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P319 Adalimumab long-term effectiveness in adults with Crohn's Disease: Observational data from the PYRAMID registry

E.V. Loftus Jr*1, G. D'Haens2, W. Reinisch3, 4, J. Satsangi5, R. Panaccione6, R. Thakkar7, S. Eichner8, K. Wallace9, A. Deshmukh10, S. Wang11, M. Skup11, J. Chao11, Y. Bao11

1Mayo Clinic, Division of Gastroenterology & Hepatology, Rochester, United States, 2Academic Medical Center, Gastroenterology, Amsterdam, Netherlands, 3Medical University of Vienna, Internal Medicine, Vienna, Austria, 4McMaster University, Internal Medicine, Hamilton, Canada, 5Western General Hospital, Edinburgh, United Kingdom, 6University of Calgary, Medicine, Calgary, Canada, 7AbbVie Inc., Global Pharmaceutical Research & Development , North Chicago, IL, United States, 8AbbVie Inc., Global Medical Affairs, North Chicago, IL, United States, 9AbbVie Inc., Immunology/Gastroenterology, North Chicago, IL, United States, 10AbbVie Inc., Statistics, North Chicago, IL, United States, 11AbbVie Inc., Global Health Economics and Outcomes Research, North Chicago, IL, United States

Background

To evaluate the long-term effectiveness of adalimumab (ADA), an anti-tumour necrosis factor agent approved for the treatment of moderate to severe Crohn's disease (CD).

Methods

Five years of interim data from PYRAMID, an ongoing, global, observational registry initiated in 2007, were used to evaluate the long-term effectiveness of ADA as measured in the change from baseline in Physician's Global Assessment (PGA; a composite of the Harvey-Bradshaw Index and a rectal bleeding score); Short Inflammatory Bowel Disease Questionnaire (SIBDQ); and 4 components of the Work Productivity and Activity Impairment Questionnaire (WPAI): absenteeism, presenteeism, total work productivity impairment (TWPI), and total activity impairment (TAI). A score increase indicates improvement for SIBDQ; a score decrease indicates improvement for all other effectiveness measures. ADA was prescribed according to local product labels. Effectiveness Results were summarised with descriptive statistics for patients naïve to ADA at enrolment. Only observed effectiveness parameters were to be analysed. No missing data imputations were to be performed.

Effectiveness Measures for ADA-naïve Patients

Measure1 year2 yearsChange From Baseline4 years5 years
BaselineMean (SD)
Mean (SD)3 years
PGA8.1 (5.6) n=2,004-3.6 (5.4) n=1,336-3.7 (5.5) n=1,124-4.2 (5.3) n=1,032-4.1 (5.1) n=847-4.4 (5.1) n=232
SIBDQ40.5 (12.7) n=1,45711.6 (13.0) n=72310.8 (14.3) n=52611.8 (13.6) n=44112.3 (13.3) n=36113.2 (13.0) n=108
Absenteeism21.9 (33.3) n=825-11.9 (34.9) n=330-10.6 (32.7) n=227-15.0 (34.7) n=186-11.4 (36.7) n=154-12.3 (31.4) n=40
Presenteeism41.4 (29.9) n=855-19.6 (32.5) n=353-20.1 (35.2) n=259-22.4 (33.2) n=208-17.8 (37.1) n=167-22.9 (28.9) n=42
TWPI50.2 (33.3) n=823-23.8 (35.1) n=326-23.7 (38.9) n=224-27.3 (35.6) n=181-22.2 (37.8) n=153-21.9 (30.4) n=39
TAI50.7 (30.0) n=1,421-23.0 (31.7) n=698-23.3 (34.3) n=513-23.6 (32.8) n=422-22.6 (34.0) n=345-26.6 (29.3) n=97

Results

As of December 2013, 5,061 patients have been enrolled. Of these, 41% (2,092/5,061) were ADA-naïve at enrolment. The mean age for ADA-naïve patients was 37 years, mean CD duration was 10 years, 58% were female, and 96% were white. Mean PGA scores improved from baseline and were maintained through year 5. Clinically meaningful improvements in mean scores for SIBDQ and WPAI (absenteeism, presenteeism, TWPI, and TAI) were maintained over 5 years (Table).

Conclusion

This international observational study of ADA use in routine clinical practice demonstrated that clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in patients with CD 1 year after initiating ADA. These improvements were maintained over a 5-year period.