Rheumatoid arthritis (RA) is a systemic autoimmune disease characterised by synovial pannus formation leading to cartilage destruction, bone erosion, and disability.
Aim: To evaluate the efficiency and safety of adalimumab (ADA) in association with one or more classic remissive drugs in active established RA.
Material and methods: 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.
Results: 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.
Conclusions: Our data support the efficacy and safety of ADA in active established RA in the settings of the real-life clinical practice.