Unspecified Intestinal Malabsorption Associated with Angiotensin Receptor Blocker Therapy: Results from a Nationwide, Population-Based Study in Italy and Germany

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decisions as well as included potential pricing and access outcomes a product will achieve in the next 5 years. Respondents concluded that there are several tools and models that have been experimented, however the challenges of implementation and continuity remain. More so for bigger organisations with more than 6 products in the pre-launch and launch phase, communication models with cross functional interactive framework were desired.

DISEASE – SPECIFIC STUDIES

GASTROINTESTINAL DISORDERS – Clinical Outcomes Studies PGI1 Unspecified Intestinal Malabsorption Associated with Angiotensin Receptor Blocker Therapy: Results from a Nationwide, PopulationBased Study in Italy and Germany Ripellino C1, Cataldo N1, Scarpignato C2 1IMS Health, Milan, Italy, 2University of Parma, Parma, Italy

Objectives: To investigate the possible relation between the use of Angiotensin II Receptor Blockers (ARBs) and sprue-like enteropathy (SLE) within the Italian and German real-life context.  Methods: A retrospective cohort of newly diagnosed patients with Unspecified Intestinal Malabsorption (IM) was extracted from IMS Health Longitudinal Patient Database (IMS Health LPD) and German IMS Disease Analyzer database during the period from 1 January 2010 to 31 December 2013. Only patients with at least one prescription of a molecule belonging to ARB drug class during the six months preceding the IM diagnosis were included and they were followed-up for a 12-month period in order to assess treatment interruptions.  Results: Newly diagnosed unspecified IM patients were 128 and, among them, 33 patients (25.8%) were treated with candesartan, 30 with valsartan (23.4%), 22 with olmesartan (17.2%), 16 with telmisartan (12.5%), 14 with losartan (10.9%), 10 with irbesartan (7.8%) and 3 with eprosartan (2.3%). Proportions of ARB-treated patients, who were diagnosed with unspecified IM, by year are very low, ranging from 0% to 0.05% and showing no relevant differences between molecules. The average time (days) elapsed from the last prescription of the reference treatment during the year following the Index Date to IM diagnosis was quite high, suggesting that patients did not stop their treatment after the IM diagnosis. Nevertheless, some treatment interruptions right after the IM diagnosis (minimum distance of 0 day) were identified in 6 out of 7 molecules.  Conclusions: Our findings suggest that ARB treatment is rarely associated to IM. Since there are no relevant differences between the IM incidences amongst the members of this class of drugs, this adverse event appears not to be molecule-dependent but rather class-dependent. PGI2 Dose Escalation of Biologics in Crohn’s Disease: Summary of Observational Studies in the UK Worbes-Cerezo M1, Lee XY2, Lelli F3, Bereza BG4, Einarson TR4 UK, High Wycombe, UK, 2Janssen-Cilag A/S, Birkerød, Denmark, 3Janssen-Cilag SpA, Cologno Monzese (MI), Italy, 4University of Toronto, Toronto, ON, Canada

1Janssen-Cilag

Objectives: Biologic therapies used to treat Crohn’s disease (CD) may lose their effect over time, requiring dose escalation. Practitioners and decision makers need such information, which is presently scarce. We summarized published rates of dose escalation in observational studies of CD in adults treated in the United Kingdom.  Methods: Two independent reviewers searched Medline, Embase and proceedings from four major gastroenterology meetings from 1990-2015, hand searching references and relevant UK sites. We accepted full peer-reviewed articles, peer-reviewed abstracts of oral/poster presentations at scientific congresses, or audits. No restrictions were placed on publication date or language. Patients could be treated with any biologic with or without adjunctive therapy for any duration. Required data included number of patients treated, drug(s) used, treatment regimens, numbers or rates requiring dose escalation and proportions receiving co-medications. Data were tabulated and summarized descriptively. Results: Thirteen publications were accepted for analysis, including ten full peer-reviewed articles, two poster abstracts and one audit. A total of 5,358 patients from across the UK were treated, mainly in referral centres; 51% were females and 49% males. Average age was 34.2 years; duration of CD was 6.4 years. Five publications (38%) reported on adalimumab, 3 (23%) on infliximab and 5 (38%) combined both drugs. No observational studies from the UK were found that examined vedolizumab. 73% of the patients analysed received therapy as first line biologic treatment, 15% second line and 12% did not report prior exposure. The overall rate of dose escalation was 12%; 19% in those treated with adalimumab and 8% with infliximab, after an average of 8.4 months. Doses were escalated in 7% of those receiving first line treatment (adalimumab 8%, infliximab 7%), and 22% for second line (all adalimumab); 59% of patients were administered co-medications.  Conclusions: An appreciable proportion requires dose escalation, which increases by treatment line.

