Adalimumab therapy in patients with active rheumatoid arthritis.

Aim: To evaluate efficacy and safety of adalimumab (ADA), a monoclonal anti-TNFalpha antibody, in rheumatoid arthritis (RA).

Material And Method: 5 years retrospective observational study on 70 active RA (ARA 1987 modified criteria; 48 women; mean age 52.6 +/- 11.7 years; mean disease duration 6.7 +/- 3.2 years, mean DAS28 6.5 +/- 1.3) treated with ADA (classic regimen). All patients have been assessed according to a standard protocol: (i) clinical (tender and swollen joints; pain; global disease evaluation), (ii) inflammatory and (iii) immune parameters (total antinuclear and anti-double stranded DNA antibodies), (iv) activity and functional scores, (v) response to therapy (EULAR), (vi) adverse events. Evaluation was performed at baseline and every 3 months. Statistical analysis was done in SPSS-13, p < 0.05.

Results: Statistical significant improve in RA activity (mean final DAS28 3.6 +/- 0.8, p < 0.05), functional scores (mean HAQ 1.3 +/- 0.3, p < 0.05) and decreased X-ray progression (Sharp score) have been reported; 60% RA were responders (mean EULAR 2.7 +/- 1.2), 35.7% in remission, while switching to another biological agent (14.28% ADA failure) was done in 20% cases, clinical, biological and radiological efficacy and favorable safety profile of ADA have been demonstrated in real life long-term administration in active RA.