Tao Fan’s research while affiliated with Merck & Co. and other places

Background: Ulcerative colitis (UC) is a life time disease and issues with therapy may impact on patient satisfaction and treatment preferences. Aims: To assess disease and treatment perception gaps from patients' and physicians' perspectives in UC patients. Methods: Adult patients with moderate-to-severe UC (Mayo score ≥6) naïve to biologic therapy were enrolled in a European, observational, cross-sectional, retrospective study. Treatment satisfaction was assessed by the TSQM questionnaire and treatment preferences and patient's knowledge with pre-defined questions. Physicians' and patients' perceptions were compared through the level of agreement. Results: 256 patients from 11 European countries were included. 48.0% of patients were dissatisfied with their current treatment. Effectiveness, long lasting action, rapid start of action, and fewer side effects were the attributes more frequently considered important or very important by patients (96.9%, 89.1%, 83.8%, and 81.8%, respectively). 26.2% patients rated their overall disease knowledge as very knowledgeable. The agreement between patients' and physicians on disease severity was good (kappa=0.62). Conclusion: Half patients with moderate-to-severe UC managed with conventional therapy, are dissatisfied with their treatments. Effectiveness, long lasting action and rapidity of action were the most frequently rated items in treatment preferences. There are major gaps between physicians and patients when evaluating disease burden.

Background: Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL). Aim: Assess patients' perception of disease burden and unmet clinical needs in moderate/severe UC patients. Methods: Adults surgery-free conventionally treated patients with Mayo score ≥6 were enrolled in an observational, cross-sectional, retrospective study in 11 European countries. Disease control was defined as Mayo score ≤2 with no sub-score >1. No corticosteroid was used the previous two months. Unmet clinical needs were defined as: non-controlled disease, self-perception of 'moderate'/'severe' disease, and dissatisfaction with treatments. Disease burden on QoL and work productivity were assessed (EuroQol-5D-5L, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Work Productivity and Activity Impairment (WPAI) in UC questionnaire). Results: UC patients (n=253) with mean Mayo score at enrolment of 4.9, 44.3% of patients had Mayo score ≥6. Main treatment was 5-ASA (75%). Overall, 25% met the composite endpoint for unmet clinical needs. Mean (SD) questionnaire scores were: EQ-5D-5L-VAS, 71 (19.1), EQ-5D-5L utility, 0.77 (0.19), SIBDQ, 4.8 (1.3), and WPAI, 26% (32%). Conclusions: Patients with moderate/severe UC in the last 12 months treated with conventional therapies felt that their disease was not controlled and 25% reported unmet clinical needs. QoL and work productivity were seriously impaired.

The objective of this study was to evaluate long-term health-related quality of life outcomes among patients who had a colectomy within the previous 10 years. A cross-sectional survey was administered to consecutive patients ≥18 years of age with ulcerative colitis who had a colectomy within the last 10 years from centers in Canada, Australia, and the United Kingdom. Data were extracted from medical chart reviews to confirm selected self-reported patient characteristics. Of 351 survey respondents, 49 % were male and the median age was 40 years (interquartile range 30–52). Respondents were diagnosed with UC a median of 9.2 (5.7–15.1) years prior to the survey and first surgery occurred a median of 3.7 (2.1–5.8) years ago. Although most respondents (84 %) reported improved quality of life compared to the status before surgery, 81 % experienced problems in at least one of the following areas: depression, work productivity, restrictions in diet, body image, and sexual function. According to HADS scores, 30 and 17 % of survey respondents experienced anxiety and depression, respectively. Among moderate to severe UC patients pre-colectomy, 27 % of men and 28 % of women reported that their sexual life was worse now than before surgery. The mean EQ-5D utility index score overall was 0.79 (95 % confidence interval 0.77–0.81). Quality of life after colectomy for UC is generally good, but there are persistent quality of life issues that impact multiple domains, including psychological and sexual functioning. Electronic supplementary material The online version of this article (doi:10.1186/s40064-015-1350-7) contains supplementary material, which is available to authorized users.

Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are frequently treated with subcutaneous biologic therapies when disease progresses or when response to synthetic disease-modifying antirheumatic drugs (DMARDs) is inadequate. This study analyzed treatment persistence and treatment patterns for RA, AS, and PsA patients in Germany initiating subcutaneous biologic therapies with and without prior DMARDs use. A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer, Germany. Patients who were ≥18 years old; had at least one ICD-10 diagnosis code of RA, AS, or PsA during the study period; and had exposure to a subcutaneous biologic agent between January 1, 2009 and June 30, 2012 were selected. Patients were required to have continuous observation ≥12 months prior to and after index medication date. Persistence was defined as consecutive days from treatment initiation until treatment discontinuation (≥60-day lapse in medication coverage). Patients were stratified by pre-index use of DMARDs. Kaplan-Meier analysis was conducted to assess time to discontinuation, and logistic regression was conducted to identify characteristics associated with persistence. A total of 576 RA, 108 AS, and 197 PsA patients without biologic experience during the pre-index period were selected. The percentages of RA, AS, and PsA patients persistent ≥12 months were 51.9, 48.1, and 57.9 %, respectively. Median persistent time over 12 months was 365.0 days for RA (mean 245.9 days), 281.0 for AS (mean 228.5), and 365.0 for PsA (mean 264.1). In the RA cohort, a significantly higher proportion of those with pre-index DMARD use were persistent compared to those without pre-index DMARD (56.1 vs. 33.3 %, p = 0.0001). No significant differences were observed for the AS and PsA cohorts. Multivariate analyses confirmed that DMARD-experienced patients were 2.45 times more likely to be persistent with subcutaneous biologic therapy in the RA cohort. Switching between subcutaneous biologics occurred in <10 % of patients in all three cohorts. In the subpopulations with at least two prescriptions for the index subcutaneous biologic and who remained persistent on the index subcutaneous biologic, dose escalation of ≥50 % occurred in 50, 60, and 49 % in the RA, AS, and PsA cohorts, respectively. Among RA, AS, and PsA patients newly initiating subcutaneous biologic agents in Germany, persistence at 12 months is relatively low (48-58 %). For the RA cohort, patients with pre-index DMARD use are more persistent than patients without. The majority of patients do not switch between subcutaneous biologics. A notable proportion of patients who remained persistent on their index subcutaneous biologic had a dose escalation. There are opportunities to improve outcomes of patient with rheumatoid disease through improved medication persistence.

Tao Fan,1 Heather Bennett,2 Nancy E Smith,3 Mihaela Marin,2 Shuvayu Sankar Sen1 1Global Health Outcomes, Merck & Co, Inc., Whitehouse Station, NJ, USA; 2Market Access, Reimbursement and Pricing, OptumInsight, Burlington, Ontario, Canada; 3Access, Innovations and Operations, Merck & Co, Inc., Whitehouse Station, NJ, USA Objectives: As no direct comparisons have been made between infliximab and ustekinumab, the present study's aim was to estimate these drugs' relative efficacy in the treatment of moderate-to-severe psoriasis.Methods: Eleven randomized controlled trials of infliximab 5 mg/kg and ustekinumab 45 mg or 90 mg, reporting Psoriasis Area and Severity Index (PASI) 75 and PASI 90 end points, were identified from a systematic literature review. Of these, five were excluded because they had inappropriate intervention (n = 1), inappropriate patient population (n = 3), or a small sample size (n = 1). Ultimately, six studies were included in the networks. Log odds ratio (OR) of achieving PASI 75 or PASI 90 was used as the treatment effect in fixed- and random-effects mixed treatment comparison meta-analysis.Results: Based on the results of the random-effects model, when compared to infliximab 5 mg/kg, the OR of ustekinumab 90 mg and ustekinumab 45 mg achieving a PASI 75 following 12 weeks of treatment was 0.57 CrI (0.19, 1.29) and 0.44 (0.15, 0.99), respectively. Similarly, the odds of achieving PASI 90 was 0.77 (0.09, 2.70) for ustekinumab 90 mg and 0.63 (0.07, 2.20) for ustekinumab 45 mg. Infliximab 5 mg/kg had the highest probability of being the most effective of all treatments considered, in attaining a PASI 75 (92%) and PASI 90 response (76%). Ustekinumab 90 mg had the highest probability of being ranked second in attaining a PASI 75 (84%) and PASI 90 response (62%). Results from the random- and fixed-effects models were consistent.Conclusion: A greater proportion of patients with plaque psoriasis are expected to achieve a PASI 75 or PASI 90 response when treated with infliximab 5 mg/kg than with ustekinumab 90 mg or 45 mg.Keywords: TNF inhibitor, Interleukin 12/23 inhibitor, biologic therapy, comparative effectiveness, randomized clinical trial, PASI score

The burden of ulcerative colitis (UC) in relation to disease severity is not well documented. This study quantitatively evaluated the relationship between disease activity and quality of life (QoL), as well as health care utilization, cost, and work-related impairment associated with UC in an Australian population. A cross-sectional, noninterventional, observational study was performed in patients with a wide range of disease severity recruited during routine specialist consultations. Evaluations included the Assessment of Quality of Life-8-dimension (AQoL-8D), EuroQol 5-dimension, 5-level (EQ-5D-5L), the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ), and the Work Productivity and Activity Impairment (WPAI) instrument. The 3-item Partial Mayo Score was used to assess disease severity. Health care resource utilization was assessed by chart review and patient questionnaires. In 175 patients, mean (SD) AQoL-8D and EQ-5D-5L scores were greater for patients in remission (0.80 [0.19] and 0.81 [0.18], respectively) than for patients with active disease (0.70 [0.20] and 0.72 [0.19], respectively, both Ps<0.001). IBDQ correlated with both AQoL-8D (r=0.73; P<0.0001) and EQ-5D-5L (0.69; P<0.0001). Mean 3-month UC-related health care cost per patient was AUD $2914 (SD=$3447 [mean for patients in remission=$1970; mild disease=$3736; moderate/severe disease=$4162]). Patients in remission had the least work and activity impairment. More severe UC disease was associated with poorer QoL. Substantial health care utilization, costs, and work productivity impairments were found in this sample of patients with UC. Moreover, greater disease activity was associated with greater health care costs and impairment in work productivity and daily activities.

