Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Achievement of a Patient Acceptable Symptom State (PASS) and of a Minimum Clinically Important Improvement (MCII) with Etanercept in Refractory Heel Enthesitis Related to Spondyloarthritis: Results of a Double Blind Placebo Controlled Study (HEEL)
Dougados1, M., Combe2, B., Braun3, J., Landewe4, R., Sibilia5, J., Cantagrel6, Alain, Leblanc7, V.
Hôpital Cochin and University of Paris. Paris, France,
Immuno-Rheumatology, Montpellier, France,
Rheumazentrum Ruhrgebiet, Herne, Germany,
Maastricht Univ Medical Ctr, Maastricht, Netherlands,
University Hospital of Strasbourg, Strasbourg, France,
JE 2510, Purpan University Hospital, Toulouse, France,
Wyeth Pharmaceuticals France
To investigate the short-term symptomatic efficacy of etanercept in chronic heel enthesitis related to spondyloarthritis (SpA)
Prospective, randomized, 12-week, placebo- controlled trial. Study treatments: etanercept 50 mg OW vs placebo. Patients: Adults, SpA (Amor criteria) with active and refractory heel enthesitis. Outcome variables: Apart from the conventional ones (e.g. visual pain [VAS scale 0100], function [WOMAC function sub-scale, normalized unit 0100]), the PASS concept was evaluated according to the following question: "If you were to remain in the next several months as you were during the last 48 hours, would this be acceptable for you?" and the MCII by "Compared to when you started the study, how have you been during the last 48 hours?" Such questions were asked at each visit after baseline. Statistical analysis: Time to reach a sustained PASS using the Kaplan Meier survival analysis and Log-Rank test; MCII using a GEE model.
Of the 24 enrolled patients (males: 67%, age: 37±12 y, B27 positive: 71%), 12 received etanercept and 12 placebo. Groups were comparable at baseline concerning symptomatic activity of the disease (patient's global: 70±17, heel pain: 68±16, functional impairment: 47±20). Estimated percentage of patients achieving a sustained PASS after 3 months was 50% vs 0% (p=0.0168) in the etanercept and placebo group respectively and such status was achieved as soon as the first 4 weeks of therapy. Statistically significant difference between etanercept and placebo was reported for the MCII at week 12 (75% versus 22.2% patients very or moderately improved, p=0.020).
This study, the first one using a prospective, placebo-controlled design in patients with active and refractory heel enthesitis demonstrated a symptomatic clinically relevant and statistically significant effect of etanercept. In addition it shows the achievement of another treatment goal such as PASS and MCII, addressing "therapeutic success" at patient level
This study was sponsored by Wyeth Pharmaceuticals France.
To cite this abstract, please use the following information:
Dougados, M., Combe, B., Braun, J., Landewe, R., Sibilia, J., Cantagrel, Alain, et al; Achievement of a Patient Acceptable Symptom State (PASS) and of a Minimum Clinically Important Improvement (MCII) with Etanercept in Refractory Heel Enthesitis Related to Spondyloarthritis: Results of a Double Blind Placebo Controlled Study (HEEL) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1786