Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Bone Mineral Density in Patients with Recent Onset, Active Rheumatoid Arthritis: Two-Year Data of the NEO-RACo Study
Valleala1, Heikki, Kautiainen2, Hannu, Mottonen3, Timo, Hannonen4, Pekka J., Korpela5, Markku, Kaipiainen-Seppanen6, Oili, Paimela7, Leena
Helsinki University Central Hospital, Helsinki, Finland
Medcare Oy, äänekoski, Finland
Turku University Central Hospital, Turku, Finland
Central Hospital, Jyvaskyla
Tampere University Hospital, Tampere, Finland
Kuopio University Hospital, Finland
ORTON hospital, Helsinki, Finland
Oulu University Central Hospital, Oulu, Finland
We have previously reported that the intensive use of FIN-RACo strategy [initial combination of methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine (HCQ) and prednisolone (PRED)] induced strict remission in 53% and sustained remission in 31% of patients with recent onset active rheumatoid arthritis (RA). Radiological progression was rare. Adding Infliximab (INFL) during the first 6 months reflected in higher frequencies of remissions over time and prevented radiological progression during 2 years. Here we report the effect of FIN-RACo strategy on bone mineral density (BMD) in the lumbar spine and the hip in the patients.
In this multicenter (15 centres) trial, we enrolled 100 patients aged <65 y with early (symptoms <=12 mo) active RA. FIN-RACo therapy targeted to remission was started in all patients. The patients were randomized in a double-blind way to receive INFL (3 mg/kg) or placebo (PLA) at weeks 4, 6, 10, 18 and 26. Doses of MTX (max 25 mg/week) and SSZ (max 2 g/day) were individually tailored, doses of HCQ (35 mg/kg/week) and PRED (7.5 mg/day) were constant. Local glucocorticoid injections were allowed. All patients received 1000 mg calcium and 800 IU vitamin D3 daily. BMD was measured by DEXA at entry and at two years.
|Variable||FIN-RACo + PLA, n =31||FIN-RACo + INFL, n=32|
|Age (y)||45.8 ± 10.7||47.1 ± 7.8|
|Symptom duration (mo)||3.8 ± 2.3||4.1 ± 2.7|
|DAS28||5.9 ± 1.2||5.5 ± 1.0|
|Lumbar spine T-score||-0.1 ± 1.6||-0.3 ± 1.2|
|Femoral neck T-score||-0.2 ± 1.0||-0.4 ± 0.8|
Both baseline and 2 year BMD were available for 63 out of 100 patients. Baseline characteristics of these patients are presented above (Mean± SD). At baseline 3 patients in the FIN-RACo + PLA group and none in the FIN-RACo + INFL had T-score below - 2.5. During the 2 years BMD decreased significantly in both treatment groups. A mean (95% CI) change of lumbar spine T-score from 0 to 24 months was -0.2 (-0.4 to -0.1) in the FIN-RACo+PLA and -0.4 (-0.5 to -0.2) in FIN-RACo+INFL. For the femoral neck T-score the mean changes in the 2 groups were -0.2 (-0.3 to -0.1) and -0.2 (-0.7 to - 0.1), respectively. At 2 years, 3 patients in the FIN-RAco + PLA group and 2 in the FIN-RACo + INFL had T-score below -2.5. The BMD loss between the 2 groups was not significantly different.
7.5 mg daily constant PRED led to significant BMD loss despite the marked decline in disease activity. Antiresorptive therapy with bisphosphonates for primary prevention of osteoporosis should be considered when starting long-term PRED >= 7.5 mg, daily in RA.
To cite this abstract, please use the following information:
Valleala, Heikki, Kautiainen, Hannu, Mottonen, Timo, Hannonen, Pekka J., Korpela, Markku, Kaipiainen-Seppanen, Oili, et al; Bone Mineral Density in Patients with Recent Onset, Active Rheumatoid Arthritis: Two-Year Data of the NEO-RACo Study [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1008