BackgroundThere is paucity of head-to-head studies comparing the effectiveness of ustekinumab (UST) and adalimumab (ADA) in Crohn’s disease (CD). Here we provide a real-world comparison of these two agents.MethodsWe conducted an ambidirectional cohort study. Each patient included had moderate to severe active CD. Clinical response and remission were assessed between 4 and 16 weeks after induction.ResultsOf a total of 163 patients, 97 were induced with ADA and 66 were induced with UST. Logistic regression model analysis adjusted based on effect size showed that ADA when compared to UST induced clinical response (73.2% vs. 50% (odds ratio (OR): 2.40; 95% confidence interval (CI): 1.14 - 5.07; P = 0.02)) and remission (44.3% vs. 27.7% (OR: 2.35; 95% CI: 1.07 - 5.16; P = 0.034) in a statistically significantly higher proportion of patients. Among tumor necrosis factor (TNF)-naive patients, when comparing ADA vs. UST, ADA was superior in inducing clinical response (69/89 (77.5%) vs. 4/10 (40%) (OR: 4.26; 95% CI: 1.08 - 16.84; P = 0.04)), but not remission (41/89 (46%) vs. 3/9 (33%) (OR: 1.64; 95% CI: 0.39 - 6.97; P = 0.503)). Among TNF-experienced patients, ADA was numerically inferior in inducing clinical response (2/8 (25%) vs. 29/56 (52%) (OR: 0.38; 95% CI: 0.07 - 1.94; P = 0.24)) and remission (2/8 (25%) vs. 15/56 (27%) (OR: 1.22; 95% CI: 0.22 - 6.81; P = 0.82)), but neither of these differences were statistically significant.ConclusionsIn a real-world setting, the rate of clinical response and remission was higher among patients with CD who received ADA compared to UST. Of note, however, despite the small sample sizes of TNF-experienced patients who received ADA and TNF-naive patients who received UST, the higher effectiveness of ADA in inducing clinical response and indeed remission among patients with CD with active disease appears to primarily be driven by those who are TNF-naive. Among TNF-experienced patients, UST may be superior in inducing clinical response and equally effective in inducing clinical remission when compared to ADA. Based on this study, one may infer that among TNF-experienced patients with CD with active disease, one could consider switching to an agent such as UST instead of a second approved TNF blocker. However, larger studies comparing the two agents are required.

BackgroundVedolizumab (VDZ), an adhesion molecule inhibitor and infliximab (IFX), a tumor necrosis factor (TNF) blocker, are both approved as first-line induction agents in moderately to severely active ulcerative colitis (UC). However, there are no head-to-head studies comparing the relative effectiveness of the two agents. Here we provide a real-world comparison of these two agents.MethodsWe conducted an ambidirectional cohort study of adult UC patients seen at our tertiary inflammatory bowel disease (IBD) center from 2012 to 2017. Each patient had moderately to severely active UC via partial Mayo score and was induced with IFX or VDZ. They were followed until assessment of clinical response. Poisson regression was used to calculate clinical response rates and rate ratios.ResultsOf 59 patients who met inclusion criteria, 27 and 32 patients were induced with IFX and VDZ, respectively. Totally, 18/27 (66.7%) patients induced with IFX vs. 24/32 (78.1%) patients induced with VDZ were clinical responders. Response rates per 100 person-weeks (PW) were similar for VDZ (5.21) and IFX (5.38). The effectiveness in terms of induction of clinical response (incidence rate ratio, IRR) was not statistically significant for VDZ vs. IFX (IRR 0.97, 95% confidence interval (CI) 0.53 - 1.77). Among TNF blocker naive patients, IRR was also not statistically significant between VDZ (6.74/100 PW) and IFX (6.48/100 PW) (IRR 1.04, 95% CI 0.47 - 2.29). Among TNF blocker experienced patients, there was a higher response rate for VDZ (4.52) vs. IFX (2.29) per 100 PW, but the IRR did not reveal statistical significance (IRR 1.97, 95% CI 0.45 - 8.63) due to small sample size of TNF blocker experienced patients who received IFX. Five patients developed severe infection or adverse reaction during IFX induction requiring exclusion, whereas no VDZ patients were excluded for this reason.ConclusionsOur study revealed a higher proportion of patients who responded to VDZ vs. IFX; however when accounting for period between induction and assessment of clinical response, rates of clinical response were similar. A key difference between the two groups was the higher response rate in the VDZ group among TNF blocker experienced patients; however, a larger cohort is needed to further elaborate on this difference. VDZ held its own against IFX and this study strengthens its standing as a first-line agent among TNF blocker naive as well as TNF blocker experienced UC patients.

