Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
The Effects of Low Dose Etanercept on Disease Control and Radiographic Progression in Moderate to Severe Rheumatoid Arthritis.
Raffeiner1, Bernd, Botsios2, Costantino, Sfriso2, Paolo, Ometto2, Francesca, Bernardi2, Livio, Todesco2, Silvano, Punzi2, Leonardo
Rheumatoid arthritis (RA) remains a socio-economic emergency: 100 billions of Euros were spent in 2006 for the disease in the USA and Europe. RA leads to disability, work loss and premature death. Biologics changed history of disease and patients' outcome. To justify elevated treatment costs biologics have been proved for cost-effectiveness. Some attempts are reported to reduce treatment costs. Etanercept (ETA) neutralizes TNFa with 20-fold higher potency than do other inhibitors at low concentrations of TNFa as for disease in remission. ETA appears suitable for dose reduction once patients gained remission.
Objectives of the Study:
To elucidate efficacy of low dose ETA to maintain remission. To compare radiological progression and safety of low with standard dose. To estimate cost savings of low dose ETA strategy.
Material and Methods:
Prospective observational study was performed on consecutive RA patients in DAS28 remission since 12 months by standard dose ETA from January 2004 to December 2009. Patients continued low (25 mg weekly) or standard dose ETA as follows: 56 with severe and 53 with moderate disease activity prior biologic continued with low dose ETA, 54 patients with severe and 54 with moderate activity standard dose. Patients were monitored every three months. Patients who failed dose reduction returned to full dose once remission was lost. Kaplan Meier survival curve was calculated for low dose patients. Modified Sharp score/van der Heijde (TSS) was performed on x-rays at baseline and after one year. Progression was reported as absolute DTSS >0 and as real progression DTSS >=5 according to the smallest detectable difference of the method. Progression prior to biologic was estimated for each patient using preceding X-rays. Incidence of infections was calculated by Mid-P exact test modified by Miettinen. Cost savings of low dose strategy were calculated based on national pricing including tax. All comparisons were controlled for statistical significance by Mann-Withney or exact Fisher test.
Between low and standard dose patients for both severe and moderate disease no differences for age, sex, disease duration, positivity for auto-antibodies, concomitant and past therapy, HAQ and DTSS/year were found. Severe groups resulted more aggressive from x-rays than moderate groups and were treated more likely with concomitant DMARDs. Up to now 89 patients (81,6%) maintained remission with low dose for a mean of 2.59 years. Patients failing dose reduction regained remission with full dose except one. Success was higher in younger patients taking less symptomatic, but was not different between severe and moderate groups. Radiological progression occurred only in a minority of patients in low dose ETA: DTSS >0 in 13.6% and DTSS >=5 in 0.8% of cases. Capability to arrest radiological progression was identical in low and standard dose and in patients who failed dose reduction. Low dose patients had fewer infections. Low dose ETA strategy produced costs savings of [euro]1,583,273 since its introduction, and continues to save [euro]562,071 per year.
Low dose ETA sustains clinical and radiological remission. Low dose strategy is safe and produces notable cost savings.
To cite this abstract, please use the following information:
Raffeiner, Bernd, Botsios, Costantino, Sfriso, Paolo, Ometto, Francesca, Bernardi, Livio, Todesco, Silvano, et al; The Effects of Low Dose Etanercept on Disease Control and Radiographic Progression in Moderate to Severe Rheumatoid Arthritis. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :290