Real-World Effectiveness of Ustekinumab in Ulcerative Colitis in a United States Multicenter Cohort Consortium.

BACKGROUND: Pivotal trials have shown that ustekinumab is effective in ulcerative colitis (UC). However, the population included in these trials do not represent the cohort of patients treated in the real world. In this study, we aimed to describe the effectiveness and safety of ustekinumab in a clinical cohort of patients with UC. METHODS: We performed a multicenter retrospective cohort study and included patients with active UC starting ustekinumab. Variables collected included demographics, clinical data, and disease activity (measured using partial Mayo score [PMS] and endoscopic Mayo score) at follow-up. The primary outcomes were cumulative rates of steroid-free clinical and biochemical remission (SFCBR), defined as a PMS <2 while off steroids and a normal C-reactive protein and/or fecal calprotectin. RESULTS: A total of 245 patients met inclusion criteria. The median time of follow-up was 33 (interquartile range, 17-53) weeks, and 214 (87.3%) had previous exposure to a biologic and/or tofacitinib. Rates of SFCBR, clinical remission, and endoscopic remission at 6 and 12 months were 12.0% (n = 16 of 139), 29.0% (n = 71 of 175), and 18.0% (n = 7 of 39), and 23.8% (n = 15 of 63), 54.3% (n = 57 of 105), and 31.0% (n = 9 of 29), respectively. Non-Hispanic White race, higher baseline PMS, and the use of concomitant corticosteroids were independently associated with failure to achieve SFCBR. Of the 73 that were dose escalated, 28.4% did not respond, 49.3% experienced a benefit, and 21.6% achieved remission. CONCLUSIONS: In a population enriched with refractory UC, ustekinumab was well tolerated and induced remission in a significant number of patients. Larger studies with a longer follow-up are warranted.

Ustekinumab was shown to be efficacious and safe in a population of patients with refractory ulcerative colitis. Those patients with exposure to multiple drug classes and higher disease burden at baseline are less likely to respond.

Effectiveness of Upadacitinib for Patients With Acute Severe Ulcerative Colitis: A Multicenter Experience.

INTRODUCTION: A significant proportion of patients with acute severe ulcerative colitis (ASUC) require colectomy. METHODS: Patients with ASUC treated with upadacitinib and intravenous corticosteroids at 5 hospitals are presented. The primary outcome was 90-day colectomy rate. Secondary outcomes included frequency of steroid-free clinical remission, adverse events, and all-cause readmissions. RESULTS: Of the 25 patients with ASUC treated with upadacitinib, 6 (24%) patients underwent colectomy, 15 (83%) of the 18 patients with available data and who did not undergo colectomy experienced steroid-free clinical remission (1 patient did not have complete data), 1 (4%) patient experienced a venous thromboembolic event, while 5 (20%) patients were readmitted. DISCUSSION: Upadacitinib along with intravenous corticosteroids may be an effective treatment for ASUC.

Continuing Medical Education Questions: May 2022.

Article Title: Irritable bowel syndrome and long-term risk of cancer: a prospective cohort study among 0.5 million adults in UK Biobank.

Tobacco Use is a Modifiable Risk Factor for Post-Transplant Biliary Complications.

PURPOSE: Biliary complications following liver transplantation are a significant source of morbidity, potentially leading to graft failure necessitating retransplantation. We sought to evaluate smoking as an independent risk factor for post-transplant biliary complications. METHODS: The clinical course of all adult primary deceased donor liver transplants at our center from 1992 to 2012 was reviewed. Eligible patients were assigned to cohorts based on their lifetime tobacco exposure: never smokers indicating 0 pack-year exposure and all others were ever smokers. Biliary complications were defined as strictures, leaks, or bilomas requiring intervention. Complication rates were analyzed using univariate regression models correlated with donor and recipient characteristics. Associations found during univariate analysis were included in the final multivariate Cox model. RESULTS: Eight hundred sixty-five subjects were followed for a median of 65 months; 482 (55.7%) of patients had a positive smoking history at the time of transplant. In univariate analysis, positive tobacco smoking history (HR = 1.36; p = 0.037) and increased time from quit date to transplantation (HR = 0.998; p = 0.011) were positive and negative predictors of biliary complication, respectively. Lifetime tobacco exposure remained a significant predictor of biliary complication on multivariate analysis (HR = 1.408; p = 0.023). CONCLUSIONS: Smoking status is an independent predictor of post-transplant biliary complications, and the data presented reinforces the importance of early smoking cessation in the pre-transplantation period.

