The Efficacy of Combination Therapy with Ustekinumab and Budesonide for Crohn's Disease: A Randomized Controlled Trial.

Introduction: Limited data exist on the efficacy of combination therapy with ustekinumab and budesonide in patients with Crohn's disease. Our objective was to compare the clinical outcomes of ustekinumab and budesonide combination therapy with those of ustekinumab monotherapy. Methods: In this phase 2 single-center, double-blind, randomized controlled trial, we assigned 19 patients with Crohn's disease with a Crohn's disease activity index (CDAI) equal to or greater than 220 and less than 450 in a 1:1 ratio to receive ustekinumab and budesonide or ustekinumab for 32 weeks. The primary endpoint was the clinical remission rate at 8 weeks. The secondary endpoints were the clinical remission rate at 32 weeks and mucosal healing rates at 8 and 32 weeks. Results: Of 19 patients, the mean age was 37.8 years, and 42.1% were women (CDAI ≥220 and <450). There was no difference between combination therapy and ustekinumab monotherapy in terms of clinical remission rates (50.0% vs. 30.0%, p = 0.39 at 8 weeks and 37.5% vs. 20.0%, p = 0.41) and mucosal healing rates (75.0% vs. 90.0%, p = 0.40 and 37.5% vs. 60.0%, p = 0.34 at 8 and 32 weeks, respectively). The most common adverse event was an exacerbation of Crohn's. There were no differences in safety profiles between the two groups. Conclusions: Our study showed no difference between ustekinumab monotherapy and ustekinumab and budesonide combination therapy in terms of the induction and maintenance of remission (trial registration number: jRCTs021200013).

Presence of Phlebitis in Aseptic Nasal Septal Abscess Complicated with Ulcerative Colitis; Possible Association with Granulomatosis with Polyangiitis: A Case Report.

Although nasal septal abscesses are uncommon, their cosmetic complications can be severe. Hence, prompt diagnosis and treatment are important. Here, we report a case of aseptic nasal septal abscess in a patient with proteinase 3-antineutrophil cytoplasmic antibody (PR3-ANCA)-positive ulcerative colitis (UC), in which phlebitis was observed and granulomatosis with polyangiitis (GPA) might co-exist. A 27-year-old female suffered from intermittent abdominal pain and diarrhea for several years. She visited our hospital complaining of worsening swelling and pain in the middle forehead and fever lasting 2 weeks. Physical examination and computed tomography revealed severe swelling of the nasal septum. The patient was diagnosed with nasal septal abscess, and incision drainage and biopsy from the bilateral nasal septum were performed, which showed severe ulcerative neutrophilic mucositis with phlebitis. Simultaneously, blood examination yielded slight positivity for PR3-ANCA. Colonoscopy, including biopsy, revealed severe inflammation without vasculitis nor granuloma, which led to the diagnosis with PR3-ANCA-positive UC. Phlebitis in the nasal mucosa and elevated PR3-ANCA suggested co-existing GPA; hence, she was treated with glucocorticoids and rituximab. Following treatment, the nasal septal abscess and digestive symptoms disappeared. She was discharged on day 25 without symptom recurrence or major nasal deformity. For the prevention of nasal deformity due to persistent inflammation, prompt administration of immunosuppressive therapy should be considered with adequate evaluations for systemic diseases, including UC and GPA.

Analysis of the Long-Term Prognosis in Japanese Patients with Ulcerative Colitis Treated with New Therapeutic Agents and the Correlation between Prognosis and Disease Susceptibility Loci.

BACKGROUND: New therapeutic agents, including biologics and small-molecule drugs, are widely used to treat ulcerative colitis (UC). This study evaluates long-term prognosis in Japanese patients treated with these agents and the association between prognosis and genetic susceptibility to UC. METHODS: We evaluated surgery-free rates using the Kaplan-Meier method in the total cohort and in patients treated with prednisolone and new therapeutic agents. Multivariate analysis was performed to identify clinical factors affecting surgical rates using Cox's proportional hazard model. The rate of use of new therapeutic agents was compared using the Kaplan-Meier method, and multivariate analysis was conducted to investigate the correlation between the single-nucleotide polymorphism (SNP) rs117506082 and long-term prognosis. RESULTS: Surgery-free survival decreased over time. There was no significant difference in this parameter between patients who were administered prednisolone and those who were administered new therapeutic agents. Poor response to prednisolone and treatment without topical 5-aminosalicylic acid were poor prognostic factors. Shorter time from diagnosis to initiation of treatment with new therapeutic agents was a risk factor for colectomy. The AA genotype of SNP rs117506082 was associated with a shorter time to surgery and increased use of new therapeutic agents. CONCLUSIONS: The use of new therapeutic agents might improve long-term prognosis in patients with more severe UC. Previously identified genetic risk factors were not significantly associated with a higher rate of colectomy.

Localized intestinal AL amyloidosis detected as bright green using autofluorescence endoscopy.

Amyloidosis is classifiable as systemic, with amyloid deposition in organs throughout the body, or localized, involving only one organ. Amyloidosis localized in the intestinal tract is rare. This report describes three cases of localized AL amyloidosis in the intestinal tract and presents their clinical characteristics, endoscopic findings, and prognoses. All three cases were asymptomatic, and were found accidentally during endoscopy for closer examination after a positive fecal occult blood test. Endoscopic findings included patchy redness and meandering dilated vessels of the lesion. Using autofluorescence (AFI) endoscopy, the lesion of amyloid deposition was enhanced as bright green. We used fluorescence microscopy to observe unstained specimens obtained from an amyloid deposition site with excitation light. Autofluorescence was detected with the broad excitation wavelength at amyloid deposition lesion sites of the specimen. Results revealed that AL amyloid has autofluorescence that engenders its detection by AFI endoscopy as bright green. In none of the three cases was systemic amyloidosis or organ failure observed. The long-term course of all the cases was favorable.