Comparison of a second TNFi vs other biologic or targeted synthetic DMARD following an initial TNFi.

BACKGROUND: Patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis may require treatment with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Often, a tumor necrosis factor inhibitor (TNFi) is the initial b/tsDMARD. The TNFi may not be effective or may not be well tolerated, so patients will opt for a different TNFi or switch to a non-TNFi b/tsDMARD. No preference for a TNFi or non-TNFi has been established and guidelines are unclear. OBJECTIVE: To evaluate effectiveness by comparing patients using a second TNFi vs a non-TNFi after initial use of TNFi based on treatment patterns and health care utilization. METHODS: This retrospective analysis used Medicare Advantage prescription drug (MAPD) plan, Medicaid, and commercial plan claims data from Humana's Research Database (Louisville, KY). The first claim for TNFi or non-TNFi (July 1, 2016, to June 30, 2018) following earlier TNFi was the index date. Patients were required to have pre-index enrollment of 6 months and 12 months post-index along with diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, or psoriasis. During the 12-month follow-up, persistence to the index TNFi or non-TNFi was measured as continued therapy without a gap exceeding 45 days (81 days for intravenous infusions). Adherence was proportion of days covered at least 0.8. Addition of a nonbiologic DMARD or corticosteroid was also identified. Inpatient admissions and emergency department visits were observed. Inverse probability of treatment weights was used to balance cohorts. Logistic regression models were fit to TNFi vs non-TNFI on treatment and utilization measures. RESULTS: Of identified patients, 1,022 were indexed to a second TNFi and 1,024 were indexed to non-TNFi. Weighted cohorts were balanced, with mean age 56.5 vs 56.4 years, 70.5% vs 70.7% female sex, and 68.0% vs 67.9% MAPD plan. No differences were observed on persistence or adherence, with adjusted odds ratios (OR) of 1.05 (95% CI = 0.91-1.20) and 1.04 (0.91-1.20), respectively. No differences were observed for changes in therapy via switching to another TNFi/non-TNFi (OR = 0.93; 95% CI = 0.54-1.62), via nonbiologic DMARD addition (OR = 0.95; 95% CI = 0.83-1.11), or corticosteroid addition (OR = 1.09; 95% CI = 0.92-1.88). No differences were observed for hospitalization (OR = 1.16; 95% CI = 0.99-1.37) or emergency department visits (OR = 1.02; 95% CI = 0.89-1.18). CONCLUSIONS: No differences were found between a second TNFi vs a non-TNFi. As a result, choice of TNFi or non-TNFi following an initial TNFi may be driven by relevant patient-specific considerations. At the population level, policies that prefer either TNFi or non-TNFi appear reasonable. DISCLOSURES: The study was funded by Humana Inc. Mr Racsa is an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc. Drs Asante and Bloomfield are employees of Humana Inc. Dr Schwab was an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc., and is now an employee of RTI Health Solutions. Dr Cornett was an employee of Humana Inc. and is now an employee of ImmunoGen Inc.

Real-world treatment, clinical outcomes and healthcare resource utilization among persons with hemophilia A by age.

Aim: Examine real-world characteristics, treatment patterns, and outcomes among treated persons with hemophilia A (PwHA) stratified by age. Patients & methods: This study utilized US claims data from 1 January 2007-31 July 2018 from the Humana Research Database. Unadjusted comparisons were conducted across PwHA (<18, 18-55, 56-89 years) enrolled in commercial or Medicare Advantage Prescription Drug plans. Results: A total of 294 PwHA were identified; 21.1% experienced ≥1 bleeding event, and 41.2 and 53.1% had evidence of arthropathy or related disorders, and pain, respectively. Along with all-cause and hemophilia-related healthcare resource utilization (HCRU), these were highest among PwHA aged 56-89 years. Conclusion: Insights into treatment, outcomes and HCRU may identify opportunities for enhanced disease management, particularly in older PwHA.

Comparison of hepatitis C virus treatment between incarcerated and community patients.

