Table 1

Efficacy parameters in (A) the group of patients who received a second course of rituximab and (B) the group of patients who were followed until week 48 without further re-treatment

GroupParameters/study visitScreeningLowest value between W12–W24W48R-baseline (flare visit)R-W24R-W48
Group A: five patients who flared and received a second course of rituximabBASDAI (0–10)5.7 (1.9)1.6 (1.6)NA4.2 (1.6)3.1 (1.3)1.7 (1.5)
CRP (0.6 mg/dl)1.8 (1.5)1.0 (1.0)NA1.2 (1.3)1.3 (1.2)0.4 (0.1)
ASDAS3.8 (1.0)1.9 (1.0)NA2.9 (1.0)2.4 (0.5)1.3 (0.2)
Patient global (0–10)7.0 (2.4)1.6 (1.5)NA4.6 (0.9)3.0 (1.0)2.0 (2.0)
Swollen joint count (0–64)0.2 (0.5)0.1 (0.4)NA0.8 (1.8)1.0 (2.2)0.0 (0.0)
Enthesitis score (0–13)3.2 (6.1)0.4 (0.9)NA1.8 (3.5)0.4 (0.9)0.8 (1.5)
CD19 (cells/μl)249.8 (118.7)9.2 (10.4)NA56.3 (46.1)7.3 (5.3)64.8 (74.3)
BASDAI50NA20%NANA20%50%*
ASAS40NA40%NANA20%50%*
ASAS partial remissionNA20%NANA20%50%*
GroupParameters/study visitScreeningW24W48R-baseline (flare visit)R-W24R-W48
Group B: four patients who did not flare and were followed without further treatmentBASDAI (0–10)6.1 (1.2)3.0 (1.6)2.7 (1.7)NANANA
CRP (0.6 mg/dl)1.7 (1.8)1.1 (1.0)0.9 (0.8)NANANA
ASDAS3.7 (0.8)2.3 (0.6)1.9 (0.5)NANANA
Patient global (0–10)7.5 (1.7)3.3 (1.9)3.0 (1.4)NANANA
Swollen joint count (0–64)0.0 (0.0)0.0 (0.0)0.0 (0.0)NANANA
Enthesitis score (0–13)2.0 (4.0)2.8 (5.5)2.3 (4.5)NANANA
CD19 (cells/μl)267.6 (88.7)7.2 (7.8)56.4 (69.1)NANANA
BASDAI50NA75%50%†NANANA
ASAS40NA75%50%†NANANA
ASAS partial remissionNA50%25%†NANANA
  • Values given as mean values (SD) unless otherwise stated.

  • *R-W48 reached by four patients; BASDAI50, ASAS40 and ASAS partial remission only reached TNF-naive patients.

  • †Week 48: BASDAI50, ASAS40 and ASAS partial remission was only reached by TNF-naive patients.

  • ASAS, response criteria according to the Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CD19, cluster of differentiation (B cell count); CRP, C reactive protein; NA, not applicable; R, re-treatment (refers to those visits after a second course of rituximab); R-baseline, baseline equals the flare visit; TNF, tumour necrosis factor; W, week.