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Rationale and Perspectives
The aim of this study was to examine the safety and efficacy of two new novel oral immunotherapy agents, cyclophosphamide and tacrolimus, in patients with advanced chronic active ulcerative colitis (CACUC). The primary outcome was an improvement in CD4+ T-cell count from baseline tamsulosin hydrochloride 0.4 mg capsule to week 4. Secondary outcome measures included clinical and microbiologic biomarker changes, quality of life score, as well clinical adverse events.
The study was designed to examine efficacy and safety. Patients with CACUC who received tacrolimus or cyclophosphamide (10 mg/day) for 7 days, along with rifaximin 250 mg/day, in combination with oral corticosteroids, were assigned to receive either tacrolimus-cyclophosphamide (10 mg twice weekly for 7 days, followed by 5 mg twice weekly) or placebo at week 4. Both drugs were discontinued after week 8.
Safety was assessed by adverse event surveillance and laboratory tests, including measurement of cytokine levels and the chemokine CXCL8, which was previously shown to be linked improvement in disease activity [16]. The clinical Atorvastatin 80 mg cena adverse events reported to the safety monitoring committee were proportion that was moderate (≥5/12) or severe. The primary end point was change from baseline to week 4 in the CD4+ T-cell count.
Samples of rectal microbiota were collected at baseline and week 4. The microbiome of fecal microbiota from patients with CACUC was examined using 16S rRNA gene sequencing and metagenomic analysis.
Results
The study population included 23 patients with active CACUC (mean age, 59 years, range 45–70 years) who were treated with cyclophosphamide and tacrolimus for an average of 5.9 ± 4.8 years (range = 2–8 years). Patients received either 20 mg/day, 50 or the combination of 40 mg/day, 60 and 70 mg/day for weeks 1–6 followed by 10 mg/day, 30 and 50 mg/day thereafter. Five patients were lost to follow-up during weeks 7–12, 1 patient was withdrawn due to a patient-related adverse event, and 1 patient was withdrawn from the study due to failure adhere the treatment regimen. All patients were receiving corticosteroids.
At week 4, the mean CD4+ T-cell count increased by 16.0 ± 9.3 cells/µl (mean STD) compared with baseline (18.6 ± 9.0 cells/µl) (P< 0.001). The number of CD4+ T-cells that had a positive response to cyclophosphamide at week 4 decreased from 5.9 ± 5.2 to 1.3 1.5 (P= 0.02). There were no differences between the drug groups in CD4+ T-cells that had a positive response to tacrolimus or cyclophosphamide, and the differences were not statistically significant by week 4.
Serum concentrations of cytokines associated with immune responses were assessed by ELISA. IL-6 levels were significantly increased in patients after weeks 1–4 with tacrolimus compared baseline (P = 0.03) with a maximum increase at week 4 of 7.9 ± 4.1 pg/mL (mean STD, 7.1 ± 6.2 pg/mL, P< 0.001 vs baseline). IL-2 and IL-7 levels decreased significantly between baseline and week 8 with tacrolimus (P = 0.02, 7.7±2.6 pg/mL vs baseline and 11.8 ± 6.9 pg/mL, P = 0.03, respectively). There were no statistically significant differences in IL-6 and IL-2 concentrations between the drug groups at any time point.
The patient-reported global quality of life score decreased with weeks 1–4 for all active and placebo groups (P = 0.02). The average total fatigue score over the treatment period was 3.8 ± 1.2, which is equivalent to a mean fatigue score of 3.8 ± 1.2 with placebo, 4.3 10 mg/day cyclophosphamide, and 5.0 ± 1.7 with 50 mg/day cyclophosphamide. There were no statistically significant differences between the drug groups in total fatigue score at any time point.
Quality of Life
The patient-reported global quality of life score decreased across all time points with tacrolimus compared placebo (P< 0.001). This improvement was also statistically significant (P = 0.008). There were no statistically significant differences between the drug groups in any of the patient-reported global quality life.
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