OP0011 EFFECT OF LIRAGLUTIDE ON BODY WEIGHT AND PAIN IN THE TREATMENT OF OVERWEIGHT AND KNEE OSTEOARTHRITIS: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Abstract

Background: Weight loss is recommended as treatment of concomitant knee osteoarthritis (OA) and overweight. The GLP-1 receptor agonist liraglutide has been shown effective in maintaining or even further reducing weight loss, but the compound has not been tested in a population of patients with overweight and knee OA. Objectives: The objective of this trial was to investigate if liraglutide in a 3 mg/day dosage was effective in maintaining weight loss and symptomatic effects 52 weeks after an initial 8-week dietary-based weight loss intervention dosing in patients with overweight and knee OA. Methods: Patients with overweight or obesity and knee OA participated in a randomised, double blind, placebo-controlled, parallel group, single-centre trial. Patients were provided an initial 8-week run-in diet intervention (week -8 to 0) including a low-calorie diet from Cambridge Weight Plan and dietetic counselling. At week 0 patients who had lost at least 5% of their initial body weight were randomised to liraglutide 3 mg/day or placebo for 52 weeks. The co-primary outcomes were changes in body weight and the KOOS pain subscale from week 0 to 52. Trial registration: NCT02905864. Analyses were based on the intention-to-treat population. (Image Presented) Participants analysed in the primary analysis (N=80) Participants analysed in the primary analysis (N=76) Results: 168 patients (Kellgren-Lawrence grade 1-3) were enrolled in the initial 8-week diet intervention and 156 patients were randomised (Figure 1). Before randomisation the 156 patients had lost 12.46 kg (SD:3.82) (»12%) and improved in KOOS pain corresponding to 11.86 points (SD:15.13) (»19%). Baseline characteristics were similar in the intervention and control groups. From baseline to 52 weeks there was a statistically and clinically significant difference in the weight loss between the liraglutide and the placebo groups (mean -2.76 and 1.17 kg, respectively; group difference, 3.93 kg; 95%CI -6.85 to -1.02; p=0.008), there was no difference between groups in change in KOOS pain (mean changes: 0.35 and -0.55 points, respectively; group difference, 0.89 points; 95%CI -3.89 to 5.68; p=0.713). Week 52 least squares means for body weight and KOOS pain showed similar results (Figure 2). 4 patients in the intervention and 4 patients in the control groups experienced serious adverse events, and no deaths were observed. Conclusion: In overweight patients with knee OA, an 8-week low-calorie diet intervention significantly reduced body weight and knee pain. Liraglutide treatment added after the initial diet-induced weight loss provided further weight loss over 1 year but did not reduce knee pain any further compared to placebo.