BACKGROUND/AIMS: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population. METHODS: Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study. RESULTS: Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. CONCLUSIONS: Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).
Asian Continental Ancestry Group* ; Crohn Disease* ; Humans ; Japan ; Tumor Necrosis Factor-alpha ; Ustekinumab*

Rectal tenesmus is a very uncomfortable symptom. Though antiarrhythmic drugs and nerve blocks have been proposed as a treatment for rectal tenesmus, none is well-established. We report a 68-year-old female who undertook surgery for uterine cervical cancer and underwent chemotherapy. She got a bilateral nephrostomy and bowel obstruction during the chemotherapy because of recurrence. She decided to stop chemotherapy and to receive palliative care. She had a symptom of rectal tenesmus, which was refractory to medications. The clinical sign was severe and uncomfortable, making her very nervous. We planned to treat the rectal tenesmus with a nerve block. A ganglion impar block was insufficient to remove the symptom, and the saddle block failed due to epidural lipomatosis. We finally succeeded in alleviating the sign with a neurolytic caudal epidural block. Relief of tenesmus made her hope to spend her final period at home. She could stay at home with her family for seven days before death without recurrence of the symptom. Though there is no report about the effectiveness of neurolytic caudal epidural block for rectal tenesmus, we consider the block appropriate for the symptom.