Background/Objectives: Intra-articular polynucleotide (PN) has emerged as an alternative to hyaluronic acid (HA) for treating knee osteoarthritis (OA), with randomized controlled trials (RCTs) reporting similar or greater pain reduction. Real-world evidence on both single- and repeated-cycle outcomes remains limited. This study evaluated PN's real-world effectiveness and safety and whether its pain reduction falls within ranges reported in previous PN-HA RCTs, and evaluated repeated-cycle outcomes. Methods: Clinical data from 1048 PN-treated OA patients were retrospectively reviewed. The safety set comprised 1024 patients with follow-up visits. The efficacy set included 975 patients who completed 3-5 weekly PN injections with evaluable VAS, CGI, and PGI data at baseline, 3, and 6 months. A repeated-treatment subgroup (n = 45) received a second PN cycle 6 months later. First-cycle outcomes were compared with PN-HA RCTs. Results: In the first-cycle (n = 975), VAS decreased from 50.30 mm to 23.02 and 22.43 mm at 3 and 6 months (-27.28 and -27.87 mm; p n = 45), despite a lower second-cycle baseline VAS of 31.00 mm (vs. 50.30 mm at first-cycle baseline), VAS decreased to 14.07 mm and 17.33 mm at 3 and 6 months (-16.93 and -13.67 mm; p Conclusions: PN provided meaningful 6-month pain reduction in a comparable magnitude to previous RCTs and showed consistent benefit with repeated administration without new safety concerns.
Kim et al. (Tue,) studied this question.