Background/Purpose: In osteoarthritis (OA) treatment, although chondroitin sulfate (CS) was found in a number of studies using radiography to have a structure modifying effect, to date the question is still under debate. A clinical study using quantitative magnetic resonance imaging (qMRI) is therefore of the utmost importance.

The present study has the objective to explore, as the first aim, in a two-year randomized, controlled double-blind clinical study (RCT) using qMRI, the disease modifying effect of CS treatment versus celecoxib (CE) on cartilage volume loss (CVL) in knee OA. The second aim was to investigate and compare the effect of CS and celecoxib on symptoms.

Methods: Symptomatic primary knee OA patients according to ACR criteria with Kellgren-Lawrence grades 2-3 and synovitis were included and treated with CS (1200 mg a day) or CE (200 mg once daily) for 24 months. Patients at high risk for cardiovascular and/or gastrointestinal disease were not included. MRI was performed at baseline, 12 and 24 months. CVL, bone marrow lesion (BML) size, and synovial membrane thickness were evaluated using qMRI, and presence of joint swelling and effusion clinically evaluated. Clinical symptoms were also assessed by validated questionnaires. Statistical analyses were done on the intention-to-treat (ITT) population (n=194 patients), per protocol set (n= 195) and the according-to-protocol completer population (n=120) using Student’s t-test, Wilcoxon Mann-Whitney test, and ANCOVA.

Results: In the ITT population, OA patients treated with CS (n=97) had a reduction in CVL at 12 months (p=0.017) and 24 months in the medial tibiofemoral compartment (p=0.013) and global knee at 12 (p= 0.034) and 24 months (p=0.054) compared to CE (n=97). No difference in change in synovial thickness or BML size between the two treatment groups was observed over time. A marked reduction in the incidence of patients with joint swelling plus effusion was observed in both the CS (51%, 59 vs 6 patients) and celecoxib (39%, 55 vs 11 patients) groups from baseline to 24 months, without differences between treatments. Both therapeutic groups experienced a reduction in disease symptoms (WOMAC total, pain, and function, and VAS pain) over time: reduction in VAS pain at 24 months for CS and celecoxib was 48% and 55% respectively, and for WOMAC pain 43% and 54%. The overall daily consumption of rescue analgesic (acetaminophen) was not different between CS and celecoxib (584 vs 472 mg/day) groups. The incidence of adverse events was similar in both treatment groups.

Conclusion: This trial demonstrated, for the first time, the superiority of CS over CE at reducing the long term progression of knee OA structural changes. Moreover, both drugs were found equally effective at reducing the symptoms of OA. These findings have important implications regarding the usefulness of CS for long term management of knee OA and its impact on disease outcome.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/in-a-two-year-double-blind-randomized-controlled-multicenter-study-chondroitin-sulfate-was-significantly-superior-to-celecoxib-at-reducing-cartilage-loss-with-similar-efficacy-at-reducing-disease-sym/