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Comparison of alfacalcidol or prednisone effects as an add-on treatment to methotrexate in active rheumatoid arthritis

Katarina Simic Pasalic, Tatjana Zivanovic Radnic, Mirjana Sefik Bukilica, Nemanja Damjanov, Andjela Gavrilovic & Jelena Vojinovic

Objectives: To compare efficacy of alfacalcidol (1αD3) or prednisone as an add-on treatment for patients with active Rheumatoid Arthritis (RA). Methods: Sixty-seven RA patients on maximum tolerated stable methotrexate (MTX) dose, yet with moderate/high RA activity were included. Written consent, demographic data and blood samples for inflammatory biomarkers, calcium and lipid metabolism, cytokine testing were obtained, and disease activity was calculated (DAS28). They were randomly assigned to either three-month treatment with 1 μg (group A1), 2 μg (group A2), 3 μg (group A3) 1αD3 daily or prednisone (group C) 20 mg daily, for the first month and 10 mg afterwards, in addition to MTX. At the end of each treatment period, disease activity and laboratory tests were reassessed. Results: Out of 67 patients, 68% females, average age 56.24 ± 12.423, disease duration 7.71 ± 6.68 years, MTX dose 15.41 ± 3.28 mg/week, average RA activity DAS28 5.58 ± 0.905. Patients randomized to four different study treatments were fully comparable. After three-month treatment, we found highly significantly reduced disease activity in all groups as per DAS28 and patient visual assessment scale - PVAS (p<0.01). Group A2 and C in term of ΔDAS28 and ΔPVAS (p˂0.05) did not differ. In 1αD3 2 μg (A2) treated patients (N=19), C-Reactive Protein (CRP) (p˂0.01), erythrocyte sedimentation rate (ESR) and interleukin-6 (IL6) levels (p˂0.05) were significantly reduced, while High-Density Lipoprotein (HDL) increased (p˂0.05). Serum calcidiol in prednisone users (N=16) significantly decreased (p˂0.01). Conclusion: Addition of either 1 μg, 2 μg, 3 μg 1αD3 or prednisone to MTX for three months, led to a significant reduction of disease activity in active RAy.