Background/Purpose: Adalimumab (ADA) treated rheumatoid
arthritis (RA) patients (pts) are offered patient support programs (PSP) to manage
their disease. The purpose of this study is to assess the impact of PSP utilization
on clinical outcomes of ADA treated RA pts and examine the predictors of PSP utilization
among pts in clinical settings.

Methods: This is a post-hoc analysis based on
interim data from PASSION (NCT01383421); a post-marketing observational study of
pts with moderate to severe RA with an insufficient response to ≥1
disease-modifying antirheumatic drug (DMARD) and initiated ADA at participating
sites in the EU, Israel, Mexico, Puerto Rico, and Australia. Pts had to be ADA-naïve
and treated with ≤1 prior biologic DMARD. Pts were prescribed ADA
according to the local product label and had an option to utilize the PSP while
participating in the study. The elements of PSP comprised of starter pack, call
center/hotline, nursing services, educational material, injection guide, refill
reminders, email, newsletters, support groups, home delivery, and financial
assistance. Using multiple regression analysis DAS28, SDAI, and CDAI (mean change
at week 52 from baseline [BL]) were compared between PSP-users and PSP non-users
from 1-year time-horizon, after adjusting for the pts demographics (age,
gender, race) and clinical characteristics (RA duration , prior biologic DMARD
use, HAQ-DI, TJC28, SJC28, CRP [mg/l])  at the  BL. In a separate multivariate
logistic regression analysis, the following variables were assessed as the
predictors of PSP usage among ADA treated RA pts: age, race, gender, RA duration
, BL DAS28(CRP), BL HAQ-DI, prior biologic DMARD use, and PAM-13 level.

Results: A Total of 852 pts were included in
this analysis of which 49.9% were PSP-users while treated with ADA. The mean
age at BL was 54.1 y; 76.1% were female, and the mean duration of RA was 7.8 y.
Mean BL disease scores were 5.3 for DAS28(CRP), 35.8 for SDAI, and 33.4 for CDAI.
Prior biologic DMARD exposure was 17.4%. As shown in the figure, after
adjusting for pts BL demographics and clinical characteristics, significant higher
improvements  (P≤0.005) from BL to wk 52 were observed for PSP-users
vs PSP non-users in DAS28(CRP), SDAI, and CDAI  scores. Independent predictors
of PSP utilization were found to be: white race (3.856, [2.092, 7.108]), male
gender (0.630, [0.426,
0.934]),
higher BL HAQ (1.321,
[1.019, 1.717]) and DAS28 (1.016, [1.016, 1.379]) values and use of prior
biologic DMARD (2.331,
[1.484, 3.660]).

Conclusion: Moderate to severe RA pts who were
treated with ADA and used PSP showed significantly better clinical outcomes compared
to ADA treated PSP non-users. Several demographic and clinical characteristics independently
predicted PSP utilization. These findings indicate toward the potential role of
ADA PSP in better disease management among moderate to severe RA pts.