ART-QUALIVIE: improved quality of life of patients with knee osteoarthritis 6 months after treatment with three intra-articular injections of ARTHRUM H 2%. A French cohort-study

BACKGROUND: Knee osteoarthritis (KOA) may lead to a deterioration in patient’s quality of life (QoL). The objective of the ART-QUALIVIE study was to describe the effect of 3 intra-articular injections of ARTHRUM H 2% (a viscosupplement sterile preparation, containing 40 mg of high molecular weight hyaluronic acid per syringe), on the physical and mental components of QoL. The intention was to complete the results obtained on pain, function and OMERACT-OARSI responders, through other studies carried out on the same medical device.METHODS: A French observational, prospective, multi-center study was conducted between February 2016 and July 2017 in 134 adult patients with primary KOA treated with 3 intra-articular injections of ARTHRUM H 2%. Their baseline characteristics - mean (±SD) - were: age of 66.4 years (±10.7); majority female (66.4%); BMI 28.7 (±5.3) kg/m2 (43.3% overweight and 35.1% obese); KL grade: I 13.6%, II 40.2%, III 46.2%; Respectively 6.7% and 44.8% of patients had previously received physical therapy or viscosupplementation (VS) (2.2 treatments on average, the last at one year). The primary endpoint was the change from baseline at 6 months, in the physical component summary score (PCS) of the validated SF-12 QoL questionnaire. Out of these patients, 115 were evaluable for the primary outcome criterion. Logistic regression analyses were used to identify the mains drivers of significant increase of physical summary score, adjusted for sociodemographic and health covariates.RESULTS: A clinically and statistically significant improvement in the QoL of patients was observed with an increase of the PCS from 40.0 at baseline, to 44.8 at 6 months (P<0.001), the improvement being reached during the first 3 months following VS and maintained up to 6 months after baseline. The secondary outcomes, mental component summary score (MCS) of the QoL, and WOMAC A pain sub-score were also significantly improved. Baseline factors found to be associated with an improvement in QoL were: KL III grade KOA (OR=5.254, P=0.032), KL II grade KOA (OR=3.507, P=0.100), lateral femorotibial osteoarthritis (OR=3.175, P=0.029) and a single history of VS (OR=2.936, P=0.044). A post-hoc comparison confirmed the non-inferiority of ARTHRUM H 2% vs HYLAN G-F 20 for both PCS and MCS.CONCLUSIONS: ART-QUALIVIE, a French study providing real-world data on the evolution of QoL of viscosupplemented KOA patients shows a positive impact of ARTHRUM H 2% on patient’s QoL over the first 3 months following injections, improvement maintained until six months after treatment.