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Objective There are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data. Methods This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0–100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs). Results 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (− 17.7 points (95% CI − 23.1; − 12.4); p  < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI − 17.0; − 4.9), physical function (18.0 points; 95% CI − 19.1; − 10.6), and PGA (16.3 points; 95% CI − 23.1; − 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related. Conclusion This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection. Trial registration: Clinicaltrials.gov NCT04179552.

Background Knee osteoarthritis is a highly prevalent and painful joint disorder with limited long-term treatment options. Intra-articular corticosteroids and hyaluronic acid offer only short-term relief and may have safety concerns. This study aimed to evaluate the long-term effectiveness and safety of a single intra-articular injection of 2.5% polyacrylamide hydrogel in individuals with moderate to severe knee osteoarthritis. Methods This prospective, multicentre, open-label, single-arm clinical study enrolled 49 participants who received a single 6 mL intra-articular injection of 2.5% polyacrylamide hydrogel. After 1 year, 35 participants entered an extension study with yearly assessments up to 5 years post treatment. The primary outcomes for the extension phase included changes from baseline in WOMAC subscales (pain, stiffness, physical function) and Patient Global Assessment (PGA). Safety was evaluated through the incidence of adverse events. Statistical analyses included a mixed model for repeated measures and sensitivity analyses using ANCOVA and baseline observation carried forward. Results Of the 49 participants, 27 completed the five-year follow-up. Statistically significant improvements from baseline were observed in WOMAC pain (−14.6; 95% CI: −21.4 to −7.7; p  = 0.0002), stiffness (−19.6; 95% CI: −29.9 to −9.3; p  = 0.0006), physical function (−12.5; 95% CI: −19.8 to −5.2; p  = 0.0015), and PGA (−13.4; 95% CI: −23.3 to −3.5; p  = 0.0100). These improvements were sustained throughout the five-year period. A total of 47 adverse events were reported in the extension study, with no serious events attributed to the investigational device. No new adverse device effects were reported in the extension study. Conclusions A single intra-articular injection of 2.5% polyacrylamide hydrogel demonstrated sustained improvements in WOMAC pain, stiffness, physical function, and PGA for up to five years, with a favourable safety profile. These findings support its potential as a long-term treatment option for knee osteoarthritis. Trial registration ClinicalTrials.gov Identifier: NCT04179552.

OBJECTIVE To assess the efficacy and safety of sulphasalazine in reactive arthritis. METHODS Double blind placebo controlled trial of six months duration comparing sulphasalazine 2-3 g per day (n = 37) with matching placebo (n = 42) in adults with active reactive arthritis (age 19-57 years, median 34). Treatment response was evaluated once a month by changes in erythrocyte sedimentation rate (ESR), pain, peripheral arthritis, tender iliosacral joints, entesopathy, extra-articular manifestations, and working ability. RESULTS 15 patients in the sulphasalazine group and eight in the placebo group withdrew from the study prematurely. Adverse events, primarily gastrointestinal, were the main reason for withdrawal in the actively treated group. Intention-to-treat analyses showed significant improvements over time in both groups in ESR, pain, and number of swollen joints (P < 0.01). Number of days on sick leave decreased significantly in the sulphasalazine group only (P < 0.01). No significant differences between the two groups were present after six months. Among the patients completing the trial according to protocol, persistent complete remission had occurred within two months in five (23%) of the actively treated, but in no placebo treated patients (P = 0.013). CONCLUSIONS Sulphasalazine seemed to improve only the very short term outcome of reactive arthritis. The possible beneficial effect of the drug should also be weighed against the risk of adverse events. Although these were mainly mild, almost 25% of the patients in the actively treated group gave up treatment for this reason.