Original paper
The safety and efficacy of adalimumab for the treatment of ankylosing spondylitis (AS) and active psoriatic arthritis (PsA) in patients in a 16-week study

Objective:To demonstrate the safety and efficacy of adalimumab for the treatment of active psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in patients with an inadequate response to disease-modifying anti-rheumatic drugs (DMARD) and non-steroidal anti-inflammatory drugs (NSAIDs).
Material and methods:Nine patients with PsA and 7 patients with AS receiving subcutaneous injections of adalimumab 40 mg every other week were prospectively studied over a period of 16 weeks. Clinical evaluations for some parameters of disease activity of PsA and AS such as tender and swollen joints, morning stiffness, quality of life (HAQ), ESR and CRP were performed before the study and at each visit. The occurrence of adverse reactions was noted.
Results:Thirteen patients (81%) completed 16 weeks of study. Treatment termination was due to adverse events and inefficacy in 2 and poor compliance in one patient. Significant improvements in BASDAI, ASAS20 and ASAS50 response at week 6 and 16 were demonstrated. At week 16, an ACR20 response was achieved by 55%, ACR50 by 22%, and ACR70 by 33% of patients with PsA. Altogether adverse events were reported in 6 patients (37%) but only 2 (18%) of the patients discontinued adalimumab permanently. Conclusions: In this study of patients who had active PsA or AS and a previous, inadequate response to NSAID or DMARD therapy, adalimumab was well tolerated and significantly reduced the symptoms of active PsA and AS during 16 weeks of therapy.