Multicenter Longitudinal Observational Study Pharmaceuticals Alflutop in Russia (message 2)

Abstract

Osteoarthritis (OA) is one of the most important medical and social problems due to the steady increase in morbidity and disability. Prevention, management of risk factors, and early treatment of OA are critical.Objective of the ISKRA study was to evaluate the efficacy of Alflutop in patients with OA of different locations and/or low back pain (LBP) with or without concomitant diseases.Material and methods. We selected 11,136 patients with OA of specific localizations aged 50 to 72 years. The duration of the study ranged from 20 to 31 days, and the number of visits was 2 (B1 and B2). Alflutop was prescribed 1 ml intramuscularly (IM) daily No. 20 or 2 ml IM every other day No. 10.The efficacy of therapy was determined by the time of onset of clinical effect (pain reduction, as assessed by the patient), the dynamics of pain intensity in the studied joint during movement and/or LBP according to the visual analogue scale (VAS), the assessment of quality of life according to the EQ-5D questionnaire and the patient's general health status (PGH) according to VAS. We assessed treatment adherence, need for nonsteroidal anti-inflammatory drugs (NSAIDs), satisfaction with treatment (based on VAS). The presence of comorbidities was also considered.Results and discussion. In hand OA (n=2776), a positive effect of therapy was observed in 98.6% of cases, according to patients' assessment. During the course of therapy, there was a significant decrease in pain on movement in the hands (according to VAS), improvement in PGH and quality of life (according to EQ-5D). Rapid development of the analgesic effect was seen on average at day 9.In hip OA (n=6666), a decrease in pain was noted in 83.3% of cases (<40 mm), improvement in PGH and quality of life in most patients, and a decrease in the need for NSAIDs in 64.9%.In the generalized form of OA (n=1694), significant clinical improvement was achieved in 97.1% of patients. A pain reduction ≥50% from baseline was noted in nearly 65% of cases.Elderly age, more severe radiographic manifestations of OA, low quality of life and compliance, and concomitant diseases were associated with a lower effect of therapy in hand and hip OA. In hand OA, high pain scores and worse PGH VAS scores also played a role. In hip OA, lower success was observed more often in women, and in hand OA — in men.In the generalized form of OA, lower satisfaction with pain management was associated with age, female sex, high body mass index, long history of OA, advanced radiographic stages, poorer quality of life and compliance, and comorbidity.Conclusion. The results of the use of Alflutop in hand and hip OA and generalized form of OA suggest the usefulness of its wide application in real clinical practice. Consideration and correction of the factors associated with less pronounced analgesic effect of the drug will improve the effectiveness of OA therapy.