Intravenous Versus Subcutaneous Anti-TNF-Alpha Agents for Crohn's Disease: A Comparison of Effectiveness and Safety.

BACKGROUND: In recent years, there have been a number of pharmacological innovations for Crohn's disease (CD), a difficult-to-treat condition, including new treatment philosophies (e.g., top-down therapy) and new therapeutic options in terms of the agent and the route of administration. Three anti-tumor necrosis factor (anti-TNF-alpha) agents are available for use among CD patients in the United States: infliximab, an intravenous agent, and adalimumab and certolizumab pegol, 2 newer subcutaneous products. Infliximab is considered the "gold standard" because it has the longest clinical experience, and adalimumab and certolizumab pegol have each gained significant market share. OBJECTIVE: To examine differences in effectiveness and safety between currently available intravenous and subcutaneous anti-TNF-alpha agents used to treat patients with CD. METHODS: Data for this retrospective, administrative claims analysis were obtained from pharmacy and medical claims from major U.S. health plans geographically dispersed across 14 states during 2007-2011. Patients had at least 1 ICD-9-CM diagnosis for CD, 6 months pre-index eligibility, and initiated anti-TNF-alpha therapy on the index date. Patients in each cohort were propensity score matched on pre-index demographics, clinical characteristics, and baseline health care use. During the post-index period, age-sex adjusted incidence rate ratios (IRRs) of CD-related symptoms, infections, cancers, and hepatic-related conditions were compared using Cox (PH) models. RESULTS: The matched cohorts included 515 patients in each group, with an average age of 39 years. Median follow-up was 17.5 months in the intravenous cohort and 17.7 months in the subcutaneous cohort. In terms of effectiveness outcomes, age-sex adjusted IRRs for the subcutaneous group, with the intravenous cohort as a reference, were as follows: 0.61 (95% CI = 0.32-1.18, P = 0.14) for anal fissures; 0.97 (95% CI = 0.72-1.30, P = 0.85) for abscess; 1.08 (95% CI = 0.79-1.04, P = 0.64) for fistulas; 1.12 (95% CI = 0.83-1.54, P = 0.45) for gastrointestinal hemorrhage; and 1.22 (95% CI = 0.93-1.59, P = 0.14) for a combined measure of obstruction, occlusion, stenosis, and stricture of intestine. In terms of safety outcomes, age-sex adjusted IRRs for the subcutaneous group were as follows: 0.85 (95% CI = 0.62-1.16, P = 0.30) for infections; 1.16 (95% CI = 0.71-1.89, P = 0.55) for cancers; and 1.23 (95% CI = 0.79-1.92, P = 0.35) for hepatic-related conditions. CONCLUSIONS: After adjusting for baseline characteristics, effectiveness and safety outcomes appear to be comparable between intravenous and subcutaneous anti-TNF-alpha agents in patients with CD. With similar outcomes, other considerations such as convenience of administration and patient preference may play a more prominent role in choice of agent. Health care providers and health payers should inform CD patients about the range of options available when selecting an anti-TNF-alpha agent.

Considering patient preferences when selecting anti-tumor necrosis factor therapeutic options.

BACKGROUND: Anti-tumor necrosis factor (TNF) medications for the treatment of chronic inflammatory conditions represent a large and growing expenditure for health plans. Over the past few years, there has been an increase in options for patients receiving anti-TNFs, including choice of agent, route of administration, and location for receiving the medication. OBJECTIVE: To examine patient preferences regarding available anti-TNF agents and mode of administration options. METHODS: This cross-sectional survey and claims study was based on administrative claims in the HealthCore Integrated Research Database. Patients were identified for this study if they were receiving infliximab (the intravenous [IV] group) or adalimumab, golimumab, etanercept, or certolizumab pegol (the subcutaneous [SC] group) between March 2012 and August 2012 and were diagnosed with conditions for which these agents are indicated by the US Food and Drug Administration. The survey questionnaire was developed specifically for this study. Participants were asked about their use of anti-TNF agents, locations of administration, preferences for IV or SC therapy, interest in anti-TNF home therapy options, and their physician's role in their decision-making process. A validated instrument, the Treatment Satisfaction Questionnaire for Medication (TSQM) version II, was used to assess treatment satisfaction by the patients. RESULTS: A total of 6000 patients were included in the final list of patients, and the study was stopped when the targeted number of 500 surveys were completed. The IV group consisted of 202 (40%) patients, and the SC group consisted of 298 (60%) patients. Patients in the SC group had a higher preference for the administration route they were using compared with patients in the IV group: 89.9% of the SC group preferred the SC route of administration, whereas 71.8% of the IV group preferred the IV route (P <.001). The global treatment satisfaction scores were similar in both groups (81.9 in the IV group, 80.1 in the SC group; P = .247). The reported likelihood of patients discussing alternative anti-TNF options with their physician was low (45.5% in the IV group vs 49.7% in the SC group; P = .366). CONCLUSIONS: When asked to make a hypothetical choice between IV and SC administration, patients had stronger preferences for SC routes than for IV routes. There was a strong correlation between the route of administration in use and the preference, indicating high level of satisfaction with the current treatment used, which was confirmed with the TSQM version II results. An opportunity for patient education exists, because conversations with physicians about alternative anti-TNF therapies and administration appear to be lacking.