PGI3 Effectiveness of Antiviral Therapy for Genotype 1 Chronic Hepatitis C in Real-World Patients from the Valencian Community (Spain) Buigues-Pastor L1, Ventura-Cerdá JM2, Lacruz-Gimeno P2, Saurí-Ferrer MI2, Vivas-Consuelo D1 1Universitat Politècnica de València (UPV), Valencia, Spain, 2General Directorate for Pharmacy and Healthcare Products, Valencia, Spain

Objectives: To complement the existing studies about effectiveness of antiviral therapy for genotype 1 chronic hepatitis C by using real-world

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patients.  Methods: The effectiveness was analyzed using the healthcare database owned by the valencian regional government (Conselleria de Sanitat Universal i Salut Pública) in Spain. This database contains information about 5 million people. The data was filtered in order to obtain patients with antiviral therapy for genotype 1 chronic hepatitis C those had available information about their viral load twelve weeks after completing treatment. The time period considered was from January to August, 2015.  Results: 902 patients were identified. 871 (97%) had no detectable HCV viral load twelve weeks after completing treatment. The effectiveness by treatment was: 98.78% for combination ledipasvir-sofosbuvir (246 patients treated); 94.54% for combination ledipasvir-sofosbuvir-ribavirin (183 patients treated); 91.82% for combination sofosbuvir-simeprevir-ribavirin (159 patients treated); 100% for sofosbuvir-simeprevir (114 patients treated); 100.00% for ombitasvir-paritaprevir-ritonavir-dasabuvir (79 patients treated); 100.00% for ombitasvir-paritaprevir-ritonavir-dasabuvir-ribavirin (77 patients treated); 93.10% for sofosbuvir-daclatasvir-ribavirin (29 patients treated); 100% for sofosbuvir-daclatasvir (8 patients treated); 50% for simeprevir-ribavirin (4 patients treated); 50.00% for sofosbuvir-ribavirin (2 patients treated); and 100.00% for ombitasvir-paritaprevir-ritonavir (1 patient treated). Genotype distribution was: 34% of patients with genotype 1a and 66% of patients with genotype 1b infection. Fibrosis (FIB) stage distribution was: 1.55% FIB0; 2.33% FIB1; 17.18% FIB2; 23.28% FIB3 and 55.65% FIB4.  Conclusions: The analysis using real-world patients confirms the high effectiveness of antiviral therapy for genotype 1 chronic hepatitis C. The results indicate that therapies mostly used are ledipasvir-sofosbuvir and ledispasvir-sofosbuvir-ribavirin. Therapies including sofosbuvir-simeprevir, sofosbuvir-daclatasvir, ombitasvir-paritaprevirritonavir-dasabuvir, ombitasvir-paritaprevir-ritonavir-dasabuvi-ribavirin and ombitasvir-paritaprevir-ritonavir achieve the 100% of effectiveness. The less effective therapy is the combination simeprevir-ribavirin and the combination sofosbuvir-ribavirin.

