Background/Purpose:

Clinical trials have previously demonstrated that it is safe and effective for some rheumatoid arthritis (RA) patients with low disease activity on full dose Etanercept to switch to half dose Etanercept (25mg per week)¹. We decided to test the feasibility of this in clinical practice by developing a departmental Etanercept dose reduction algorithm. We also considered the associated cost savings.

Methods:

Patients with inflammatory rheumatic diseases were eligible to enter the treatment pathway provided they had been on full dose Etanercept for more than one year and had low disease activity according to two assessments at least one month apart (DAS 28 <3.2 for rheumatoid arthritis (RA), Bath Ankylosing Spondylitits Disease Activity Index (BASDAI) <4 for ankylosing spondylitis (AS) and zero tender/swollen joint for psoriatic arthritis (PSA)). After switching to half dose Etanercept, patients attended for clinical assessments at 1, 3 and 6 months. Patients were switched back to full dose Etanercept if they no longer met criteria for low disease activity (termed ‘flare’). Patients could choose to switch back to full dose Etanercept at any point without giving a reason.

Results:

31 patients (15 RA, 4 AS, 10 PSA, 1 adult JIA and 1 reactive arthritis) were switched to half dose Etanercept. Patient and disease criteria are shown in the table. 16 patients left the pathway early and had their dose increased for the following reasons: flare of disease (13), patient choice without objective evidence of flare (2) and device preference (1). After 6 months, 15 of the patients (48%) (9 RA, 3 AS, 2 PSA and 1 adult JIA) maintained low disease activity (see table) and so met criteria to continue on reduced dose Etanercept. A much smaller proportion of the patients with psoriatic arthritis (20%) maintained low disease activity compared with those with RA (60%). The total cost savings for the patients that completed 6 months on the pathway (90 patient-months) was $49,562 (£32,175). 

Conclusion:

We were able to reduce Etanercept dose for a large proportion of our patients with low disease activity and maintain low disease activity without flares of disease. This represented significant cost savings. When developing future guidance, national prescribing bodies could take this into account when determining the relative positioning for different biologic therapies.

Table: Patient Characteristics and Summary Data

	RA	AS	PSA	Other
Number of Patients	15	4	10	2
Gender (female)	11	0	2	1
Mean Age Yrs (SD)	56 (15)	50 (16)	48 (15)	32 and 22
Disease Duration Yrs (SD)	11 (6)	18 (19)	8 (5)	6.5
Concomitant DMARDS	MTX 9, HCQ 2, SSZ 1	None	3 MTX, 2 LFD, 1 ciclosporin	None
Duration Etanercept Yrs (SD) Pre Reduction	3.3 (2.0)	4.1 (1.8)	3 (0.9)	5.5
Mean Baseline Disease Activity (SD)	DAS 28: 2.5 (0.6)	BASDAI: 2.0 (0.4); Spinal VAS:1.1 (0.6)	All meeting criteria	Clinician remission
Mean Disease Activity (SD) at 6 months (of those remaining	DAS 28: 2.1 (1.2)	BASDAI:      0.9 (1.3) Spinal VAS: 0.0 (0.0)	All meeting criteria	Clinical Remission
Mean Time (months) to Exit Pathway (For Those Exiting)	1.8 (1.3)	1	1.8	2
Number Completing 6 months	9	3	2	1

Reference:

1) Smolen, Josef S. “L1-Low Disease Activity or Remission Induction with Etanercept 50 Mg and Methotrexate in Moderately Active Rheumatoid Arthritis: Maintenance of Response and Safety of Etanercept 50 Mg, 25 Mg, or Placebo in Combination with Methotrexate in a Randomized Double-Blind Study.” (2011). ACR conference abstract.

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