Impact of linaclotide treatment on work productivity and activity impairment in
adults with irritable bowel syndrome with constipation: results from 2
randomized, double-blind, placebo-controlled phase 3 trials.
Author(s): Buono JL(1), Tourkodimitris S(2), Sarocco P(3), Johnston JM(4), Carson RT(5).
Affiliation(s): Author information:
(1)Manager, Health Economics and Outcomes Research, Forest Research Institute, LLC,
a subsidiary of Actavis plc, Jersey City, NJ.
(2)Director, Biostatistics, Forest Research Institute, LLC, a subsidiary of Actavis
plc, Jersey City, NJ.
(3)Senior Director, Health Economics and Outcomes Research, Ironwood
Pharmaceuticals, Cambridge, MA, during this study.
(4)Senior Principal Clinical Scientist, Clinical Affairs, Ironwood Pharmaceuticals,
Cambridge, MA.
(5)Director, Health Economics and Outcomes Research, Forest Research Institute, LLC,
a subsidiary of Actavis plc, Jersey City, NJ.
Publication date & source: 2014, Am Health Drug Benefits. , 7(5):289-97
BACKGROUND: Irritable bowel syndrome with constipation (IBS-C), a chronic
functional gastrointestinal disorder, has been shown to negatively affect work
productivity and impair daily activity, resulting in a substantial burden for
patients and employers. Linaclotide is a first-in-class guanylate cyclase-C
agonist approved for the treatment of adults with IBS-C and chronic idiopathic
constipation in the United States.
OBJECTIVE: To analyze the impact of treatment with linaclotide on work
productivity and daily activity impairment in adults with IBS-C and estimate the
indirect costs associated with this condition.
METHODS: This was a post-hoc analysis of data on IBS-C-related work time missed
and work and activity impairment from 2 phase 3 clinical trials that assessed the
efficacy and safety of linaclotide therapy in adults with IBS-C. The Work
Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was
self-administered at baseline and at weeks 4, 8, and 12 during the 12-week
treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the
extended treatment period in Trial 2. An analysis of covariance was conducted to
assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Indirect costs were calculated by converting overall work productivity losses
into monetary values using the human capital cost approach.
RESULTS: Of the 1602 patients with IBS-C who were randomized in the 2 clinical
trials, 1555 (97.1%) completed a baseline and at least 1 postbaseline WPAI:IBS-C
assessment and were included in the analysis cohort; 1148 (71.7%) of these
patients were employed. Once-daily treatment with linaclotide significantly
reduced overall work productivity loss and daily activity impairment among
patients with IBS-C at all study weeks. From baseline to week 12, compared with
placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work
productivity loss by 6.1%, and daily activity impairment by 4.7% (all P <.01) and
led to a numerically greater decrease in absenteeism. From baseline to week 26,
compared with placebo, reductions with linaclotide were 5.9% for presenteeism,
7.5% for overall work productivity loss, and 6.7% for daily activity impairment
(all P <.05). Reductions in overall work productivity loss from baseline to week
26 translate to 103 hours to 156 hours annually and correspond to an avoided
overall work loss of $3209 to $4861 annually for an employee with IBS-C.
CONCLUSION: The results of this analysis indicate that appropriate treatment of
IBS-C with medications such as linaclotide can reduce work-related impairment
associated with IBS-C. In addition, IBS-C therapies that effectively manage this
chronic condition and improve employees' quality of life and work productivity
may represent significant cost-savings for employers in the form of avoided work
productivity losses.
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