Rituximab for Refractory Rheumatoid Arthritis: A 24-Week Open-Label Prospective Study

Ling Yin Ho, Chi Chiu Mok*, Chi Hung To, Anselm Mak, Mei Yuk Cheung, Ka Lung Yu
Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong SAR, China

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2007 Bentham Science Publishers Ltd.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestrictive use, distribution, and reproduction in any medium, provided the original work is properly cited.

* Address correspondence to this author at the Department of Medicine, Tuen Mun Hospital, Tsing Chung Koon Road, New Territories, Hong Kong, SAR China; Tel: (852) 2468 5386; Fax: (852) 2456 9100; E-mail:



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)-α antagonists.


Adult patients with active RA despite adequate therapies with conventional DMARDs or anti-TNFα 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.


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-TNFα 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.


Rituximab is effective and well tolerated in patients with refractory RA.

Keywords: Biologics, rituximab, anti-TNFα, refractory, treatment..