Discussion
DISEASE, DISEASE CHARACTERISTIC
Teduglutide is the first and only GLP-2 analogue currently available worldwide for treatment of SBS-IF [The efficacy and safety profile of teduglutide observed in Japanese patients was generally consistent across these studies as well as with the previously reported values in pivotal multinational STEPS studies [As well as differing in disease characteristics, patients in these studies were all Japanese, whereas those who participated in the STEPS international phase III studies conducted in Europe and North America were mostly Caucasian. Differences in race or ethnicities can result in variabilities in the efficacy, PK, and/or safety of some therapies; these variations can be attributed to differences in certain aspects, such as physiological and socio-cultural factors [The PK data overall were consistent with expected values for teduglutide [Generally, anti-drug antibodies can reduce the efficacy of drugs as well as cause AEs in patients, resulting in such treatments not being a viable option for patients [Limitations associated with these current studies include the small population size and the homogeneity of the population disease etiology, which are a result of the rarity of the condition of focus. The studies lacked a comparator arm, so the possibility cannot be ruled out that reductions in PS might be affected partially by spontaneous intestinal adaptation. However, a period of PS stabilization was required before enrollment, and patients in our studies had been diagnosed with SBS-IF for many years (over 5 years on average) prior to enrollment, well past the expected period of spontaneous adaptation after intestinal resection [