Toric Implantable Collamer Lens for moderate to high myopic astigmatism.

PURPOSE: To assess the efficacy of the Toric Implantable Collamer Lens (ICL) to treat moderate to high myopic astigmatism. DESIGN: Prospective nonrandomized clinical trial. PARTICIPANTS: Two hundred ten eyes of 124 patients with between 2.38 and 19.5 diopters (D) of myopia (spherical equivalent [SE]) and 1 to 4 D of astigmatism participating in the United States Food and Drug Administration clinical trial of the Toric ICL. INTERVENTION: Implantation of the Toric ICL. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, and postoperative complications. RESULTS: At 12 months postoperatively, the proportion of eyes with 20/20 or better UCVA (83.1%) was identical to the proportion of eyes with preoperative 20/20 or better BSCVA (83.1%); 76.5% had postoperative UCVA better than or equal to preoperative BSCVA. The mean manifest refractive cylinder dropped from 1.93 D (+/-0.84) at baseline to 0.51 D (+/-0.48) postoperatively, a 73.6% decrease in astigmatism. Although only 21.0% of eyes had 1-D refractive cylinder preoperatively (none less), 91.4% of cases had < or =1 D of cylinder postoperatively. Furthermore, 65.6% had < or =0.5 D and 40.9% had < or =0.25 D of refractive cylinder postoperatively. Mean manifest refraction SE (MRSE) improved from -9.36 D (+/-2.66) preoperatively to 0.05 D (+/-0.46) postoperatively. A total of 76.9% of eyes were predicted accurately to within +/-0.5 D, 97.3% to within +/-1.0 D, and 100% to within +/-2.0 D of predicted MRSE. Postoperatively, 37.6% of eyes had a BSCVA of 20/12.5 or better, compared with a preoperative level of 4.8%. Furthermore, BSCVA of 20/20 or better occurred in 96.8% postoperatively, compared with 83.1% preoperatively. Mean improvement in BSCVA was 0.88 lines; there were 3 cases (1.6%) that lost > or =2 lines of BSCVA after 12 months postoperatively, whereas 18.9% of cases improved by > or =2 lines. A total of 76.4% of cases gained > or =1 lines of BSCVA, whereas only 7.5% of cases lost the equivalent amount. Three ICL removals were performed without significant loss of BSCVA, and 1 clinically significant lens opacity was observed. CONCLUSION: The results support the efficacy and predictability of Toric ICL implantation to treat moderate to high myopic astigmatism. Important safety concerns were not identified.

Posterior chamber phakic intraocular lens for moderate myopia and hyperopia.

BACKGROUND: As part of the United States Food and Drug Administration Phase III clinical trial, patients were implanted with the STAAR posterior chamber phakic intraocular contact lens (ICL). The trial is designed to test the safety and efficacy of this new lens for the treatment of moderate-to-high myopia and hyperopia. METHODS: Data were collected from 20 hyperopes--mean preoperative spherical equivalent, +5.55 D, and 65 myopes-mean preoperative spherical equivalent, -8.42 D, who were implanted with ICLs in our clinic, from November 1998 to March 2000. RESULTS: Postoperatively, 40% of the hyperopic eyes were 20/20 or better without correction and 80% of the eyes 20/40 or better without correction, with a mean spherical equivalent of +0.06 D. One hyperopic lens was explanted and no adverse events were reported. Postoperatively, 52.31% of the myopic eyes were 20/20 or better without correction and 92.3% of the eyes were 20/40 or better without correction, with a mean spherical equivalent of -0.31 D. No lenses were explanted and one was treated for angle closure. CONCLUSIONS: The STAAR Collamer ICL is a reasonably safe and effective procedure for the treatment of moderate-to-high refractive errors.