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Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study
  1. I-H Song1,
  2. F Heldmann2,
  3. M Rudwaleit1,
  4. H Haibel1,
  5. A Weiß3,
  6. J Braun2,
  7. J Sieper1
  1. 1Department of Rheumatology, Charité Medical University, Campus Benjamin Franklin, Berlin, Germany
  2. 2Centre of Rheumatology, Herne, Germany
  3. 3German Rheumatism Research Center, Berlin, Germany
  1. Correspondence to Joachim Sieper, Charité, Campus Benjamin Franklin, Medical Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany; joachim.sieper{at}charite.de

Objective To prospectively explore the short-term efficacy and safety of abatacept in patients with ankylosing spondylitis (AS).

Methods In this prospective open-label pilot study, abatacept (10 mg/kg) was administered intravenously on days 1, 15, 29 and every 28 days thereafter up to week 24 in 15 tumour necrosis factor α (TNFα)-inhibitor naive patients (group 1) and 15 patients with inadequate response to TNFα inhibitors (group 2) with active AS. The primary end point was the proportion of patients with 40% improvement according to the Assessment of SpondyloArthritis international Society criteria (ASAS40) in both groups at week 24.

Results At week 24, ASAS40 was reached by 13% of group 1 and 0% of group 2; 20% improvement (ASAS20) was reached by 27% and 20%, respectively. There was no significant change of Bath Ankylosing Spondylitis Disease Activity Index score, patient global assessment or C reactive protein. Overall, abatacept was well tolerated.

Conclusions In this pilot open-label AS study a major response was not observed.

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Objective To prospectively explore the short-term efficacy and safety of abatacept in patients with ankylosing spondylitis (AS).

Methods In this prospective open-label pilot study, abatacept (10 mg/kg) was administered intravenously on days 1, 15, 29 and every 28 days thereafter up to week 24 in 15 tumour necrosis factor α (TNFα)-inhibitor naive patients (group 1) and 15 patients with inadequate response to TNFα inhibitors (group 2) with active AS. The primary end point was the proportion of patients with 40% improvement according to the Assessment of SpondyloArthritis international Society criteria (ASAS40) in both groups at week 24.

Results At week 24, ASAS40 was reached by 13% of group 1 and 0% of group 2; 20% improvement (ASAS20) was reached by 27% and 20%, respectively. There was no significant change of Bath Ankylosing Spondylitis Disease Activity Index score, patient global assessment or C reactive protein. Overall, abatacept was well tolerated.

Conclusions In this pilot open-label AS study a major response was not observed.

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Footnotes

  • Funding This study was supported by an unrestricted grant from Bristol-Myers Squibb.

  • Competing interests I-HS and HH: consulting fees or other remuneration from Wyeth/Pfizer Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals. FH: consulting fees or other remuneration from Merck Sharp Dohme/Schering Plough. MR, JB and JS: Wyeth/Pfizer, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals, UCB. AW: none.

  • Ethics approval Approval was obtained from the local ethics committee (Landesamt für Gesundheit und Soziales, Geschäftsstelle der Ethik-Kommission des Landes Berlin, Sächsische Straße 28, 10707 Berlin, Germany).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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