TOUCH™ Study Patient Outcomes: Workforce Participation, Productivity and the Impact of Natalizumab

Abstract

Purpose: Natalizumab (NAT) is approved for the treatment of moderate to severe Crohn's disease (CD) in patients who have had an inadequate response to or are unable to tolerate conventional and anti-TNF therapies. In this naturalistic treatment experience study, the impact of NAT on a variety of outcomes is evaluated. Methods: The study sample was comprised of patients enrolled in the Tysabri Outreach: Unified Commitment to Health (TOUCH™) prescribing program that were apprised of the project and agreed to study participation. Subjects completed online or phone surveys containing the Health-Related Productivity Questionnaire (HRPQ). The HRPQ collects data on absenteeism and presenteeism (reduced productivity during the performance of work) in the workplace and at home and the impact of disease on current and past workforce participation. Data were collected prior to the initiation of NAT therapy and at month 3 of treatment. Results: To date, forty-nine patients have provided baseline data (Females= 59%, mean age=41 years, mean time from diagnosis=13 years). At baseline 38.8% of the patients were employed, 24.5% full-time and 14.3% part-time. Since CD symptoms first developed, 46.9% of patients reported that CD had forced them to be unemployed when they wanted to work full-time (mean duration 3.7 years). Equal percentages of patients (26.5%) had been forced to be unemployed when they wanted to be employed part-time (mean duration 1.0 years) or to work part-time when they wanted to work full-time (mean duration 2.9 years). Among the employed subjects (n=18), 49.0% of their scheduled hours of employed work were lost due to CD (absenteeism= 16.4%, presenteeism=32.6%). Among the 13 patients for whom home productivity data were available at follow-up, the percent of planned work lost due to absenteeism was reduced by about two-thirds (47.9% vs. 16.4%, p=0.016) and the total % of planned hours lost was reduced by about 50% (60.6% vs. 31.5%, p=0.037). There was an insignificant increase in the % of planned home work activity lost due to presenteeism (12.7% vs. 15.1%, p=0.763). Conclusion: Among the employed NAT patients, approximately half of their scheduled hours of employed work were lost due to CD at the baseline measurement. Adequate patient numbers were available to allow an evaluation of the change in home work productivity associated with NAT therapy. In that setting there was a statistically significant reduction in the total percentage of hours of productivity lost from 60.6% to 31.5%. Patients initiating therapy with NAT have low rates of workforce participation due to CD and have, on average, experienced protracted periods of disruption in their ability to be employed since their CD developed. Disclosure: Dr Rubin reports serving as a consultant and an Advisory Committee/ Board Member to Elan and Biogen Idec; Dr Lewis reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Kane reports having received Grant/Research Support and serving as an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Panaccione reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Colombel reports serving as a consultant and an Advisory Committee/ Board Member to Elan and Biogen Idec; Dr Sands reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Hass, Ms. Nag and Mr Panjabi are employees of Elan. These studies were supported by Elan Pharmaceuticals, Inc. and Biogen Idec, Inc.