001 Weight 0 003 0 002 to 0 004 <0 001 Baseline DAS28 0 013 0 000

001 Weight 0.003 0.002 to 0.004 <0.001 Baseline DAS28 0.013 0.000 to 0.025 0.05 AUC DAS28 −0.021 −0.035 to −0.007 <0.01 Age × treatment with prednisone 0.002 check details 0.000 to 0.004 0.04 This mixed model includes 167 patients (71 % of the trial population) with 429 sBMD measurements. Fixed effects, except for the beta’s of the different study centers, are described in the table. Study center, female gender, higher age, lower weight, higher DAS28 during the trial, and treatment with placebo at lower age were significantly related with lower sBMD values at

the left hip sBMD standardized bone mineral BI 2536 density, CI confidence interval, DAS28 disease activity score based on 28 joints, AUC area under the curve Furthermore, disease severity was of influence, reflected by the negative influence on sBMD of higher DAS28 (included in the model as area under the curve of all DAS28 measurements during the complete trial period) for the lumbar spine and hip. A rheumatoid factor positive status did negatively influence the sBMD at the lumbar spine, but not at the hip. If the model

for lumbar sBMD was created without the variable “rheumatoid factor,” the model included 170 instead of 145 patients (72 % instead of 61 % of the original trial population). In that case, age and weight were still significantly associated with lumbar sBMD values, but the influence of DAS28 during the trial was just not significant anymore. If the mixed models were created with baseline SHS and progression of SHS during the trial instead of DAS28 measurements, EX 527 in vivo a significant influence of progression of SHS was found (beta −0.007, 95 % CI of beta −0.014 to −0.001, p = 0.03) at the lumbar spine, but not at the hip. Anti-TNF alpha treatment During the Interleukin-2 receptor trial, in 58 patients, adalimumab was added to the strategy during the trial as protocolized strategy step because of insufficient response to treatment

with methotrexate and prednisone or placebo. DXA scans at 0, 1, and 2 years were performed in respectively 76, 84 and 71 % of these patients. Of the patients who needed adalimumab, only 16 (28 %) had been treated with prednisone. Patients who needed adalimumab co-therapy had a significantly lower baseline sBMD at the hip (mean 0.89 ± 0.14 SD versus mean 0.94 ± 0.15 SD, p = 0.04) but not at the lumbar spine. When we included the number of adalimumab injections into the models, we found a positive impact of the number of adalimumab injections on sBMD in the lumbar spine (beta 0.003, 95 % CI of beta 0.000 to 0.006, p = 0.03), while the influences of other variables stayed unchanged. At the hip, the number of adalimumab injections was associated with a decrease in sBMD (beta −0.003, 95 % CI of beta −0.004 to −0.001, p < 0.01), while the influence of gender was not significant anymore.

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