Rituximab for refractory rheumatoid arthritis: a 24-week open-label prospective study.
OBJECTIVE
To study the efficacy of rituximab in active rheumatoid arthritis (RA) patients refractory to disease modifying anti-rheumatic drugs (DMARDs) including the tumor necrosis factor (TNF)-alpha antagonists.


METHODS
Adult patients with active RA despite adequate therapies with conventional DMARDs or anti-TNFalpha agents for at least 3 months were recruited. Inclusion criteria were: (1) Positive RF / anti-CCP; (2) >/= 6 swollen joints and >/= 8 tender joints; (3) ESR >/= 28 mm/hr or CRP >/= 10 mg/L. Eligible patients were given intravenous rituximab infusions at a dose of 1000 mg on days 1 and 15. Assessment was performed 4-weekly thereafter and included tender joint counts (TJC), swollen joint counts (SJC), physician's and patient's global assessment, patient's pain assessment (VAS 0-100 mm), disability index (HAQ-DI), quality of life (SF36), fatigue score (FACIT-F), ESR and CRP. The DAS28, EULAR and ACR responses at week 24 were evaluated.


RESULTS
10 patients (8 women and 2 men) were studied (mean age: 49 years; mean RA duration 7.4 years). Baseline TJC and SJC were 25.1 +/- 13.2 and 12.8 +/- 5.4 respectively. The mean DAS28 score was 7.1 +/- 0.7, and the mean CRP and ESR levels were 52.3 +/- 60 mg/L and 95.8 +/- 32 mm/hr, respectively. The median number of failed DMARDs was 4 and two patients had failed anti-TNFalpha treatment. At week 24, there was a significant drop in TJC, SJC, ESR and CRP. The HAQ-DI score also decreased from 2.1 to 1.7 (p=0.04) while the total SF-36 score improved from 24.8 to 38.3 (p=0.008). Sixty percent of patients achieved EULAR moderate-to-good response. Half of the patients achieved ACR20 and two achieved ACR50 / 70 response. Only one patient experienced a minor infusion reaction.


CONCLUSIONS
Rituximab is effective and well tolerated in patients with refractory RA.
Ho
Ling Yin
LY
Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong SAR, China.
Mok
Chi Chiu
CC
To
Chi Hung
CH
Anselm
Mak
M
Cheung
Mei Yuk
MY
Yu
Ka Lung
KL