 1 with ileocecal valve and colon, 4 left hemicolon. The age at the beginning of parenteral nutrition was 6.2 ± 0.4 years, time on previous parenteral nutrition was 7.1 ± 4 years. The treatment time with teduglutide was 52.2 ± 39 weeks. The parenteral nutrition requirements were reduced by 56 ± 48%, in all patients, and could be suspended in 2 (at the 29th and 24th weeks of treatment). There was no deterioration of the z score of BMI/age (initial 0.16 ± 0.3 vs. 0.14 ± 1.02), nor of the height/age (-2.01 ± 1.5 vs. -1.76 ± 1.42). Conclusion. It was concluded that the use of teduglutide as a therapeutic alternative in the short bowel syndrome in paediatrics was effective and safe in this group of patients, allowing the restoration of intestinal sufficiency or reducing the requirements of parenteral nutrition.

Clinical Characteristics of Inflammatory Bowel Disease Patients Requiring Long-Term Parenteral Support in the Present Era of Highly Effective Biologic Therapy.

Despite advances in the medical management of inflammatory bowel disease (IBD), a subset of patients may require extensive surgery, leading to short-bowel syndrome/intestinal failure requiring long-term home parenteral nutrition (PN) or customized intravenous fluid (IVF) support. Our aim was to further define the characteristics of IBD patients requiring home PN/IVF. This is an observational study from a prospective IBD research registry. Patients receiving long-term home PN/IVF support during 2009-2015 were identified and compared with remaining IBD patients. Demographics, surgical history, smoking, narcotic use, IBD treatment, healthcare charges, and presence of biomarkers were reviewed. The IBD-PN group was stratified into 3 groups based on median healthcare charges. Of 2359 IBD patients, there were 25 (1%, 24 with Crohn's disease) who required home PN/IVF, and 250 randomly selected IBD patients matched for disease type formed the control population. Median duration of PN use was 27 months (interquartile range, 11-66). PN use was significantly associated with smoking, narcotic use, IBD-related operations, and lower quality-of-life scores. Among IBD-PN patients, 7 of 25 (28%, 3 after use of teduglutide) were able to successfully discontinue this modality. Median healthcare charges in the IBD-PN group were $51,456 annually. Median charges in the controls were $3427. Period prevalence mortality was 11.5% in IBD-PN and 3.8% in controls. IBD patients requiring long-term home PN/IVF support are a small minority in the present era of immunomodulator/biologic therapy. These refractory patients have a 15-fold increase in annual median healthcare charges compared with control IBD patients.

Calidad de vida de las personas adultas con nutrición parenteral ingresadas en hospitalización domiciliaria: revisión sistemática

Objetivo: Revisar la documentación científica relacionada con la calidad de vida de las personas adultas con nutrición parenteral ingresadas en hospitalización domiciliaria.Método: Revisión crítica y sistemática. Los datos se obtuvieron de la consulta a las siguientes bases de datos bibliográficas: MEDLINE (vía PubMed), Cochrane Library, Embase, Scopus y Web of Science. Los términos utilizados, como descriptores y como texto en los campos de registro del título y el resumen, fueron “Home Care Services”, “Parenteral Nutrition” y “Quality of Life”, utilizando los filtros «Humans», «Adult: 19+ years» y «Clinical Trial». Fecha de la búsqueda febrero de 2020. La calidad documental de los artículos se evaluó mediante el cuestionario CONSORT.Resultados: De las 379 referencias recuperadas, tras depurar las repeticiones y aplicar los criterios de inclusión y exclusión, se seleccionaron 7 ensayos clínicos. En 3 (43%) de los ensayos revisados se observó una mejora en relación a la calidad de vida. Las puntuaciones obtenidas mediante el cuestionario CONSORT, oscilaron entre 12,5 y 20,5 sobre una puntuación máxima de 24.Conclusiones: El incremento de la calidad de vida de los enfermos con NPD está directamente relacionado con la del estado y soporte nutricional de los mismos. Se observó una mejor calidad de vida en los pacientes con bomba portátil y en los que se administró teduglutida. El adecuado manejo del catéter y la consecuente disminución de las infecciones también contribuyó a la mejora de la calidad de vida de las personas con NPD.