UNLABELLED: The prevalence of chronic hepatitis C virus (HCV) infection among incarcerated individuals in the United States is estimated to be between 12% and 31%. HCV treatment during incarceration is an attractive option because of improved access to health care and directly observed therapy. We compared incarcerated and nonincarcerated HCV-infected patients evaluated for treatment at a single academic center between January 1, 2002 and December 31, 2007. During this period, 521 nonincarcerated and 388 incarcerated patients were evaluated for HCV treatment. Three hundred and nineteen (61.2%) nonincarcerated patients and 234 (60.3%) incarcerated patients underwent treatment with pegylated interferon and ribavirin. Incarcerated patients were more likely to be male, African-American race, and have a history of alcohol or intravenous drug use. Treated incarcerated patients were less likely to have genotype 1 virus and were less likely to have undergone previous treatment. There was a similar prevalence of coinfection with human immunodeficiency virus (HIV) in both groups. A sustained viral response (SVR) was achieved in 97 (42.9%) incarcerated patients, compared to 115 (38.0%) nonincarcerated patients (P = 0.304). Both groups had a similar proportion of patients that completed a full treatment course. Stepwise logistic regression was conducted, and the final model included full treatment course, non-genotype 1 virus, younger age at treatment start, and negative HIV status. Incarceration status was not a significant predictor when added to this model (P = 0.075). CONCLUSION: In a cohort of HCV-infected patients managed in an academic medical center ambulatory clinic, incarcerated patients were as likely to be treated for HCV and as likely to achieve an SVR as nonincarcerated patients.

Metastatic Kaposi's Sarcoma with Perirectal Involvement Diagnosed with Endoscopic Ultrasound-Guided EchoBrush Cytology Sampling.

AIDS-related Kaposi's sarcoma (KS) is a low-grade vascular tumor that occurs in association with human herpesvirus 8 infection. Here we report the case of a 21-year-old male with recently diagnosed cutaneous KS who presented with rectal bleeding and anal pruritus. Initial endoscopic evaluation was nondiagnostic. CT imaging showed diffuse lymphadenopathy including perirectal involvement which was suspicious for metastatic KS. Echoendoscopy with needle biopsies and EchoBrush sampling of the lymph nodes revealed spindle cells confirming metastatic KS. Treatment was initiated with liposomal doxorubicin resulting in rapid improvement of the skin lesions. After treatment completion, repeat CT imaging showed improved lymphadenopathy. No further rectal bleeding or perianal pruritus was reported. Although the EchoBrush has previously been used to aid in the diagnosis of pancreatic lesions, this report describes a novel use of EchoBrush to diagnose KS from perirectal lymph nodes.

The causes and outcome of acute pancreatitis associated with serum lipase >10,000 u/l.

OBJECTIVES: Our objective was to investigate the use of serum lipase levels >10,000 U/L as a tool for predicting the etiology of acute pancreatitis (AP) and to further address the relationship between lipase elevation and disease severity. METHODS: We compared patients with AP and serum lipase >10,000 U/L (HL) with patients with AP and lower serum lipase levels (855-10,000 U/L). The etiology and severity of AP were recorded. Differences between groups were calculated. RESULTS: Of the 114 patients in the HL group, the common etiologies of AP were biliary (68%), iatrogenic trauma (14%), and idiopathic (10%). Only one patient had alcoholic AP. Conversely, the common etiologies of AP in the 146-patient comparison group (lipase 855-10,000 U/L) were broader: biliary (34%), idiopathic (23%), alcohol (14%), and iatrogenic trauma (10%). Biliary AP was twice as common in the HL group (P < 0.0001) whereas alcoholic AP was significantly less common (P < 0.0001). The positive predictive value (PPV) for biliary AP of lipase >10,000 U/L was 80% whereas the negative predictive (NPV) for alcoholic AP was 99%. No difference between groups was observed in the severity markers including ICU admission, length of hospital stay, complications, or mortality. CONCLUSIONS: In AP a serum lipase of >10,000 U/L at presentation is a useful marker and portends a biliary etiology while virtually excluding alcoholic AP. Therefore, if ultrasonography is negative for stones in this population, these data suggest workup with MRCP or EUS is warranted to evaluate for microlithiasis or sludge given the high likelihood of occult stone disease in these individuals.

