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Douglas L Seidner, Ken Fujioka, Joseph I Boullata, Kishore Iyer, Hak-Myung Lee, Thomas R Ziegler
Vanderbilt University Medical Center, Nashville, TN, USA.
Scripps Clinic, La Jolla, CA, USA.
Nutr Clin Pract. 2018 Aug;33(4):520-527. doi: 10.1002/ncp.10092. Epub 2018 May 15.
Patients with intestinal failure associated with short bowel syndrome (SBS-IF) require parenteral support (PS) to maintain fluid balance or nutrition. Teduglutide (TED) reduced PS requirements in patients with SBS-IF in the randomized, placebo (PBO)-controlled STEPS study (NCT00798967) and its 2-year, open-label extension, STEPS-2 (NCT00930644).
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day). Baseline was the start of TED treatment, in either STEPS or STEPS-2. At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months.
Fourteen patients enrolled (TED-TED, n = 5; NT/PBO-TED, n = 9) and 13 completed STEPS-3. At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively. Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively. Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS-2 maintained enteral autonomy throughout STEPS-3. All patients reported ≥1 treatment-emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related. No patient had a treatment-related treatment-emergent serious AE.
Long-term TED treatment yielded a safety profile consistent with previous studies, sustained efficacy, and a further decline in PS requirements.
患有短肠综合征相关肠衰竭（SBS-IF）的患者需要肠外支持（PS）以维持液体平衡或营养。特度鲁肽（TED）在随机、安慰剂（PBO）对照 STEPS 研究（NCT00798967）及其 2 年开放标签扩展 STEPS-2 研究（NCT00930644）中降低了 SBS-IF 患者的 PS 需求。
在完成 STEPS-2 的 SBS-IF 患者中进行了为期 1 年的开放标签扩展研究 STEPS-3（NCT01560403），进一步监测 TED（0.05mg/kg/天）的安全性和疗效。基线是开始 TED 治疗的时间，无论是在 STEPS 还是 STEPS-2 中。在 STEPS-3 结束时，同时在 STEPS 和 STEPS-2 中接受 TED 治疗的患者（TED-TED）接受 TED 治疗的时间≤42 个月，仅在 STEPS-2 中接受 TED 治疗的患者（无 TED 治疗[NT]/PBO-TED）接受 TED 治疗的时间≤36 个月。
共纳入 14 例患者（TED-TED，n=5；NT/PBO-TED，n=9），其中 13 例完成了 STEPS-3。在最后一次给药访视时，与基线相比，TED-TED 和 NT/PBO-TED 患者的 PS 分别降低了 9.8（14.4[50%]）和 3.9（2.8[48%]）L/周。与基线相比，TED-TED 和 NT/PBO-TED 患者的 PS 输注分别减少了 3.0（4.6）和 2.1（2.2）天/周。2 例患者实现了 PS 独立；在 STEPS-2 中实现独立的另外 2 例患者在 STEPS-3 期间维持了肠内自主。所有患者均报告了≥1 例治疗后出现的不良事件（TEAE）；3 例患者报告了与治疗相关的 TEAEs。无患者发生与治疗相关的治疗后出现严重不良事件。
长期 TED 治疗具有与先前研究一致的安全性、持续疗效和 PS 需求的进一步下降。