Long-Term Outcomes With Teduglutide From a Single Center.

The aim of this study was to quantify the long-term clinical outcomes for individuals receiving teduglutide for short-bowel syndrome (SBS). A single-center, retrospective study was performed for individuals commencing use of teduglutide between March 2013 and May 2019. Eighteen patients were included in the final analysis, among which the median duration of teduglutide administration was 3.2 (range, 0.6-6.2) years. Twelve of 16 (75%) patients at 12 months, 10 of 13 (76.9%) at 24 months, 7 of 10 (70%) at 36 months, and 3 of 3 (100%) at 60 months had a response to teduglutide therapy, defined as a >20% reduction in parenteral support (PS) requirement. Among responders at 12, 24, and 36 months, the presence of a colon-in-continuity, an ileocecal valve, a response at 3 months, the length of small bowel, nor the baseline volume affected response to therapy (P > .05 for all comparisons). Five (28%) patients were able to achieve freedom from PS, among which all had a history of Crohn's disease with loss of the ileocecal valve and among which 3 had a colon-in-continuity. Four of the 5 patients discontinued PS by 6 months of teduglutide therapy. In a real-world experience, teduglutide therapy results in rapid and sustained reductions in PS. Larger postmarketing studies will be required to reliably predict response to treatment and the factors associated with enteral autonomy.

P108 TEDUGLUTIDE USE IN CROHN’S DISEASE: A CASE SERIES

Abstract Background Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue with trophic effects on the intestinal mucosa to increase the absorptive surface area and enhance nutrient and fluid absorption of the small bowel (SB).1 It has been shown to reduce parenteral nutrition (PN) and intravenous fluid (IVF) requirements and is an important adjunct in the medical management of short bowel syndrome (SBS).1–2 Crohn’s disease (CD) is an important etiology of SBS but use of teduglutide in this population can be challenging. Aim The aim of this case series was to describe the use of teduglutide in CD patients. Methods A retrospective case series of all CD patients with SBS who used teduglutide at the Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center. Age, duration of SBS, length of remaining SB and colonic continuity status were recorded. BMI, average daily PN kilocalories (kcal), and IVF requirements were recorded at the time of teduglutide initiation. The duration of teduglutide use was calculated. Teduglutide dose, dose adjustment history, reason for dose adjustment, and therapy complications were noted. Results 9 patients were included (5 male/4 female). Median age was 57 years (IQR 32). Median length of remaining small bowel was 60cm (IQR 27.5) and median duration of SBS was 8 years (IQR 9.83). Median BMI at teduglutide initiation was 18.66 (IQR 4.29) with a median duration of PN of 4.5 years (IQR 9.42) and median PN kcal/day of 971.43 (IQR 518). The median duration of teduglutide was 1.1 years (IQR 3.4). 4 patients (44%) had a teduglutide dose change. 2 patients had dose interval extended from daily to every other day to reduce injection burden. 1 patient developed obstructive symptoms on daily dosing, which resolved when the dose interval was extended to every other day. 1 patient had to stop therapy due to a small bowel obstruction requiring hospitalization. 8 patients (88%) were able to wean or stop PN/IVF with addition of teduglutide. 1 patient had to restart PN despite teduglutide therapy. Table 1. Discussion Teduglutide is effective in Crohn’s disease patients and facilitates weaning of PN and IVF requirements. Most patients tolerate the recommended dose with daily injections, but the dose interval can be extended to every other day to reduce obstructive symptoms or reduce the injection burden without affecting ability to wean PN/IVF. References

Cost-effectiveness of teduglutide in adult patients with short bowel syndrome: Markov modeling using traditional cost-effectiveness criteria

