Assessment of the safety, tolerability and effectiveness of first Russian generic aceclofenac in patients with undifferentiated peripheral inflammatory arthritis

Aim. To evaluate the effectiveness and tolerability of the drug in patients with undifferentiated peripheral inflammatory arthritis (UPIA).

Materials and methods. We observed 60 patients (39 women and 21 men) met G. Hazlewood et al., UPIA criteria, 2011. Patients were divided into 3 groups: with monoarthritis, oligoarthritis and polyarthritis. They took aceclofenac 100 mg twice day for 3 weeks.

Results. We noted significant decreasing in pain level according to visual analogue scale: in patients with monoarthritis – by 69.3 mm (p<0.001); in oligoarthritis group – by 47.5 mm (p<0.001), in patients with polyarthritis – by 30 mm (p<0.001). The life quality by the EQ-5D-5L index was improved too in all groups from 0.616 to 0.829 (p<0.001). The satisfaction with the therapy was: in monoarthritis patients (80% of patients and 93% of doctors noted good results), in oligoarthritis group (53% and 39% accordingly) and polyarthritis (74% and 64% respectively). We suppose the difference was due to the fact that mono- and oligoarthritis patients suffered from initial forms of seronegative spondylarthropathy, in which the effectiveness of NSAIDs is traditionally higher; polyarthritis patients probably had debut of rheumatoid arthritis. Adverse events of therapy were mild. We noted gastrointestinal tract symptoms (dyspepsia) and increased ALT in 10 patients and increased blood pressure – in 1 patient. The symptoms did not require discontinuation of therapy.

Сonclusion. Post-registration observational study of first Russian generic aceclofenac (“Alental”, Vertex, Russia) was conducted. In UPIA patients aceclofenac therapy was most effective in mono- and oligoarthritis patients. The first Russian generic aceclofenac (“Alental”, Vertex, Russia) has good efficacy, tolerability and safety and can be recommended for arthritis treatment.