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One-year follow-up of ankylosing spondylitis patients responding to rituximab treatment and re-treated in case of a flare
  1. In-Ho Song1,
  2. Frank Heldmann2,
  3. Martin Rudwaleit1,3,
  4. Joachim Listing4,
  5. Heiner Appel1,
  6. Iris Haug-Rost5,
  7. Jürgen Braun2,
  8. Joachim Sieper1
  1. 1Department of Medical Clinic I/Rheumatology, Charité Medical University, Campus Benjamin Franklin, Berlin, Germany
  2. 2Department of Rheumatology, Centre of Rheumatology, Herne, Germany
  3. 3Endokrinologikum, Berlin, Germany
  4. 4Department of Statistics, German Rheumatism Research Center, Berlin, Germany
  5. 5Department of Rheumatology, Specialty Care/Medical Affairs Roche Pharma AG, Grenzach-Wyhlen, Germany
  1. Correspondence to Professor Joachim Sieper, Department of Medical Clinical I/Rheumatology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin 12200, Germany; joachim.sieper{at}

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Recently we reported on a good clinical response at week 24, especially in tumour necrosis factor (TNF)-blocker-naive patients with ankylosing spondylitis (AS) who were treated with a first course of rituximab (two infusions of each 1000 mg of rituximab with 100 mg methylprednisolone at baseline and week 2).1

Here we report on the follow-up of these patients with a special focus on the good responders.

At week 24, patients regarded as responders were offered to be followed up and to receive a second course of rituximab in case of flare. A response was defined as reaching 20% improvement in disease activity according to the Assessment of SpondyloArthritis international Society criteria (ASAS20)2 compared with screening on at least two consecutive visits (out of four visits: week 12, week 16, week 20 and week 24). Flare was defined as a 1.5-point worsening of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) compared to the lowest BASDAI between week 12 and week 24. Flare patients were then followed for another 48 weeks (between the flare visit (=R-baseline) and R-week …

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  • Contributors I-HS: study design, project management, patient recruitment, data analysis, data interpretation, manuscript preparation. FH: patient recruitment. MR: study design, data interpretation. JL: statistical analysis. HA and JB: data interpretation. IH-R: project management. JS: study design, principal investigator, sponsor, data interpretation, manuscript preparation.

  • Funding This study was supported by an unrestricted grant from Roche.

  • Competing interests This study was supported by an unrestricted grant from Roche. IS and FH: Wyeth Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals: consulting fees or other remuneration. IR: employee from Roche Pharma AG. MR, JB and JS: Wyeth Pharmaceuticals, Merck Sharp Dohme/Schering Plough, Abbott Immunology Pharmaceuticals, UCB: consulting fees or other remuneration. HA and JL: none.

  • Patient consent Obtained.

  • Ethics approval Ethics approval provided by 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.

  • Data sharing statement We collected blood for cytokine analysis.