Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


Tocilizumab Monotherapy Improves BONE Mineral Density AS Well AS TNF Blockers PLUS Methotrexate with Methotrexate-RESISTANT Activerheumatoid Arthritis. AN OPEN-Label RANDOMIZED CLINICAL TRIAL. T-BONE TRIAL.

Kume1,  Kensuke, Amano1,  Kanzo, Yamada1,  Susumu, Hatta2,  Kazuhiko

Hiroshima Clinic, Hiroshima, Japan
Hatta Clinic, Kure, Japan

Background/Purpose:

To compare the effects of tocilizumab (TCZ) monotherapy, and infliximab (IFX) plus methotrexate(MTX), and adalimumab(ADA) plus MTX, respectively on bone mineral density (BMD) in patients with rheumatoid arthritis (RA; without osteoporosis) patients despite MTX treatment, in a prospective open-label randomized controlled design.

Methods:

42 RA patients with moderate to severe active disease (DAS28 > 3.2) despite MTX treatment were randomly assigned to receive TCZ (8mg/kg per 4 weeks) alone (n=14), IFX (3–10mg/kg per 8 weeks) plus MTX (n=14), or ADA (40mg per 2 weeks) plus MTX (n=14). All patients have no previous history of lumbar and hip fractures. Patients receiving or having received bisphosphonates or hormone replacement therapy, steroids, or any biologics were excluded. The dosage of all disease modifying anti-rheumatic drugs had been stable for at least 8 weeks prior to enrollment. The primary outcomes were changes in lumbar and femoral BMD by dual-energy X-ray absorptiometry, secondary outcome were serum osteocalcin and serum crosslaps from baseline to12 months. Clinical data were collected at regular visit. All patients were taking calcium (1 g/day) and vitamin D (800 IU/day).

Results:

The characteristics of each group at baseline were not significantly different. In all groups there was significant increase from baseline to 12 months in BMD in the spine (month12-baselineTCZ: BMD 0.04±0.002 g/cm2, p < 0.001; T-score, p < 0.001; Z-score, p < 0.01; IFX: BMD 0.03±0.004 g/cm2, p < 0.001; T-score, p < 0.001; Z-score, p < 0.01; ADA: BMD 0.03±0.003 g/cm2, p < 0.001; T-score, P < 0.001; Z-score, p < 0.01) and the femoral neck (TCZ: BMD 0.03±0.002 g/cm2, p < 0.001; T-score, p < 0.001; Z-score, p < 0.01; IFX: BMD 0.03±0.006 g/cm2, p < 0.001; T-score, p < 0.001; Z-score, p < 0.01; ADA: BMD 0.02±0.008g/cm2, p < 0.001; T-score, p < 0.001; Z-score, p < 0.01). The change (month12-baseline) BMD were no significant differences between each group in BMD in spine or in femoral neck. In all groups there was significant increase from baseline to 12 months in osteocalcin serum levels (month 12-baseline, TCZ:7.2±0.65 ng/ml, p<0.01; IFX: 6.2±0.85 ng/ml, p<0.01;ADA: 6.8±0.76 ng/ml p<0.01) and significant decrease in crosslaps serum levels (month 12-baseline, TCZ: -3.2±0.28 ng/ml, p<0.01;IFX: -2.9±0.45 ng/ml, p<0.01; ADA: -2.5±0.66 ng/ml p<0.01) but no change in serum calcium was observed. There were no significant differences between each group in osteocalcin serum levels or in crosslaps serum levels. However, the changes in markers of bone metabolism and BMD were not correlated in all groups. HAQ score, DAS28-ESR score, and CRP improved significantly in all groups from baseline to 12 months (p<0.05). They were no significant difference between groups.

Conclusion:

The data support the hypothesis that TCZ monotherapy may exert beneficial effects on bone metabolism in active RA patients despite MTX to the same extent as IFX or ADA plus MTX. We need further studies to compare the effects of TCZ alone, and TCZ plus MTX on BMD in patients with RA patients despite MTX treatment.

To cite this abstract, please use the following information:
Kume, Kensuke, Amano, Kanzo, Yamada, Susumu, Hatta, Kazuhiko; Tocilizumab Monotherapy Improves BONE Mineral Density AS Well AS TNF Blockers PLUS Methotrexate with Methotrexate-RESISTANT Activerheumatoid Arthritis. AN OPEN-Label RANDOMIZED CLINICAL TRIAL. T-BONE TRIAL. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :396
DOI:

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