AIMTo study the association between vitamin D level and hospitalization rate in Crohn’s disease (CD) patients.METHODSWe designed a retrospective cohort study using adult patients (> 19 years) with CD followed for at least one year at our inflammatory bowel disease center. Vitamin D levels were divided into: low mean vitamin D level (< 30 ng/mL) vs appropriate mean vitamin D level (30-100 ng/mL). Generalized Poisson Regression Models (GPR) for Rate Data were used to estimate partially adjusted and fully adjusted incidence rate ratios (IRR) of hospitalization among CD patients. We also examined IRRs for vitamin D level as a continuous variable.RESULTSOf the 880 CD patients, 196 patients with vitamin D level during the observation period were included. Partially adjusted model demonstrated that CD patients with a low mean vitamin D level were almost twice more likely to be admitted (IRR = 1.76, 95%CI: 1.38-2.24) compared to those with an appropriate vitamin D level. The fully adjusted model confirmed this association (IRR = 1.44, 95%CI: 1.11-1.87). Partially adjusted model with vitamin D level as a continuous variable demonstrated, higher mean vitamin D level was associated with a 3% lower likelihood of admission with every unit (ng/mL) rise in mean vitamin D level (IRR = 0.97, 95%CI: 0.96-0.98). The fully adjusted model confirmed this association (IRR = 0.98, 95%CI: 0.97-0.99).CONCLUSIONNormal or adequate vitamin D stores may be protective in the clinical course of CD. However, this role needs to be further characterized and understood.

Though DAAs have eliminated many historically, long-standing medical barriers to HCV treatment, several racial, psychological and socioeconomic barriers, and disparities remain. Consequently, patients who are African American, uninsured, and actively use drugs and alcohol will suffer from increased HCV-related morbidity and mortality in the coming years if deliberate public health and clinical efforts are not made to facilitate access to DAAs.

Background and Aim Hepatitis C virus (HCV) infection is a common susceptibility factor for porphyria cutanea tarda (PCT). Experience on HCV treatment in PCT patients is limited. Recently, HCV treatment has improved with direct acting antivirals (DAA). We review our experience on HCV treatment in PCT patients with older and newer regimens. Methods HCV treatment was attempted 22 times in 13 PCT patients (five attempts in one, two in 5 and one in the other 7 patients). Results Before starting HCV treatment, PCT was in complete remission in 16, partial remission in 2, unknown status in 2, and active in 2 instances. PCT relapsed during therapy 6 times (all interferon based regimens, 2 including telaprevir), four requiring treatment interruption. Treatment was interrupted for reasons other than PCT relapse in 2 patients treated with interferon based regimens. To prevent PCT recurrence, HCQ was continued during HCV therapy 6 times (3 interferon regimens, 2 ribavirin regimens without interferon, and one DAA alone). Twelve patients achieved sustained viral response (SVR), 3 with interferon regimens and 9 with DAA. Two patients with active PCT were treated with DAA, with reduction of plasma porphyrins in one and normalization in the other at the end of HCV therapy. Conclusion HCV treatment regimens including interferon or ribavirin may precipitate PCT relapse. HCQ may be useful to prevent such relapses. In this limited experience, DAA were not associated with PCT relapse. Studies are needed to examine DAA as primary PCT treatment in HCV-infected patients.