Objectives To assess the long-term clinical efficacy of etanercept (ETN) in patients with early axial spondyloarthritis (including both non-radiographic axial SpA – nr-axSpA and radiographic axial SpA – ankylosing spondylitis, AS) with a symptom duration of <5 years who participated in the long-tem (until year 6) extension of the ESTHER trial .
Methods In the previously reported core phase ESTHER trial axial SpA patients were treated with ETN (n=40) versus sulfasalazine (n=36) during 48 weeks . After one year all patients were treated continuously with ETN (a few (n=12) patients temporarily interrupted treatment in the 2nd year to assess time to flare and were then (re-)treated with ETN) . Clinical efficacy data were analysed for patients who completed six years of treatment.
Results Out of 76 patients who entered the study at baseline, 44.7% (n=34, 17 with nr-axSpA and 17 with AS) completed year 6 of the study. In both subgroups a constantly and similarly good clinical response was observed until year 6 with more than a half of the patients in both groups reaching an ASAS partial remission response at year 6 (table). Similarly high and comparable between groups were ASAS40 response and a 50% improvement of BASDAI as compared to baseline. Mean BASDAI and BASFI values were constantly <2 at years 4, 5 and 6 in both groups (table).
Conclusions There was a sustained and similar clinical response in patients with nr-axSpA and AS treated with ETN over 6 years. Similar clinical response indicates that the presence or absence of radiographic sacroiliitis at baseline does not determine clinical response to anti tumour necrosis factor therapy over time that supports the concept of axial SpA as one disease.
Song IH, et al. Ann Rheum Dis 2011;70:590-6.
Song IH, et al. Ann Rheum Dis 2012;71:1212-5.
Acknowledgements The study was supported by an unrestricted research grant von Pfizer.
Disclosure of Interest D. Poddubnyy Consultant for: Abbvie, MSD, Pfizer, UCB, I.-H. Song Employee of: Abbvie, K.-G. Hermann Speakers bureau: Abbvie, MSD, Pfizer, UCB, H. Haibel: None declared, J. Callhoff: None declared, J. Listing: None declared, B. Buss: None declared, B. Freundlich: None declared, E. Lange Employee of: Pfizer, M. Rudwaleit Consultant for: Abbvie, MSD, Pfizer, UCB, J. Sieper Grant/research support from: Abbvie, MSD, Pfizer, Consultant for: Abbvie, MSD, Pfizer, UCB