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Trial results show second HA-steroid injection is safe for patients with knee OA
Patients in the trial were treated with an injection of sodium hyaluronate with triamcinolone hexacetonide after a previous active or placebo injection.
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In results of the phase 3 trial of repeat injections of crosslinked sodium hyaluronate combined with triamcinolone hexacetonide for osteoarthritis of the knee, investigators found a second injection was associated with few adverse events among the patients enrolled in the trial.
According to László Hangody, MD, PhD, DSc, who is global principal investigator of both of the European phase-three trials of Cingal (crosslinked sodium hyaluronate and triamcinolone hexacetonide, Anika Therapeutics) conducted to date, the most recent study — called 13-02 — was designed to assess the safety of a single repeat injection of crosslinked sodium hyaluronate and triamcinolone hexacetonide to treat osteoarthritis (OA) of the knee.
In the first study, called 13-01, patients were randomized to receive an injection of crosslinked sodium hyaluronate and triamcinolone hexacetonide, Monovisc (high-molecular-weight hyaluronan, DePuy Synthes) or placebo (saline). The investigators found treatment with crosslinked sodium hyaluronate and triamcinolone hexacetonide was statistically and clinically superior to placebo for all endpoints, Hangody said.
“Both studies found Cingal to have an excellent safety profile and to be tolerable, with the frequency and type of adverse events (AE) to be consistent with other viscosupplementation products. These include arthralgia, injection site pain, swelling, redness and rash, all of which resolved without treatment. The most common AEs reported in both Cingal 13-01 and 13-02, which were primarily mild and transitory in nature, were headache, arthralgia, spinal pain/back pain and nasopharyngitis (common cold). The events were distributed proportionally among the Cingal, Monovisc and saline arms in Cingal 13-01,” Hangody told Orthopaedics Today Europe.
Pain and AEs
Investigators for the 13-02 study began enrolling patients 5 months after completion of the 13-01 trial. Its primary outcome was the comparison of the AEs in the two phases of the trial.
The 13-01 trial used the WOMAC score as the primary endpoint. Results for crosslinked sodium hyaluronate and triamcinolone hexacetonide showed 68% improvement in WOMAC pain scores during the first few weeks, and 72% improvement at 26 weeks, according to Hangody.
The 13-02 study used AEs as its primary endpoint. It included 242 patients from the 13-01 study who previously received an initial injection of either crosslinked sodium hyaluronate and triamcinolone hexacetonide, high-molecular-weight hyaluronan or saline.
“The hyaluronic acid (HA) found in Monovisc is a highly purified, partially crosslinked sodium hyaluronate that provides pain relief that lasts up to 6 months. By combining the crosslinked HA formulation of Monovisc with the steroid, triamcinolone hexacetonide, Cingal provides a short-term, statistically significant improvement in pain reduction during the first 3 weeks following treatment compared to Monovisc, with long-term statistically significant improvement over placebo for 26 weeks,” Hangody said.
No difference in AEs
The results showed 6.2% of patients experienced an AE following a repeat injection of the HA combined with steroid. The AEs were typical of viscosupplements, such as arthralgia, injection site pain, swelling and erythema. More than 95% of AEs were considered mild or moderate in severity, according to a press release from Anika Therapeutics.
The AEs associated with the combination treatment, however, were similar across both phases of the trial with no statistically significant differences in AE rates between the patients who received a single injection of the treatment and those who received repeat injections, as noted in the release.
Knee replacement unnecessary
During the 13-02 study follow-up, Hangody said none of the patients required a total knee replacement (TKR).
“The decision on whether and when a patient should undergo TKR involves a variety of factors, which need to be assessed throughout the course of care. What we do know is that viscosupplementation can be an effective option to help some patients manage pain from knee OA and resume their day-to-day function. The Cingal data have shown that an initial single injection is effective in treating the pain of knee OA for 26 weeks, and that both the initial injection and repeat injection of Cingal present excellent safety profiles,” he said. – by Robert Linnehan
- For more information:
- László Hangody, MD, PhD, DSc, can be reached at Department of Orthopaedics and Traumatology, Uzsoki Hospital/Semmelweis University, 1145 Budapest, Uzsoki, u. 29, Hungary; email: hangody@t-online.hu.
Disclosure: Hangody reports he is compensated by Anika Therapeutics for performing the duties of Global PI, National Coordinating PI and as an investigator for the study, however, the value of the compensation was not influenced by study outcome.