Pulmonary exacerbations in insured patients with bronchiectasis over 2†years.

Background: Patients with bronchiectasis experience persistent symptoms and frequent pulmonary exacerbations; this study investigated the frequency of exacerbations and all-cause hospitalisation. Methods: This longitudinal, retrospective, claims database study (IBM® MarketScan®) identified patients aged ≥18 years from 1 July 2015 through 30 September 2018. Exacerbations were identified by bronchiectasis inpatient claim or a healthcare interaction, followed by antibiotic prescription within 7 days. Patients with ≥36 months of continuous health plan enrolment (12 months preceding the first bronchiectasis claim, i.e., baseline period and ≥24 months of follow-up) were included. Patients with cystic fibrosis at baseline were excluded. A multivariable logistic regression model identified baseline factors associated with having ≥2 exacerbations over the 2-year follow-up period. Results: In total, 14 798 patients with bronchiectasis were identified; 64.5% were female, 82.7% were aged ≥55 years and 42.7% had ≥2 exacerbations at baseline. Having ≥2 exacerbations after 2 years was positively associated with chronic macrolide use, long-acting ß2 agonist use, gastro-oesophageal reflux disease, heart failure and Pseudomonas aeruginosa. Frequent exacerbations (≥2) at baseline were significantly associated with greater likelihood of experiencing ≥2 exacerbations during the first and second year's follow-up (unadjusted odds ratios 3.35 (95% CI 3.1-3.6) and 2.96 (95% CI 2.8-3.2), respectively). The proportion of patients experiencing ≥1 all-cause hospitalisation cumulatively increased from 41.0% in the first year of follow-up to 51.1% over 2 years' follow-up. Conclusion: Frequent exacerbations in patients with bronchiectasis may increase the likelihood of future exacerbations over 2 years of follow-up, with increased hospitalisation rates over time.

Clinical and economic burden of intravenous paclitaxel or nab-paclitaxel for metastatic breast cancer.

BACKGROUND: Intravenous (IV) taxane therapy for metastatic breast cancer (mBC) has been associated with toxicities and demanding dosing schedules, which can limit treatment effectiveness. OBJECTIVES: To assess treatment patterns, toxicities, and costs in women with mBC initiating IV paclitaxel or IV nab-paclitaxel. METHODS: Adult women diagnosed with BC from January 1, 2014, to September 30, 2018, were identified in the MarketScan Commercial and MarketScan Medicare Supplemental databases. Women had a metastatic disease diagnosis and newly initiated treatment with IV paclitaxel/nab-paclitaxel (first administration date was considered the index date), and continuous enrollment for at least 12 months prior to and at least 3 months following the index date. Treatment discontinuation, dose reductions, toxicities, and health care utilization and costs per patient per month (PPPM) were assessed over the full follow-up and the index line of IV paclitaxel/nab-paclitaxel therapy (Index LOT). RESULTS: The sample included 8890 women aged 54.6 (±10.9) years, followed for 18.9 (±13.5) months. Most (82.0%) initiated IV paclitaxel/nab-paclitaxel monotherapy; 83.1% had early discontinuation (<18 weeks of treatment) of the Index LOT. Among the 6943 women eligible for the dose-change analysis, 42.4% evidenced an IV paclitaxel/nab-paclitaxel dose reduction ≥10% during the Index LOT. The most common toxicities during the Index LOT were gastrointestinal upset (30.5%), myelotoxicity (27.0%), infection (26.2%), general symptoms (25.9%), and chemotherapy-induced peripheral neuropathy (22.7%). Over follow-up, 39.7% of women had an inpatient admission and 43.0% had an emergency department visit. The mean of all-cause total costs was $11,991 PPPM, while BC-related total costs were $5320 PPPM. CONCLUSIONS: Many mBC patients initiating IV paclitaxel/nab-paclitaxel experienced dose reductions, toxicities, and/or early discontinuation of the Index LOT, which may limit treatment effectiveness. More tolerable treatments with reduced dosing complexity could improve mBC treatment and help contain costs.

Chemotherapy-induced peripheral neuropathy in metastatic breast cancer patients initiating intravenous paclitaxel/nab-paclitaxel.

BACKGROUND: Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes. OBJECTIVE: To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel. METHODS: Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score-matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up. RESULTS: Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC-related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01). CONCLUSIONS: CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

Meningococcal-group B (MenB) vaccine series completion and adherence to dosing schedule in the United States: A retrospective analysis by vaccine and payer type.

