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Background Treatment persistence is an important consideration when selecting a therapy for chronic conditions such as rheumatoid arthritis (RA). We assessed the long-term persistence of abatacept or a tumor necrosis factor inhibitor (TNFi) following (1) inadequate response to a conventional synthetic disease-modifying antirheumatic drug (first-line biologic agent) and (2) inadequate response to a first biologic DMARD (second-line biologic agent). Methods Data were extracted from the Rhumadata® registry for patients with RA prescribed either abatacept or a TNFi (adalimumab, certolizumab, etanercept, golimumab, or infliximab) who met the study selection criteria. The primary outcome was persistence to abatacept and TNFi treatment, as first- or second-line biologics. Secondary outcomes included the proportion of patients discontinuing therapy, reasons for discontinuation, and predictors of discontinuation. Persistence was defined as the time from initiation to discontinuation of biologic therapy. Baseline characteristics were compared using descriptive statistics; cumulative persistence rates were estimated using Kaplan-Meier methods, compared using the log-rank test. Multivariate Cox proportional hazard models were used to compare the persistence between treatments, controlling for baseline covariates. Results Overall, 705 patients met the selection criteria for first-line biologic agent initiation (abatacept, n = 92; TNFi, n = 613) and 317 patients met the criteria for second-line biologic agent initiation (abatacept, n = 105; TNFi, n = 212). There were no clinically significant differences in baseline characteristics between the treatments with either first- or second-line biologics. Persistence was similar between the first-line biologic treatments ( p = 0.7406) but significantly higher for abatacept compared with TNFi as a second-line biologic ( p = 0.0001). Mean (SD) times on first-line biologic abatacept and TNFi use were 4.53 (0.41) and 5.35 (0.20) years, and 4.80 (0.45) and 2.82 (0.24) years, respectively, as second-line biologic agents. The proportion of patients discontinuing abatacept and TNFi in first-line was 51.1% vs. 59.5% ( p = 0.1404), respectively. In second-line, it was 57.1% vs. 74.1% ( p = 0.0031). The main reasons for stopping both treatments were inefficacy and adverse events. Conclusions Abatacept and TNFi use demonstrated similar persistence rates at 9 years as a first-line biologic agent. As a second-line biologic agent, abatacept had better persistence rates over a TNFi.

BackgroundThere is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. The Named Patient Program in Europe included patients with advanced chronic hepatitis C, a life expectancy of less than 12 months and no other treatment options.MethodsA retrospective multi-country cohort of patients with chronic hepatitis C who received daclatasvir as part of the Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland and the United Kingdom. Treatment response was defined as a sustained virologic response (unquantifiable hepatitis C RNA) at 12 weeks post treatment. We summarised the characteristics of the patients in this cohort and estimated the rate of sustained virologic response for patients receiving daclatasvir and sofosbuvir with or without ribavirin using hierarchical Bayesian modelling.ResultsThe 249 patients included had a median age of 56 years; most were male (78%), hepatitis C genotype 1 (75%), treatment experienced (65%) and with decompensated cirrhosis (59%). Many had had a liver transplant before receiving daclatasvir (40%). Of the 249 patients, 242 patients received daclatasvir and sofosbuvir and either reached 12 weeks post treatment or died during (n = 9) or after treatment (n = 4) or were lost to follow up during treatment (n = 1). The estimated rate of sustained virologic response at 12 weeks post treatment was 87% (95% credible interval 75 to 94%) for previously treated genotype 1 patients with decompensated cirrhosis.ConclusionsDaclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-2106-x) contains supplementary material, which is available to authorized users.

BackgroundStudies have reported that the presence of elevated anti-citrullinated protein antibodies (ACPA)/RF levels, together with joint erosions, is associated with higher disease burden in terms of disability, and mortality in rheumatoid arthritis (RA). Abatacept has been shown to be effective in this patient population with favorable comparative data against adalimumab.(1) However, few studies have investigated the cost effectiveness of abatacept in this population to similar treatments such as TNFs.ObjectivesThe objective of the study was to compare the cost-effectiveness of abatacept to adalimumab as a first bDMARD in ACPA positive RA patients who failed treatment with methotrexate (MTX) in Germany.MethodsA decision tree model was used to estimate the cost-effectiveness, from a payer's perspective, of different treatment sequences in RA over a two year time frame. The effectiveness criteria were defined as achieving the treatment target measured by the Disease Activity Score 28 (DAS28 (CRP)<2.6; “remission”). A treatment switch to a different biologic as 2nd line and 3rd line bDMARD was allowed -in case of not achieving remission with therapy- every 6 months over a two year time period. Effectiveness data was based on randomized controlled trials (RCT) identified by an updated previous systematic literature search by the Institute for Quality and Efficiency in Health Care (IQWiG). Costs of medication and other direct medical costs were taken from a recent publication (2) and included in the analysis. Cost-effectiveness of RA treatment was investigated in ACPA positive patients in this study and presented as overall costs per day in remission. To manage uncertainty in the model, a fully probabilistic approach was used with 10,000 runs.ResultsFor ACPA positive patients, treatment strategies including early treatment with abatacept had lower total costs per clinical outcome compared to later use. Figure 1 summarizes the costs per day in remission for the treatment sequences investigated: treatment sequences starting with abatacept resulted in lower costs for reaching remission (mean 330 €/day, range 328 €-333 €/day) compared to sequences starting with adalimumab (mean 384 €/day, range 378 €-390 €/day). Choice of the second or third biologic in the treatment sequences appears to have little impact on the costs per outcome.ConclusionsThe results of this analysis suggest that in ACPA positive RA patients treatment with abatacept appears to be more cost-effective compared to treatment with adalimumab as a first bDMARD.References Sokolove J, Schiff M, Fleischmann R, et al. Annals of the rheumatic diseases. 2016 Apr;75(4):709–14.Beresniak A, Baerwald C, Zeidler H et al. Clin Exp Rheumatol. 2013 May-Jun;31(3):400–8. Disclosure of InterestA. Neubauer Grant/research support from: BMS, Intercept, Roche, Santen, C. Minartz Grant/research support from: BMS, Intercept, Roche, K. Herrmann Employee of: BMS, R. Postema Employee of: BMS, C. Baerwald Grant/research support from: Abbvie, Biogen, BMS, Chugai, Hexal, Medac, Pfizer,...