Adherence rates and health care costs in Crohn's disease patients receiving certolizumab pegol with and without home health nurse assistance: results from a retrospective analysis of patient claims and home health nurse data.

BACKGROUND: Patient support programs have a positive effect on adherence to therapy. Certolizumab pegol (CZP) is a tumor necrosis factor antagonist for the treatment of Crohn's disease. OBJECTIVES: To assess, using real-world claims data, whether home health nurse assistance had an effect on patients' adherence to CZP and to measure its impact on health care use and costs. METHODS: A retrospective analysis of medical and pharmacy claims data from the IQVIA Real-World Data Adjudicated Claims Database was conducted using data from January 1, 2007 through September 30, 2015. CZP patients with Crohn's disease were eligible to receive self-administration instructions from a nurse or nurse-administered CZP injections, or both. These services were provided by CIMplicity®, a home health nurse program sponsored by UCB Pharma. Cohorts were based on patients with and without nurse assistance and were matched based on gender and categorical age. Adherence to CZP was determined using the medication possession ratio (MPR) and proportion of days covered (PDC). A Kaplan-Meier analysis was performed to compare time to discontinuation of CZP between the two cohorts. Multivariate regression analyses were performed, adjusting for additional covariates to compare the effect of CZP with and without nurse assistance on hospitalization and total health care costs. RESULTS: Patients with at least 12 months of continuous enrollment post-index date were evaluated for adherence to CZP (n=276 in each cohort). The mean and median PDC and MPR values were higher with nurse assistance than without. Time to discontinuation was significantly longer in patients who received CZP with nurse assistance than without (P=0.0004). Results from the multivariate analyses showed a significant reduction in all-cause hospitalization (-55.8%; P=0.0026) and total health care costs (-14.3%; P=0.0045) with nurse assistance. CONCLUSION: This analysis suggests that home health nurse assistance increases adherence to CZP and reduces health care costs in patients with Crohn's disease.

One-year risk of serious infection in patients treated with certolizumab pegol as compared with other TNF inhibitors in a real-world setting: data from a national U.S. rheumatoid arthritis registry.

BACKGROUND: Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U.S. RA cohort before and after using a methodological approach to minimize channeling bias. METHODS: Patients with RA enrolled in the Corrona registry, aged ≥ 18 years, initiating CZP or other TNFi (etanercept, adalimumab, golimumab, or infliximab) after May 1, 2009 (n = 6215 initiations), were followed for ≤ 12 months. A propensity score (PS) model was used to control for baseline characteristics associated with the probability of receiving CZP vs other TNFi. Incidence rate ratios (IRRs) of serious infectious events (SIEs), malignancies, and cardiovascular events (CVEs) in the CZP group vs other TNFi group were calculated with 95% CIs, before and after PS matching. RESULTS: Patients were more likely to initiate CZP later in the course of therapy than those initiating other TNFi. CZP initiators (n = 975) were older and had longer disease duration, more active disease, and greater disability than other TNFi initiators (n = 5240). After PS matching, there were no clinically important differences between CZP (n = 952) and other TNFi (n = 952). Before PS matching, CZP was associated with a greater incidence of SIEs (IRR 1.53 [95% CI 1.13, 2.05]). The risk of SIEs was not different between groups after PS matching (IRR 1.26 [95% CI 0.84, 1.90]). The 95% CI of the IRRs for malignancies or CVEs included unity, regardless of PS matching, suggesting no difference in risk between CZP and other TNFi. CONCLUSIONS: After using PS matching to minimize channeling bias and compare patients with a similar likelihood of receiving CZP or other TNFi, the 1-year risk of SIEs, malignancies, and CVEs was not distinguishable between the two groups.

Anti-tumor necrosis factor agents reduce corticosteroid use compared with azathioprine in patients with Crohn's disease.

BACKGROUND: Corticosteroids are effective for inducing remission of Crohn's disease, but should not be used long term due to risk of adverse events. Benefits of immunosuppressants (e.g., azathioprine) and anti tumor necrosis factor (anti-TNF) agents include reduced reliance on corticosteroid-based therapies and avoidance of corticosteroid-associated adverse events. Our aim was to evaluate corticosteroid-sparing effects in patients with Crohn's disease upon being newly initiated on an anti-TNFα agent or azathioprine. METHODS: An analysis of US patient claims data from January 2008 to October 2011 was conducted using Truven Health MarketScan Research databases. Corticosteroid-sparing within 12 and 24 months after initiation of an anti-TNF agent (adalimumab, certolizumab pegol, or infliximab) or azathioprine was evaluated. RESULTS: In total, 2900 patients received a prescription for corticosteroids within the 6 month period before the initiation of an anti-TNF agent (63%) or azathioprine (37%). When certolizumab pegol, infliximab, or adalimumab were collectively compared with azathioprine, patients initiated on an anti-TNF agent avoided further prescriptions for corticosteroids at a greater rate than patients receiving azathioprine at 12 (43% vs. 27%, respectively; P < 0.0001) and 24 months (33% vs. 23%, respectively; P = 0.028). Individually, all anti-TNF agents showed higher rates of corticosteroid-sparing compared with azathioprine at 12 (P < 0.0001-0.011), but not 24 months (P = 0.0086-0.24). Key limitations of this study include lack of data regarding disease severity, response and assumptions of improvement, and compliance. CONCLUSIONS: Patients with Crohn's disease were able to avoid new prescriptions for corticosteroids at a statistically higher rate when treated with an anti-TNF agent. These results demonstrate that the anti-TNF agents are superior to azathioprine for minimizing exposure to corticosteroids.