Long-term multicenter observational study of Alflutop in Russia: use in elderly patients with osteoarthritis at various sites (report 5)

Osteoarthritis (OA) is one of the most significant medical and social problems due to a steady increase in its incidence and associated disability rates. Objective. To evaluate the efficacy of Alflutop in elderly patients with osteoarthritis (OA) of the knee (KOA) and/or hip (HOA) and/or with low back pain (LBP). Material and methods. This prospective, multicenter, cohort observational study was conducted in 163 clinical centers across 58 cities of the Russian Federation. Of 22,525 enrolled patients with OA at various sites and/or LBP, 10,927 were ≥60 years and comprised the analysis population. Alflutop was prescribed as part of routine care per physician decision or purchased by patients. Study duration was 20–31 days with two visits. Regimens were either 1 mL intramuscularly (IM) for 20 consecutive days or 2 mL IM every other day totaling 10 injections. Efficacy was assessed by time to clinical effect (patient-reported pain reduction), change in pain intensity during movement in the index joint and/or LBP on a visual analogue scale (VAS), health-related quality of life by EQ-5D, and patient global assessment (PGA) on VAS. Treatment adherence, need for nonsteroidal anti-inflammatory drugs, and treatment satisfaction (VAS) were recorded. Results and discussion. Primary efficacy parameters showed pronounced improvement over the treatment course. In patients with KOA (n=6138), median pain reduction (VAS) was 57.1 [33.3; 75] %, median improvement in PGA (VAS) was 40 [14.3; 100] %, and treatment satisfaction was 80 [60; 90] mm. In most patients with HOA (n=4377), substantial improvement was observed: median pain decreased by 50 [33.3; 75] %, PGA increased by 40 [14.3; 100] %, and treatment satisfaction was 80 [60; 90] mm. Among patients with hand OA (n=1346), median VAS improvement was 60 [37.5; 80] %. Marked positive dynamics were recorded for EQ-5D and PGA: from 0.59 [0.52; 0.69] to 0.82 [0.73; 1.0] points (p<0.0001) and from 50 [40; 67] to 80 [70; 90] mm (p<0.0001), respectively. In patients with nonspecific LBP (n=5135), pain decreased and PGA improved: median pain reduction was 57.1 [37.5; 75] % and PGA increased by 50 [14.3; 100] %. A good response (≥50% pain reduction) was observed in 65.1% of cases. Conclusion. This observational study supports the symptomatic effect of Alflutop and its appropriateness for use in patients aged ≥60 years with OA of various sites and with LBP.