Background/Purpose:

Non-interventional studies (NIS) are essential instruments in pharmaceutical research not only for pharmaceutical companies but also for regulatory authorities or reimbursement bodies in Germany.
Aside from direct costs caused by a disease, German sick funds as well as health authorities have a keen interest in indirect costs, such as costs derived from loss of work productivity.

Methods:

As primary endpoint, the change of work productivity impairment and ability for daily activities in month 3 (V1) vs baseline visit (V0) was evaluated.
All 4 subscores of the WPAI were analysed: disease related absence from work (absenteeism), working while sick (presenteeism), total work productivity impairment (TWPI) and activity impairment with TWPI as primary score.
In addition, an evaluation of the activity impairment in the mITT population (modified-Intention-To-Treat) was performed.
For the secondary analysis of the primary endpoint, the change in work productivity/activity impairment after 6 months and 12 months vs baseline as measured by WPAI for PsA, RA and AS pts treated with Golimumab (GLM) in German clinical practice was evaluated.

Results:

Of 748 pts (100%) who started treatment with GLM at V0 (baseline), 666 (89.0%), 634 (84.8%) and 552 pts (73.8%) continued treatment until V1 (Mo 3), V2 (Mo 6), and V3 (Mo 12/end of observation period), respectively.
Efficacy analyses were performed on the mITT population which included 700 pts (RA=237, PsA=235, AS=228) who had at least 2 documented visits.
The primary efficacy endpoint was analyzed in the mITT subset of 493 pts (RA=158, PsA=157, AS=178) with full-time or part-time employment at baseline (mITTe).
The statistically significant improvements in the mean WPAI domain scores were maintained over the 12-month observation period in all 3 indications with a higher treatment effect regarding “activity impairment” and “presenteeism” than with “absenteeism” (Table 1). The magnitude of improvements in the 4 WPAI domains and the time course of improvements varied between the underlying disease (RA, PsA, AS).
In general, the improvements in the 4 WPAI domains were greater in pts with AS and PsA compared to RA. A continuous improvement over time was seen in AS pts regarding the domain “activity impairment (Table 1). A positive effect of pre-treatment with biologics (i.e. better improvement in WPAI) was seen in RA pts for 3 domains (TWPI, absenteeism, presenteeism), and in PsA pts for 2 domains (absenteeism, activity impairment).

Conclusion:

GLM s. c. 1 x monthly is an effective treatment in pts with RA, AS and PsA.
All scores of the WPAI showed a significant (p< 0.05) reduction in mean score values in each indication.
GLM leads to an improvement of work productivity and daily activities in all pts already within the first 3 months of treatment and provided sustained improvement in WPAI in pts with RA, PsA and AS.

Table 1:          

WPAI – Changes in the 4 domain scores from baseline to Months 3, 6 and 12 (mITTe)