Long-Term Drug Survival of TNF Inhibitor Therapy in RA Patients: A Systematic Review of European National Drug Registers

Objective. The present systematic review of RA registry data was undertaken to analyse the time on treatment of licensed TNF inhibitors in patients with RA in Europe. Methods. English language European registry studies comparing TNF inhibitors were searched using MEDLINE, Embase, Cochrane, and WHO: ICTRP up to 16 April 2012 and proceedings of three selected conferences held between 2010 and 2012. Pooled analysis was performed to determine drug survival rates for each TNF inhibitor. Results. Sixteen studies met the inclusion criteria, of which 11 studies assessed biologic-naive patients and five studies included a mixed population of biologic-naive and biologic pretreated patients. The overall effectiveness of TNF inhibitors diminished with time, leading to decreased drug survival rates. Pooled drug survival rates after 60 months follow-up were 37% (infliximab), 48% (adalimumab), and 52% (etanercept). Further, in an observational study, when TNF inhibitors were used in combination with methotrexate, a longer drug survival was observed compared to TNF inhibitors alone. Conclusion. The findings of this systematic review indicated numerically lower drug discontinuation rates with etanercept than adalimumab, whereas infliximab had the highest rate. Further research is needed to understand the underlying mechanisms of treatment discontinuation with TNF inhibitors

Efficacy of pharmacotherapies for short-term smoking abstinance: A systematic review and meta-analysis

Abstract Background Smoking cessation has important immediate health benefits. The comparative short-term effectiveness of smoking cessation interventions is not well known. We aimed to determine the relative effectiveness of nicotine replacement therapy (NRT), bupropion and varenicline at 4 weeks post-target quit date. Methods We searched 10 electronic medical databases (inception to October 2008). We selected randomized clinical trials [RCTs] evaluating interventions for our primary outcome of abstinence from smoking at at-least 4 weeks post-target quit date, with biochemical confirmation. We conducted random-effects odds ratio (OR) meta-analysis and meta-regression. We compared treatment effects across interventions using head-to-head trials and calculated indirect comparisons. Results We combined a total of 101 trials evaluating delivery of NRT versus inert controls at approximately 4 weeks post-target quit date (total n = 31,321). The pooled overall OR is OR 2.05 (95% Confidence Interval [CI], 1.89-2.23, P = Conclusion Pharmacotherapeutic interventions are effective for increasing smoking abstinence rates in the short-term.</p

Real World Data Analysis of Coagulation Factor IX Costs in Specific Patients with Hemophilia B Switching from Standard Half-Life to Extended Half-Life Products

Abstract Introduction: Hemophilia B, an X-linked genetic disease characterized by low clotting factor IX (FIX) levels, leads to spontaneous and traumatic bleeding in affected individuals. Intravenous FIX replenishment is administered to maintain adequate levels. The recent introduction of an extended half-life (EHL) FIX replacement product provided the opportunity to compare costs of care associated with treatment with an EHL product versus a standard half-life (SHL) product. Methods: The Truven Marketscan US claims database (Oct 2010 - Apr 2016) was used to identify factor concentrate charges for patients who had claims data for at least 3 months prior to and after switching from SHL to EHL products. Additionally, available data for up to 12 months pre- and post-switch on these identified patients were analyzed. Results: Thirteen patients, ranging from 3-64 years of age (median 18) were included in the analyses. Factor concentrate costs were higher after switch from SHL to EHL in each of the time periods examined (Table). Median costs were used since they were less influenced by isolated outliers and were similar to means in most cases. The median costs were 238% higher in the 3 months just after switching to the EHL product compared to the 3 months just prior to switching from the SHL product. Median costs were $51,881,$79,654, $75,695 and$61,515 in the 12-10, 9-7, 6-4 and 3-1 months prior to switch respectively compared to $173,515,$147,061, $149,971 and$207,973 in the corresponding quarterly month intervals post switch. Conclusion: This analysis of real world administrative data following individual patients through the switch from SHL to EHL products continuum suggests that switching from an SHL to an EHL product is associated with increased median factor costs throughout the 12 months following the switch, and that further analysis with larger numbers of patients should be explored. Disclosures Tortella: Pfizer Inc: Employment. Fogarty:Pfizer Inc: Employment. Alvir:Pfizer Inc: Employment. McDonald:Pfizer Inc: Employment. Spurden:Pfizer Inc: Employment. Pleil:Pfizer Inc: Employment. </jats:sec