PGI4 HBSAG Seroclearance after Treatment-Induced HBEAG Seroclearance in Chronic Hepatitis B Patients in Beijing, China Wang L1, Cheng K1, Duan Z2, Chen Y2, Zhao X1, Xu M2, Wang Y1 of Medical Sciences, Peking Union Medical College, Beijing, China, 2Beijing You’ an Hospital of Capital Medical University, Beijing, China

1Chinese Academy

Objectives: To explore factors associated with hepatitis B surface antigen (HBsAg) seroclearance after treatment-induced hepatitis B e-antigen (HBeAg) seroclearance.  Methods: A total of 1,072 chronic hepatitis B (CHB) patients with treatmentinduced HBeAg seroclearance in 2008-2012 in Beijing You’an Hospital were enrolled and then followed up to April 30, 2016. Serum level of HBsAg, hepatitis B virus (HBV) DNA, anti-HBe and anti-virus therapy were collected and their relationships with subsequent HBsAg seroclearance were investigated.  Results: After 2,332.1 personyears’ follow-up, 75 patients underwent HBsAg seroclearance (3.2% annual seroclearance rate). Cox regression analysis showed serum HBsAg level, HBsAg reduction rates in 6 months and interferon usage were positively associated with HBsAg seroclearance after adjusting gender, age at HBeAg seroclearance, HBV DNA and status of anti-HBe. Compared with the patients with HBsAg level ≥ 1983.0 IU/mL, the HBsAg seroclearance rate was higher for those with HBsAg levels of 16.6-1983.0 IU/mL and < 16.6 IU/mL, with hazards ratio of 7.9 (95% CI: 4.3-14.6, P< 0.0001) and 71.8 (95% CI: 34.8-148.0, P< 0.0001). Patients with reduction rates of ≥  23% and interferon group had a higher likelihood of HBsAg seroclearance, with hazards ratio of 6.9 (95% CI: 3.6-13.0, P<0.0001) and 1.9 (95% CI: 1.1-3.3, P= 0.0212), respectively. HBsAg at HBeAg seroclearance predicted HBsAg seroclearance at 12, 24, 36 and 48 months with accuracy of 87.0%, 87.8%, 85.1% and 83.4%, respectively. Reduction rates of HBsAg in 6 months predicted HBsAg seroclearance with accuracy of 88.9%, 77.5%, 78.0% and 67.3%, respectively, at the above mentioned 4 time points.  Conclusions: The lower HBsAg level at HBeAg seroclearance, faster reduction rates of HBsAg in 6 months and interferon treatment after HBeAg seroclearance can predict HBsAg clearance for treatment-induced HBeAg seroclearance CHB patients.

PGI5 Real-World Treatment Patterns with Anti-Tumor Necrosis Factor Therapy in Inflammatory Bowel Disease in Israel Weil C1, Chodick G2, Yarden A3, Khalid JM4, Shalev V2 1Maccabi Healthcare Services, Tel Aviv, Israel, 2Maccabi Healthcare Services and Tel Aviv University, Tel Aviv, Israel, 3Takeda Israel Ltd., Petach Tikva, Israel, 4Takeda Development Centre Europe Ltd, London, UK

Objectives: To describe real-world treatment patterns with anti-tumor necrosis factor (anti-TNF) therapy among patients with inflammatory bowel disease (IBD) in a large health plan.  Methods: A retrospective cohort study was performed using the databases of Maccabi Healthcare Services (MHS), a 2-million-member non-profitmaking health plan in Israel. The study population included MHS members diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD), who initiated infliximab or adalimumab in 2010-2014 (index purchase). Treatment patterns in the first year were described, including discontinuation (defined as a treatment gap >  60 days), switching to a different biologic (also including golimumab, natalizumab and vedolizumab), dose escalation, and add-on therapy.  Results: The study population included n= 204 UC patients (mean age: 33.1 ±SD 15.1 years) and n= 729 CD patients (32.3 ± 14.9 years). Mean time from diagnosis to anti-TNF initiation was 5.4 ±4.9 years. Over ninety percent of UC patients had prior experience with both 5-aminosalicylic acid (5-ASA) and corticosteroids (CS), compared to 63% of CD patients. Prior use of immunomodulators (IM) was comparable between the groups (approximately 80%). At 12 months from index purchase, 59% of patients persisted with their initial biologic therapy (of them, 10% had anti-TNF dose escalation), and 12% switched biologic. Add-on therapy was more frequent in UC (58%) patients compared to CD (44%).  Conclusions: The study results indicate that a substantial proportion of CD