Background Ulcerative colitis is a lifelong, chronic, relapsing-remitting disease. Objective To assess the relationship between ulcerative colitis disease status and patient quality of life, and to determine the impact of ulcerative colitis on healthcare costs and work productivity, in the UK. Methods Clinicians assessed 173 adult patients’ current disease status at a single study visit using the partial Mayo (pMayo) instrument. Patients completed the Euro Quality of Life 5-dimension, 5-level (EQ-5D-5L) questionnaire, the Work Productivity and Activity Impairment (WPAI) questionnaire. Healthcare resource use was determined from questionnaires and from patients’ medical charts. Results Patients in remission had a significantly higher EQ-5D-5L scores (mean (SD) 0.86 (0.15)) than patients with active disease (0.71 (0.20); p<0.001). Patients with mild disease had significantly higher mean (SD) EQ-5D-5L scores than patients with moderate/severe disease: 0.77 (0.11) and 0.66 (0.24), respectively (p<0.001). The mean percent productivity impairment was greater for patients with active disease than for patients in remission on all items of the WPAI questionnaire: 24.6% vs 1.8% for work time missed, 34.1% vs 12.9% for impairment while working, 40.8% vs 14.4% for overall work impairment and 42.7% vs 13.0% for activity impairment (p<0.001 for all comparisons). The mean (SD) total cost of healthcare for ulcerative colitis in the prior 3 months was £1211 (1588). Conclusions When compared with patients in remission, patients with active ulcerative colitis have significantly worse quality of life and significantly more work impairment. The healthcare costs of ulcerative colitis are considerable.

Background Biologic therapies represent a significant advance in the treatment of psoriasis. However, no studies have examined the patient characteristics predictive of biologic treatment of psoriasis. The purpose of this study was to ascertain the frequency and predictors of treatment of psoriasis with biologics in three European countries, ie, France, Spain, and the UK. Methods This was a cross-sectional analysis of physician-recorded demographic and clinical data on patients receiving either conventional or biologic treatments for psoriasis. Data were drawn from the Adelphi 2007 Psoriasis Disease Specific Program (DSP®), a multinational, real-world survey of patients with psoriasis consulting practicing dermatologists. The numbers of patients treated with biologic and nonbiologic agents were recorded. Data were subjected to bivariate analysis according to treatment regimen (biologic versus nonbiologic). Predictors of treatment with biologics were identified by logistic regression analysis. Results A total of 2,509 psoriasis patients were included in this study (1,374 from France, 561 from Spain, and 574 from the UK). Biologic use was most prevalent in Spain (19.4% of patients), followed by the UK (9.1%), and France (8.4%). In the logistic regression analysis, psoriatic arthritis was a statistically significant predictor of increased biologic use in France (odds ratio [OR] 5.38, 95% confidence interval [CI] 3.32–8.77), Spain (OR 2.71, 95% CI 1.16–6.33), and the UK (OR 8.70, 95% CI 3.65–20.83). Physician-assessed moderate-to-severe disease was also a statistically significant predictor of increased biologic use in France (OR 5.08, 95% CI 2.01–12.82), Spain (OR 11.11, 95% CI 4.33–28.57), and the UK (OR 8.55, 95% CI 1.11–66.67). Conclusion In this study, an average of about one tenth of psoriasis patients enrolled in Spain, France, and the UK were treated with biologics in 2007. Physician-assessed moderate-to-severe disease and presence of psoriatic arthritis were significantly associated with biologic use in all three countries.

Background Ulcerative colitis is a lifelong, chronic, relapsing-remitting disease. Objective To assess the relationship between ulcerative colitis disease status and patient quality of life, and to determine the impact of ulcerative colitis on healthcare costs and work productivity, in the UK. Methods Clinicians assessed 173 adult patients' current disease status at a single study visit using the partial Mayo (pMayo) instrument. Patients completed the Euro Quality of Life 5-dimension, 5-level (EQ-5D-5L) questionnaire, the Work Productivity and Activity Impairment (WPAI) questionnaire. Healthcare resource use was determined from questionnaires and from patients' medical charts. Results Patients in remission had a significantly higher EQ-5D-5L scores (mean (SD) 0.86 (0.15)) than patients with active disease (0.71 (0.20); p<0.001). Patients with mild disease had significantly higher mean (SD) EQ-5D-5L scores than patients with moderate/severe disease: 0.77 (0.11) and 0.66 (0.24), respectively (p<0.001). The mean percent productivity impairment was greater for patients with active disease than for patients in remission on all items of the WPAI questionnaire: 24.6% vs 1.8% for work time missed, 34.1% vs 12.9% for impairment while working, 40.8% vs 14.4% for overall work impairment and 42.7% vs 13.0% for activity impairment (p<0.001 for all comparisons). The mean (SD) total cost of healthcare for ulcerative colitis in the prior 3 months was £1211 (1588). Conclusions When compared with patients in remission, patients with active ulcerative colitis have significantly worse quality of life and significantly more work impairment. The healthcare costs of ulcerative colitis are considerable.