Evaluating Patient Preference for Haemophilia a Treatment

Abstract INTRODUCTION: FuseNGo is a dual-chamber syringe for administering coagulation factor concentrate that was developed to reduce the number of steps and components necessary to reconstitute the drug product. This study aimed to assess patients' perception and preference for Haemophilia A (HA) using a recently developed questionnaire (HaemoPREF). The study also aimed to build on existing evidence for the construct validity of the HaemoPREF by evaluating the relationship between patient perception and preference for HA treatment, as assessed by the HaemoPREF, and associated factors including treatment satisfaction, quality of life (QoL), adherence, work productivity and activity impairment. METHODS: A non-interventional, cross-sectional, questionnaire completion study was conducted in Spain (n=31), Germany (n=10) and Italy (n=48). Adult HA patients were required to have used ReFacto AF with FuseNGo for at least 40 infusions. Spanish and German patients completed a web-based survey; Italian patients' data was collected on paper as part of a nested sub-study in an ongoing real-world study. Patients completed: HaemoPREF; Treatment Satisfaction Questionnaire for Medication (TSQM); VeritasPRO; Hemophilia Well-being Index (HWBI) and Work Productivity and Activity Impairment: Haemophilia Specific (WPAI + CIQ: HS). Correlational analyses, univariate and multivariate regression analyses aimed to examine the relationship between HaemoPREF and these instruments. RESULTS: Higher scores on the HaemoPREF indicate greater satisfaction with, or importance of, a concept. Scores are provided as a fraction of the theoretical range. The subscales with the greatest mean scores are 'Ease of Using Clotting Factor Treatment' (27.9/40); and 'Burden of Clotting Factor Treatment' (13.7/20) indicating high levels of satisfaction. The subscale with the lowest mean score is 'Influence of Others on Treatment Choices' (8.6/20). Scores on the TSQM indicated overall satisfaction with treatment, in particular the 'Treatment Global Satisfaction' subscale was high on average (72.5/100). The mean VeritasPRO global score indicated that the sample was moderately adherent overall. The mean score on the HWBI was 22.9/24, indicating patients do not consider their QoL to be negatively affected. On the WPAI the 'Overall Work Impairment' mean score was 23.1% while the 'Activity Impairment' mean score was 29.4% indicating low levels of work and activity impairment (Table 1). Spearman's correlations indicated the HaemoPREF global score had essentially a moderate relationship with the TSQM Treatment Global Satisfaction subscale (r=0.48), HWBI total score (r=0.41) and WPAI Activity Impairment score (r=0.39). Moderate correlations (≥0.40) were also noted between some of the HaemoPREF subscales. Some subscales on the TSQM, HWBI and WPAI. Correlations were low between the HaemoPREF and VeritasPRO (r=0.24) and the HaemoPREF and the WPAI Overall Work Impairment score (r=0.31) indicating the HaemoPREF is addressing something conceptually distinct to these measures. Multivariate regression on the pooled sample for the HaemoPREF global score (n=87) found the following variables were significant (p≤0.05) predictors of HaemoPREF global score: TSQM 'Treatment Convenience' (regression coefficient estimate: 0.5), VeritasPRO 'Timing' (regression coefficient estimate: 2.8), VeritasPRO 'Remembering' (regression coefficient estimate: 3.1), HWBI Total Score (regression coefficient estimate: 1.0) and site (Germany/Spain vs Italy, regression coefficient estimate: 13.0). CONCLUSIONS: These findings suggest that patients using ReFacto AF with FuseNGo are satisfied with and adherent to their treatment, and do not consider their QoL to be negatively affected. There is a moderate association between patient perception and preference for HA treatment, treatment satisfaction, adherence and QoL. This suggests while the HaemoPREF is related to, and assesses these components, it also measures distinct and important concepts not assessed by the other questionnaires completed by patients in the study. Thus, the HaemoPREF appears to fill a gap in the tools currently available to assess patient treatment experience in HA. Additional research in larger samples across multiple sites could further evaluate the relationship between the factors of interest. Disclosures Schulz: Pfizer Inc: Employment. Gordo:Pfizer Inc: Employment. Tolley:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Staunton:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Brohan:Adelphi Values: Other: full-time employee of Adelphi Values, who worked on this study as paid contractors to Pfizer Inc.. Spurden:Pfizer Inc: Employment. Cicchetti:Pfizer Inc: Other: paid consultant through Execupharm Inc. by Pfizer Inc.. Cappelleri:Pfizer Inc: Employment, Equity Ownership. </jats:sec

Predictors of real-world response in adults treated with botulinumtoxin-A for upper limb spasticity

Background: To explore predictors of treatment response in adults receiving botulinumtoxin-A (BoNT-A) for upper limb spasticity (ULS) and to describe the association between response and concomitant medication, professional physical therapy, and quality of life (QoL). Methods: This was a secondary analysis of the longitudinal Upper Limb International Spasticity study (ULIS-III) data set. Eligible patients were adults receiving/initiating BoNT-A treatment for ULS in clinical practice. The treatment response was a goal attainment scaling (GAS) T score change of ≥10 points from baseline to follow-up for each cycle. Concomitant medication was recorded. Time spent on professional physical therapy and self-management was recorded using the Upper Limb Focal Spasticity Therapy Recording (ULSTR) schedule. QoL was assessed using the EQ-5D-5L questionnaire. Baseline patient and clinical characteristics were described. Factors predictive of treatment response were explored using stepwise multivariable regression modeling (linear or logistic as appropriate for the outcome) and backward elimination (α=0.1). Results: Overall, 828/981 patients had response data; 71.9% responded to BoNT-A therapy. Potential predictors of response identified were the use of injection guidance techniques (P=0.001), female sex (P=0.031), and abobotulinumtoxin-A therapy (vs. onabotulinumtoxin-A; P&lt;0.001). Compared with nonresponders, responders had marginally lower use of concomitant medication, received marginally more professional physical therapy and (subgroup only) had improved QoL. Age, duration/distribution, severity of impairment, and previous BoNT-A had no predictive value. Conclusions: Future analyses of ULIS-III data will aim to validate these findings and further explore determinants of treatment response and the interplay between care modalities.</p