Rheumatoid arthritis (RA) is a systemic autoimmune disease characterised by synovial pannus formation leading to cartilage destruction, bone erosion, and disability.
To evaluate the efficiency and safety of adalimumab (ADA) in association with one or more classic remissive drugs in active established RA.
Prospective observational 12 months study in 33 consecutive active RA treated with ADA. Patients were assessed according to a complex protocol including both individual parameters (clinical, biological) and composite disease activity scores (DAS28, CDAI, SDAI), while response to therapy was evaluated based on EULAR and ACR response criteria.
Statistical significant improvement has been demonstrated in all patients under ADA (p < 0.05); after 3 months of treatment 51.5% RA fulfilled ACR20, 39.3% ACR50 and 9% ACR70 criteria; after 6 months of treatment 66.6% of patients and 33.3% fulfilled ACR20 and, respectively, ACR50 criteria. Moreover, 30.3% of all patients had good response after 6 months, 66.6% moderate response and only 3.03% displayed no response in the same period. 24.2% and 45.4% of RA achieved remission (DAS28 < or = 2.6) after 9 and 12 months of ADA, while 39.3% and 21.2% had moderate activity. Rate and type of adverse events demonstrated the safety and good tolerance of ADA.
Our data support the efficacy and safety of ADA in active established RA in the settings of the real-life clinical practice.