Adults with short bowel syndrome have a high mortality and significant morbidity due to unsuccessful attempts at rehabilitation that necessitate chronic use of parenteral nutrition (PN). Teduglutide is a novel therapy that promotes intestinal adaptation to improve rehabilitation but with a price >$400,000/y. The current study evaluated the cost-effectiveness of using teduglutide in US adult patients with short bowel syndrome. A Markov model evaluated the costs (in US dollars) and effectiveness (in quality-adjusted life years, or QALYs) of treatment compared with no teduglutide use, with a presumed starting age of 40 y. Parameters were obtained from published data or estimation. The primary effect modeled was the increased likelihood of reduced PN days per week when using teduglutide, leading to greater quality of life and lower PN costs. Sensitivity analyses were performed on all model parameters. In the base scenario, teduglutide cost $949,910/QALY gained. In 1-way sensitivity analyses, only reducing teduglutide cost decreased the cost/QALY gained to below the typical threshold of $100,000/QALY gained. Specifically, teduglutide cost would need to be reduced by >65% for it to reach the threshold value. Probabilistic sensitivity analysis favored no teduglutide use in 80% of iterations at a $100,000/QALY threshold. However, teduglutide therapy was cost-saving in 13% of model iterations. Teduglutide does not meet a traditional cost-effectiveness threshold as treatment for PN reduction in adult patients with short bowel syndrome compared with standard intestinal rehabilitation. Subpopulations that demonstrate maximum benefit could be cost-saving, and complete nonuse could lead to financial loss. Teduglutide becomes economically reasonable only if its cost is substantially reduced.

Translation of Evidence Into Practice With Teduglutide in the Management of Adults With Intestinal Failure due to Short-Bowel Syndrome: A Review of Recent Literature.

Chronic intestinal failure (CIF) due to short-bowel syndrome (SBS) is characterized by failure to achieve optimal intestinal adaptation required to maintain oral/enteral autonomy. The conventional management strategy relies heavily on home parenteral support (PS; parenteral nutrition and/or intravenous fluids). Teduglutide, an analog of the hormone glucagon-like peptide-2, facilitates intestinal adaptation, as evidenced by reductions in PS volume in patients with SBS-associated CIF. In 2016, the European Society for Clinical Nutrition and Metabolism (ESPEN) developed guidelines for the management of adult patients with CIF, consisting of a comprehensive list of recommendations. Owing to the limited number of studies at the time of the finalization of the GRADE-method review of the available literature, teduglutide received a moderate grade of evidence (GOE) as the first choice for growth-factor treatment in patients with SBS-CIF. The GOE was also low for 7 points of recommended information to be discussed with the candidate patients. This review summarizes findings from recent studies that fill some gaps identified in the 2016 ESPEN guidelines regarding the use of teduglutide in the management of SBS-CIF. Collectively, these studies provide useful information about the probability and timing of clinical response in the individual patient. Also, recent studies report longer-term safety findings with teduglutide. These results can help physicians better manage patients with SBS-CIF by aligning clinical decision making with specific disease characteristics, setting the right expectations, and encouraging treatment adherence.

P4.34: Long term use of Teduglutide (TED) for Type III Intestinal Failure (III-IF) in Adults Patients (pts). A single center experience.

P4.34: Long term use of Teduglutide (TED) for Type III Intestinal Failure (III-IF) in Adults Patients (pts). A single center experience.

Five years of experience with use of Teduglutide

Five years of experience with use of Teduglutide

Single-Center Experience with the Use of Teduglutide in Adult Patients with Short Bowel Syndrome.

Teduglutide is a glucagon-like peptide 2 (GLP-2) analog that has been approved for the treatment of adult short bowel syndrome (SBS)-associated intestinal failure (IF; SBS-IF). Teduglutide increases villus height and crypt depth in the small bowel mucosa, promoting nutrition absorption and enteral independence from parenteral nutrition (PN). We aim to report our single-center experience with teduglutide in adult patients with SBS to provide real-world context to its use. We conducted a retrospective analysis on patients managed within our tertiary-level intestinal rehabilitation program to identify patients with SBS-IF treated with teduglutide from 2009-2015. The current report includes all patients at our center who had any exposure to teduglutide, including those who received commercial drug after approval by the Food and Drug Administration (FDA) and outside the scope of clinical trials. A total of 18 patients were treated with teduglutide. Eleven patients (61%) achieved complete enteral independence from PN and/or intravenous fluids (IV) at a median time of 10months (range: 3-36 months). PN/IV volume requirement was reduced in all patients except two. Ten of the 11 patients (91%) who achieved enteral autonomy had colon. All patients off PN/IV required additional oral vitamins and electrolyte supplementations. Our preliminary experience is consistent with prior reports of successful partial or complete weaning from PN/IV with teduglutide treatment in adult patients with SBS. The presence of colon appears to be favorable in obtaining enteral independence from PN/IV, regardless of residual small bowel length. Patients on teduglutide may remain at high risk of micronutrient deficiencies.