BACKGROUND: Two MenB vaccines with different dosing schedules are approved in the US: MenB-4C (2 doses) and MenB-FHbp (2-3 doses). Both vaccines were licensed on the basis of immunogenicity demonstrated after vaccine series completion. We evaluated vaccination completion and adherence to dosing schedules. METHODS: This retrospective analysis used data from MarketScan Commercial Claims and Encounters Database (Commercial) January 1, 2015 - February 28, 2018 and Multi-State Medicaid Database (Medicaid) January 1, 2015 - December 31, 2017 to examine vaccine series completion and adherence to dosing schedule in individuals who initiated a MenB series at ages 16-23 years. Vaccine series completion and dose schedule adherence were assessed during a 15-month follow-up period after the first dose. Completion was defined as individual receipt of the recommended number of doses, with current recommendations applied retroactively to allow individuals who initiated the MenB-FHbp series to be complete with either the 2- or the 3-dose schedule. RESULTS: The study population comprised 65,205 commercially-insured individuals (36,118 initiated MenB-4C; 29,087 initiated MenB-FHbp) and 13,535 Medicaid-covered individuals (10,153 initiated MenB-4C; 3382 initiated MenB-FHbp). In Commercial, 63% of individuals who initiated MenB-4C and 52% of individuals who initiated MenB-FHbp completed vaccination within 15 months; dosing schedule adherence was 62% for MenB-4C initiators and 18% for MenB-FHbp initiators. In Medicaid, 15-month completion rates for MenB-4C and MenB-FHbp initiators were 49% and 31%, respectively, with corresponding dosing schedule adherence of 48% and 8%. Among individuals who completed the series, median time to completion was 68 days for MenB-4C versus 258 days for MenB-FHbp in Commercial and 88 days for MenB-4C versus 309 days for MenB-FHbp in Medicaid. CONCLUSION: During the study period, MenB vaccine series completion was suboptimal. However, completion was significantly higher for MenB-4C, with notably shorter time to completion. This may reflect the flexible dosing schedule of MenB-4C.

Inflammatory Bowel Disease Provoked by Etanercept: Report of 443 Possible Cases Combined from an IBD Referral Center and the FDA.

BACKGROUND: Anti-TNF therapies have revolutionized the treatment of autoimmune inflammatory conditions. Paradoxical treatment with these agents is associated with the development of de novo autoimmune diseases. Less well recognized is the provocation of de novo IBD by these agents. Etanercept is not effective for the treatment of inflammatory bowel disease and may be more often reported with the development of Crohn's disease or ulcerative colitis. AIM: This study assessed the association of new onset IBD in patients with receiving etanercept. METHODS: The Brigham and Women's (BWH) patient database and the FDA Adverse Event Reporting System were searched for cases of IBD reported with etanercept. RESULTS: A total of 443 cases were identified: 5 pts at BWH (3 CD, 2 UC) and 438 (294 CD, 144 UC) reported to the FDA. Data which were most complete were pooled from 49 patients. NSAID use was reported in 43 % and combination with methotrexate in 29 %. Etanercept was discontinued in 34 pts and 19 required treatment with a different anti-TNF agent. Eight patients had resolution of GI symptoms on discontinuation of etanercept. Therapy was continued in three patients in response to 5-ASA therapy. CONCLUSION: Development of IBD should be suspected in patients receiving etanercept who develop GI symptoms. This phenomenon appears more commonly associated with initiation of CD. The clinical phenotype appears indistinguishable from usual patterns of IBD. Unlike other autoimmune phenomenon associated with anti-TNF therapy, IBD often does not resolve when the agent is discontinued. This tentative association requires further investigation.

Efficacy of Vedolizumab as Induction Therapy in Refractory IBD Patients: A Multicenter Cohort.

BACKGROUND: Vedolizumab (VDZ) demonstrated efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in the GEMINI trials. Our aim was to evaluate the efficacy of VDZ at week 14 in inflammatory bowel disease in a multicenter cohort of patients. METHODS: Patients at Massachusetts General Hospital and Brigham and Women's Hospital were considered for inclusion. VDZ (300 mg) was administered at weeks 0, 2, 6, and 14. Efficacy was assessed using the Harvey-Bradshaw index for CD, the simple clinical colitis activity index for UC and physician assessment, along with C-reactive protein and decrease of corticosteroid therapy. Clinical response was defined as decrease in Harvey-Bradshaw index ≥3 and simple clinical colitis activity index ≥3 and remission as Harvey-Bradshaw index ≤4, simple clinical colitis activity index ≤2 and physician assessment of response and remission. RESULTS: Our study included 172 patients (107 CD, 59 UC, 6 inflammatory bowel disease-unclassified, men 48.3%, mean age 40 years and disease duration 14 years). Fourteen patients had ostomy and 9 ileoanal pouch, and only 35.5% fulfilled eligibility for the GEMINI trials. Previous treatment failures with ≥ 2 anti-TNFs occurred in 70.9%, one-third were on an immunomodulator and 46% systemic steroids at baseline. In CD, 48.9% and 23.9% and in UC, 53.9% and 29.3% had clinical response and clinical remission at week 14, respectively. Adverse events occurred in 10.5%. CONCLUSIONS: VDZ is safe and well tolerated in refractory inflammatory bowel disease patients in a clinical practice with efficacy in UC and CD with responses similar to what was seen in clinical trials.

