Teduglutide treatment can allow independence from parenteral nutrition

Reuters Health Information: Teduglutide treatment can allow independence from parenteral nutrition

Teduglutide treatment can allow independence from parenteral nutrition

Last Updated: 2016-12-22

By Will Boggs MD

NEW YORK (Reuters Health) - Many patients with intestinal failure associated with short-bowel syndrome (SBS-IF) can achieve independence from parenteral nutrition with long-term teduglutide treatment, according to a post hoc analysis of data from five clinical trials.

Teduglutide is a glucagon-like peptide-2 analog that has been shown to increase intestinal adaptation and promote intestinal absorption in patients with short-bowel syndrome.

Dr. Kishore R. Iyer from Mount Sinai Medical Center, New York, and colleagues report the clinical characteristics of 16 patients (out of a total of 134 patients) who gained oral or enteral autonomy after a median of five years of parenteral support dependence and 89 weeks of teduglutide treatment.

Most of these patients (12/16) had received at least one year of teduglutide therapy before parenteral support could be eliminated. Decreases in parenteral support occurred between one and 827 days after initiation of teduglutide.

During this time, plasma citrulline (a biomarker of intestinal mucosa mass) increased by an average 28.3%, the researchers report in the Journal of Parenteral and Enteral Nutrition, online November 23.

All patients who achieved independence from parenteral support experienced more than one treatment-emergent adverse effect, but the only treatment-emergent serious adverse effects reported in more than one patient were catheter-related infections (four cases).

Three patients developed teduglutide-specific antibodies, but no neutralizing antibodies to teduglutide were detected.

"Together, these data indicate that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term dependence on parenteral support (PS)," the researchers conclude. "Studies involving larger patient populations are required to establish factors that may predict PS independence associated with teduglutide treatment."

"Oral or enteral autonomy in patients with SBS may be conditional, particularly during periods of metabolic stress and if teduglutide treatment is discontinued," they add. "Careful monitoring and individualized patient management can allow patients to obtain optimal results."

Dr. Beth Anne Carter, medical director of the intestinal rehabilitation clinic at Texas Children's Hospital, Baylor College of Medicine in Houston, told Reuters Health by email, "I found it surprising or perhaps informative that the average time it took to achieve PS independence was >=1 year in most of the patients. This suggests that the positive intestinal effect may be 'accrued,' as the article suggests, and that prescribers will need to follow patients closely, at regular intervals, and over a period of years. The enteral autonomy, in other words, looks like it will be 'slow and steady' after initiating this medication."

"Since pediatric trials are ongoing for teduglutide, I would not yet recommend prescribing this medication to infants or children outside of the trials quite yet," said Dr. Carter, who was not involved in the study. "Look out for additional information in that patient population who may, at least theoretically, have even more innate ability for intestinal adaptation than adults."

"There is a new potential therapeutic that provides a new hope for possible better quality of life for specific adult patients who have been dependent on PS," Dr. Carter concluded. "This has been a long time coming!"

In 2012, teduglutide became the third FDA-approved drug for treating patients with SBS who need parenteral support. The others are somatropin and glutamine.

Dr. Iyer did not respond to a request for comments.

NPS Pharmaceuticals, Inc. funded the study, employed two of the authors, and had various relationships with the rest.

SOURCE: http://bit.ly/2h52RnL

J Parenter Enteral Nutr 2016.

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