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THU0141 (2018)
Long-term effects on bone mineral density after four years of treatment with two intensive combination strategies, including initially high dose prednisolone, in early rheumatoid arthritispatients: the cobra-light trial
M.J. Lucassen1,2, M.M. ter Wee1,2, D. den Uyl1, N.P. Konijn1, M.T. Nurmohamed1,3, D. van Schaardenburg3,4, P.J. Kerstens3,5, I.E. Bultink1, L.H. Van Tuyl1, M. Boers1,2, W.F. Lems1,3
1Rheumatology
2Epidemiology and Biostatistics, VU University Medical Center
3Rheumatology, Research Institute Reade
4Rheumatology, Amsterdam Medical Center, Amsterdam
5Rheumatology, Westfriesgasthuis, Hoorn, Netherlands

 

Background: COmbinatie therapie Bij Reumatoide Artiritis (COBRA)-light therapy (methotrexate and initially 30 mg/day prednisolone) has proven to be non-inferior to COBRA therapy (methotrexate, sulfasalazine and initially 60 mg/day prednisolone) in the first year of treatment of early rheumatoid arthritis (RA) patients.

Objectives: This study assessed changes in bone mineral density (BMD) after four years in early RA patients initially randomised to one year of COBRA or COBRA-light therapy.

Methods: In the open-label, randomised, non-inferiority trial patients were assigned to COBRA or COBRA-light therapy. After one year, treatment was at the discretion of the treating rheumatologists. BMD in g/cm2 was measured at baseline, after one, two and four years at total hip, femoral neck, and lumbar spine with dual-energy X-ray absorptiometry (DXA).

Results: Of the 164 original patients, 154 could be assessed after a follow-up of four years (range 34 to 74 months); 68% were female; mean (SD) age at follow-up 5213 years. In the COBRA-light group, 11% of the patients used bisphosphonates after four years; the mean cumulative prednisolone dosage was 2.6 g (inner quartiles:1.9; 5.9) and 49% of the patients had minimal disease activity (DAS44 <1.6). In the COBRA group, these numbers were 10%, 3.2 g (2.5; 6.2) and 49%, respectively. At the lumbar spine, both groups showed no significant decline in BMD over four years and no difference between treatment groups in BMD change (table 1). At the hips, 1.7% to 3.7% BMD loss over four years was found with slightly but significantly more loss in the COBRA-light group (table 1).

Outcomes are mean (SD) unless stated otherwise. BMD in g/cm2.+Significant difference between COBRA-light and COBRA on average over time. *Adjusted for bisphosphonate usage (yes vs no). **Adjusted for bisphosphonate usage (yes vs no), cumulative prednisolone usage, age, gender and disease activity based on DAS44 (DAS44 <1.6 in remission vs DAS44 ≥1.6 not). CI, confidence interval; GEE, Generalised Estimating Equations; T4, measurement after four years; SD, Standard Deviation.

Conclusions: In modern treat-to-target management of RA, including bone surveillance, a high starting dose of prednisolone, either 30 or 60 mg/day, was not associated with a dramatically increased bone loss at the lumbar spine, and minor losses at the hip over four years.

Disclosure of Interest: M. Lucassen: None declared, M. ter Wee: None declared, D. den Uyl: None declared, N. Konijn: None declared, M. Nurmohamed Speakers bureau: Janssen, Roche, MSD, Pfizer, Eli Lilly, BMS and Abbvie, D. van Schaardenburg: None declared, P. Kerstens: None declared, I. Bultink Speakers bureau: Lilly Netherlands, MSD, Amgen BV, UCB Pharma BV, Sanofi Genzyme BV, L. Van Tuyl: None declared, M. Boers Consultant for: Pfizer, Union Chimique Belge and Teva, W. Lems Grant/research support from: Pfizer, Speakers bureau: Pfizer, Abbvie and Roche

DOI: 10.1136/annrheumdis-2018-eular.2826

Abstract THU0141 – Table 1 BMD values and changes in BMD during four years of treatment

COBRA-Light

COBRA

GEE analyses

Baseline

Bone Loss

Baseline

Bone Loss

Mean difference

CI

P

Absolute

% of baseline

Absolute

% of baseline

Lumbar Spine

1.10 (0.15)

−0.01 (0.08)

−0.5

1.12 (0.18)

−0.01 (0.08)

−1.0

−0.01

−0.03–0.02

0.56

−0.01*

−0.03–0.02

0.56

−0.01**

−0.03–0.02

0.59

Total Hip

0.96 (0.13)

−0.03 (0.05)

−3.3

0.95 (0.15)

−0.02 (0.05)

−1.7

−0.01

−0.02–0.00

0.05+

−0.01*

−0.02–0.00

0.05+

−0.01**

−0.03–0.00

0.02+

Femoral Neck

0.88 (0.12)

−0.03 (0.05)

−3.7

0.90 (0.16)

−0.03 (0.06)

−3.0

−0.01

−0.04–0.02

0.38

−0.01*

−0.04–0.01

0.37

−0.01**

−0.04–0.01

0.29



Citation: Ann Rheum Dis, volume 77, supplement Suppl, year 2018, page A290
Session: Rheumatoid arthritis – comorbidity and clinical aspects