Risk Factors for Rehospitalization Within 90 Days in Patients with Inflammatory Bowel Disease.

BACKGROUND: Care of patients with inflammatory bowel disease (IBD) poses a significant burden to the health-care system. Repeat hospitalization in subgroups of IBD patients seems to be a large part of this issue; however, there are limited data examining the characteristics of these patients. The aim of this study was to characterize admission patterns in patients with IBD at a tertiary-care center and to identify preventable risk factors of 90-day readmission after an index IBD admission. METHODS: Retrospective analysis was performed extracting data from an electronic medical record over a 2-year period. RESULTS: Three hundred fifty-six patients were admitted at least once during the 2-year study period for an unplanned IBD-related reason. Of these, 48.9% were admitted once, 38.2% were admitted 2 to 4 times, and 12.9% were admitted 5 or more times during the study period. Patients with any admission within 90 days before index were excluded; n = 33. One hundred two patients had experienced a readmission by 90 days after index admission. Numerous demographic and medical factors were examined for association with readmission. The final Cox model included 3 variables: depression (HR = 1.99, 1.33-3.00), chronic pain (HR = 1.88, 1.14-3.10), and steroid use in the previous 6 months (HR = 1.33, 0.92-2.04). CONCLUSIONS: Our findings suggest that patients with depression and chronic pain are at greatest risk for a readmission within 90 days after an initial IBD admission. Disease activity, represented by steroid use in the previous 6 months, was not related to readmission. Addressing these problems in the outpatient setting may reduce future hospitalizations.

Factors associated with durable response to infliximab in Crohn's disease 5 years and beyond: a multicenter international cohort.

BACKGROUND: Infliximab (IFX) has been used for over a decade worldwide. Less is known about the natural history of IFX use beyond a few years and which patients are more likely to sustain benefits. METHODS: Patients with Crohn's disease (CD) exposed to IFX from Massachusetts General Hospital, Boston, Saint-Antoine Hospital, Paris, and the Swiss IBD Cohort Study were identified through retrospective and prospective data collection, complemented by chart abstraction of electronic medical records. We compared long-term users of IFX (>5 yr of treatment, long-term users of infliximab [LTUI]), with non-LTUI patients to identify prognostic factors. RESULTS: We pooled data on 1014 patients with CD from 3 different databases, of whom 250 were defined as LTUI. The comparison group comprised 290 patients with CD who discontinued IFX: 48 primary nonresponses, 95 loss of responses, and 147 adverse events. Factors associated with LTUI were colonic involvements and an earlier age at the start of IFX. The prevalence of active smokers and obese patients differed markedly, but inversely, between American and European centers but did not impact outcome. The discontinuation rate was stable around 3% to 6%, each year from years 3 to 10. CONCLUSIONS: Young age at start of IFX and colonic CD are factors associated with a beneficial long-term use of IFX. After 5 years of IFX, there is still a 3% to 5% discontinuation rate annually. Several factors associated with a good initial response such as nonsmoker and shorter disease duration at IFX initiation do not seem associated with a longer term response.

Marijuana use patterns among patients with inflammatory bowel disease.

BACKGROUND: The prevalence and perceived effectiveness of marijuana use has not been well studied in inflammatory bowel disease (IBD) despite increasing legal permission for its use in Crohn's disease. Health care providers have little guidance about the IBD symptoms that may improve with marijuana use. The aim of this study was to assess the prevalence, sociodemographic characteristics, and perceived benefits of marijuana use among patients with IBD. METHODS: Prospective cohort survey study of marijuana use patterns in patients with IBD at an academic medical center. RESULTS: A total of 292 patients completed the survey (response rate = 94%); 12.3% of patients were active marijuana users, 39.0% were past users, and 48.6% were never users. Among current and past users, 16.4% of patients used marijuana for disease symptoms, the majority of whom felt that marijuana was "very helpful" for relief of abdominal pain, nausea, and diarrhea. On multivariate analysis, age and chronic abdominal pain were associated with current marijuana use (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.89-0.97; P < 0.001 and OR, 3.5; 95% CI, 1.24-9.82; P = 0.02). Age and chronic abdominal pain were also multivariate predictors of medicinal use of marijuana (OR, 0.93; 95% CI, 0.89-0.97; P < 0.001 and OR, 4.7; 95% CI, 1.8-12.2; P = 0.001). Half of the never users expressed an interest in using marijuana for abdominal pain, were it legally available. CONCLUSIONS: A significant number of patients with IBD currently use marijuana. Most patients find it very helpful for symptom control, including patients with ulcerative colitis, who are currently excluded from medical marijuana laws. Clinical trials are needed to determine marijuana's potential as an IBD therapy and to guide prescribing decisions.