A small molecule already approved in China for patients with moderate to severe SLE has demonstrated clinical efficacy in patients with RA and an inadequate response to methotrexate.
Speaking in the late-breaking session (link) at ACR Convergence, Dr Qing Zuraw said telitacicept was a novel recombinant fusion protein which is a dual inhibitor of B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
Dr Zuraw, from RemeGen Biosciences in the US, presented the results from a phase 3 RCT comparing response to weekly subcutaneous injections of telitacicept or placebo in 479 adult patients without exposure to bDMARDs in the past six months.
She said the primary endpoint of ACR20 at week 24 was achieved by significantly more patients in the telitacicept group than the control group (60% v 26.9%; p <0.001).
As well, a secondary endpoint of ACR50 was achieved by significantly more patients in the telitacicept group than the control group (21.4% v 5.9%; p<0.001).
The same pattern was apparent for the secondary outcome of ACR70 (5.0% v 1.7%) however the small numbers meant the difference did not hit statistical significance.
In other secondary outcomes, significantly more patients treated with telitacicept achieved DAS28-ESR than controls (14.7% v 5.0%; p<0.05) and a reduction from baseline in DAS28-ESR (-1.58 v -0.97; p<0.001).
Further, significantly more patients in the telitacicept group had improvements in HAQ-DI score, Patient’s Assessment of Pain, Patient’s Global Assessment of Disease Activity, Physician’s Global Assessment of Disease Activity, and reduction in ESR.
Dr Zuraw said there were some “really exciting results” regarding the impact on structural damage with significantly more patients in the telitacicept group showing less joint damage progression radiographically at week 24 than the control group.
Changes in the Modified Total Sharp Score, joint space narrowing and erosion scores were significantly less with telitacicept than placebo.
She said the study found the groups were very similar in terms of treatment emergent adverse events (79.7% v 77.3%), serious adverse events (6.4% v 6.7%) and TEAE’s leading to discontinuation (3.9% v 3.4%),
There were no deaths in either group and infections/infestations (41.1% v 42.0%) and serious infections (2.2% v 3.4%) occurred at similar rates.
Dr Zuraw said there were some limitations in the trial including the lack of an active comparator and the fact the study was conducted in a Chinese patient population which limited opportunities for racial diversity.
“Teltacicept demonstrated clinical efficacy with a favourable safety profile in patients with RA who have an inadequate response to methotrexate,” she concluded.
Telitacicept (BlyS/APRIL inhibitor) ph3 in RA
wholly in China, after SLE approval there (SLE trial now w global sites)Efficacy okay, no better than other b/tsDMARDs
What's the hook here, in a crowded RA market incl biosimilars?
Safety does look good though#ACR23 L20 @RheumNow pic.twitter.com/UzQ0f18E2A— David Liew (@drdavidliew) November 15, 2023