Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Rituximab Improved Physical Function and Quality of Life in Patients with Early Rheumatoid Arthritis Who Were Naive to Methotrexate (IMAGE study)

Rigby1,  W., Ferraccioli2,  G., Greenwald3,  M., Zazueta-Montiel4,  B., Fleischmann5,  R., Wassenberg6,  S., Jahreis7,  A.

Dartmouth, Lebanon, NH,
Catholic Univ of the Sacred Heart, Rome, Italy,
Desert Medical Advances, Palm Desert, CA,
Inst, Mexico City, Mexico,
Univ of Texas, Dallas, TX,
Evangelisches Fachkrankenhaus, Ratingen, Germany,
Genentech, South San Francisco, CA,
Roche, Welwyn Garden City, United Kingdom,
Roche, United Kingdom

Purpose:

To assess the effect of rituximab (RTX) with methotrexate (MTX) compared to MTX alone on patient (pt) reported outcomes (PRO) of physical function and health-related quality of life (HRQoL) in pts with early active rheumatoid arthritis (RA) who had not previously been treated with MTX.

Methods:

Inclusion criteria included no prior exposure to MTX, disease duration >=8 weeks and <=4 yrs, swollen and tender joint count >=8; C-reactive protein >=1.0 mg/dL, and positive RF or erosive damage. Pts were randomized to placebo + MTX, RTX (2 × 500mg) + MTX, or RTX (2 × 1000 mg) + MTX. MTX in all groups was initiated at 7.5mg/wk and titrated to 20 mg/wk by Wk 8. RTX was given by IV infusion on Days 1 and 15. At Wk 24, pts with DAS28-ESR>=2.6 received a second RTX course. Those with DAS28-ESR<2.6 were retreated if their DAS28-ESR increased to >=2.6. Physical function was assessed using the Heath Assessment Questionnaire Disability Index (HAQ-DI), and HRQoL with the SF-36, with assessments taken at regular intervals up to 52 wks (primary analysis time point). Minimally clinically important differences (MCID) for HAQ-DI, SF-36 physical component summary (PCS), and mental component summary (MCS) were defined as >=0.22, >5.42, and >6.33 respectively. Additional PRO endpoints included fatigue (FACIT score), patient global score of disease, and pain (determined using 100mm visual analogue scales).

Results:

748 randomized pts received study drug (intent-to-treat population). Pt characteristics were balanced at baseline with mean RA duration of 0.9 yrs and high disease activity (DAS28 >7). At Wk 52, both RTX groups showed significant changes in HAQ-DI (p<0.0001) and also higher proportions of pts achieving MCID compared to MTX alone. Mean change in SF-36 PCS was significant for both dose groups but only RTX (2 × 1000mg) had higher proportions of pts achieving MCID. Change in SF-36 MCS did not achieve significance for either dose group, however higher proportions of pts receiving RTX (2 × 1000mg) achieved the MCID. Fatigue, pain, and pts global disease score were significantly reduced in RTX groups compared to MTX alone.

Table. IMAGE PRO Measures at 52 Weeks

 Placebo + MTXRTX (2 × 500mg) + MTXRTX (2 × 1000mg) + MTX
Mean Change in   
HAQ-DIn=248n=247n=249
 -0.628-0.905***-0.916***
FACITn=244n=239n=245
 6.8309.362*10.282***
PCSn=239n=236n=242
 7.23710.073**10.763***
MCSn=239n=236n=242
 4.8486.1816.662
% Pts with change   
HAQ-DI>=0.2277.4%87.4%*87.6%*
FACIT67.6%72.8%75.1%*
PCS change >5.4263.2%69.9%76.4%**
MCS change >6.3349.0%50.8%57.0%*
*p<0.05,
**p<0.001,
***p<0.0001 compared to MTX alone.

Conclusion:

RTX at either 2 × 500mg or 2 × 1000mg with MTX was associated with significant improvement in physical function and QoL outcomes compared to MTX alone; however, only RTX 2×1000mg had higher proportions of pts achieving the MCID for SF-36 MCS and PCS.

To cite this abstract, please use the following information:
Rigby, W., Ferraccioli, G., Greenwald, M., Zazueta-Montiel, B., Fleischmann, R., Wassenberg, S., et al; Rituximab Improved Physical Function and Quality of Life in Patients with Early Rheumatoid Arthritis Who Were Naive to Methotrexate (IMAGE study) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1665
DOI: 10.1002/art.26739

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