Screening colonoscopy and detection of neoplasia in asymptomatic, average-risk, solid organ transplant recipients: case-control study.

The aim of this study was to evaluate the detection of colonic neoplasia in an average-risk population of SOT recipients. Studies regarding colonic neoplasia in solid organ transplantation (SOT) recipients have demonstrated mixed results due to the inclusion of above average-risk patients. We performed a case-control study of 102 average-risk SOT recipients who underwent screening colonoscopy, compared with an average-risk, age and sex-matched control group (n=287). Cancer rates were compared with an age-matched cohort from the National Cancer Institute's Survival, Epidemiology, and End Results (SEER) database. There was no difference in number of patients with adenomas (P=1.00). There was no difference in polyps per patient (P=0.31). Although the number of advanced lesions (excluding adenocarcinoma) between groups did not differ (P=0.25), there were two adenocarcinomas identified in the SOT group and none in the control group (P=0.068). Detection of colorectal cancer was an unexpected finding in the SOT cohort and was more likely when compared to age-matched cancer incidence generated by the SEER database. These results suggest no increased adenoma detection in SOT recipients, but with more cases of colorectal cancer than anticipated. Given previous, larger, transplant database studies demonstrating increased colorectal cancer rates, more frequent screening may be justified.

Utility of colonoscopy in the evaluation of diarrhea in solid organ transplant recipients.

BACKGROUND: Diarrhea is common in solid organ transplant recipients. Colonoscopy with random biopsies is performed frequently in the diagnostic evaluation of the posttransplant population with diarrhea. The purpose of this study was to determine the sensitivity of colonoscopy with random biopsy in determining a specific diagnosis and changing management in solid organ transplant recipients with diarrhea. METHODS: From October 1996 to June 2008, 88 patients were identified who had undergone solid organ transplantation and subsequently underwent colonoscopy for an indication of "diarrhea." These patient's electronic medical records were reviewed to determine patient demographics, laboratory results, findings on colonoscopy and histopathology, and any subsequent diagnoses made and management changes in relation to the diarrhea. RESULTS: Eighty-eight patients (mean age 54 years, 65% male) underwent colonoscopy a mean of 69 months after transplantation. Abnormal colonoscopic findings were seen in 16 (18.2%) patients. Histopathology was abnormal in 17/80 (21.3%). However, only eight (9.1%) had findings on colonoscopy or pathologic condition that led to specific diagnosis being made. In addition, only nine (10.2%) patients had a change in medical management as a direct result of colonoscopy with biopsy. CONCLUSION: Although colonoscopic or histopathologic abnormalities are common in the solid organ transplant recipient with diarrhea, the findings rarely lead to a specific diagnosis or management change. Colonoscopy with biopsy should be performed only after noninvasive testing for infectious diarrhea and a thorough review and adjustment of medications. In many patients, a trial of antidiarrheal medication is warranted before colonoscopy.

Findings on optical colonoscopy after positive CT colonography exam.

BACKGROUND & AIMS: The aim of this study is to evaluate the findings on optical colonoscopy (OC) after a positive CT colonography (CTC) exam and characterize the type of polyps seen on OC but not reported by CTC. METHODS: Over an 18-month period a total of 159 asymptomatic adults had polyps seen on computed tomography colonography examination and subsequently underwent planned therapeutic optical colonoscopy. The colonoscopists were aware of the findings on CT colonography prior to further evaluation of the colon. Characteristics of polyps and adenomas seen on subsequent optical colonoscopy but not seen or reported on CT colonography were examined. RESULTS: The adenoma miss rate for CT colonography overall was 18.9% (25/132) including 6.2% (4/65) for polyps >9 mm and 18.2% (8/44) for polyps 6-9 mm. Three of the adenomas >9 mm not seen on CTC were sessile, and two were found in patients with technically difficult CT colonography studies due to poor colonic distention. No adenomas with advanced pathology <6 mm were found on optical colonoscopy but not reported on CT colonography. False-positive CTC referral where no polyp was seen on colonoscopy was 5.0%. CONCLUSIONS: CT colonography has adenoma miss rates similar to miss rates historically found with optical colonoscopy, with most missed adenomas being <10 mm and sessile in shape.