Alveolar Rhabdomyosarcoma in a 69-Year-Old Woman Receiving Glucagon-Like Peptide-2 Therapy.

A 69-year-old woman was diagnosed with alveolar rhabdomyosarcoma (ARMS) of the nasopharynx. She has a history of catastrophic thromboembolic event in the abdomen that caused short-gut syndrome and dependence on total parenteral nutrition (TPN) twelve hours per day. She was treated for short-gut syndrome with teduglutide, a glucagon-like peptide-2 (GLP-2) analog, which led to reduction of TPN requirements. However, a few months later, she developed metastatic alveolar rhabdomyosarcoma. Though a causative relationship is unlikely between the peptide and ARMS due to the brief time course between teduglutide therapy and sarcoma diagnosis, neoplastic growth may have been accelerated by the GLP-2 analog, causing release of IGF-1. The transmembrane receptor for IGF-1 is frequently overexpressed in ARMS and is implicated in cell proliferation and metastatic behavior. This case describes a rare incidence of metastatic alveolar rhabdomyosarcoma in a sexagenarian and possibly the first case reported associated with the use of teduglutide. Teduglutide was discontinued due to a potential theoretical risk of acceleration of sarcoma growth, and the patient's rhabdomyosarcoma is in remission following sarcoma chemotherapy.

Teduglutide for the treatment of short bowel syndrome

Glucagon-like peptide 2 (GLP-2) decreases gastric and intestinal motility, reduces gastric secretions, promotes intestinal growth and improves post-resection structural and functional adaptation in short bowel syndrome (SBS). Teduglutide, an analogue of GLP-2, has a prolonged half-life and provides intestinotrophic effects with once-daily subcutaneous injection in patients with SBS. This monograph reviews the preclinical and clinical data that provide the scientific rationale for the use of teduglutide in this orphan condition. Teduglutide increases intestinal absorption and diminishes the need for parenteral support in patients with SBS. The adverse event profile is consistent with the underlying disease and the known mechanism of action of teduglutide. Following its positive regulatory review and approval by the European Medicines Agency and the U.S. Food and Drug Administration in 2012, teduglutide has moved from the research setting to clinical practice, offering a new treatment paradigm for this burdensome and potentially life-threatening condition.

Teduglutide in intestinal adaptation and repair: light at the end of the tunnel

Background: Malabsorption of nutrients, fluids and electrolytes is a key finding in patients with short bowel syndrome. If not compensated for by increased intake, it leads to diminished body stores and subclinical, and eventually clinical, deficiencies. Until recently, management options were limited to interventions aimed at provision of adequate macro- and micronutrients and fluids to prevent malnutrition, nutrient deficiencies and dehydration, treatment of associated infections and correction and prevention of acid-base disturbances. Identification of novel gut hormones, combined with the growing understanding of their pivotal role in intestinal adaptation, has provoked interest in developing more specific therapies. Aim: To provide an update on the recent advances on the use of teduglutide in patients with short bowel syndrome. Methods: A comprehensive Medline search using the terms teduglutide, ALX-0600, dipeptidyl peptidase IV (DPP-IV) and glucagon like peptide-2 (GLP-2). Results: Teduglutide (GATTEX™, ALX-0600; NPS Allelix Corp) is a synthetic DPP-IV-resistant recombinant human GLP-2 analog that differs from GLP-2 only by an N-terminus substitution of glycine for alanine in position 2 of the peptide that renders the component resistant to enzymatic degradation. Based on the results of the few Phase II studies and the preliminary results of a Phase III trial, teduglutide at doses of 0.05 or 0.10 mg/kg/day may improve many clinical, laboratory and histologic abnormalities in short bowel syndrome patients. It appears to be safe and well tolerated. Conclusion: Teduglutide is a first-in-class therapy with the potential to create a new standard of care for patients suffering from short bowel syndrome. Future studies to address the appropriate initial and maintenance dosage and optimal duration of treatment are needed.