These are very encouraging results for SLE patients, they noted in a news release.
Lupus is an autoimmune disease, which means that it is not caused by an external pathogen. Photo: Shutterstock.
Deucravacitinib y orelabrutinibtwo new investigational oral drugs for the treatment of lupus systemic erythematosus (SLE), have performed well in early clinical trials.
In the phase 2 PAISLEY study, up to 58% of patients treated with deucravacitinib vs. 34% of placebo-treated patients met the study’s primary endpoint of SLE Response Rate 4 (SRI-4) after 38 weeks of treatment. Deucravacitinib it also “met or significantly improved” all established secondary endpoints in the 363-patient trial and was reported to have a safety and tolerability profile that was generally similar to placebo, according to late-breaking abstracts in Congress European Annual of Rheumatology.
“Deucravacitinib shows promise as a novel therapy for SLE and warrants further investigation in phase 3 trials,” said Eric F. Morand, a clinical rheumatologist and director of the School of Clinical Sciences at Monash University in Melbourne.
In an ongoing independent Phase 1b/2a study designed to evaluate orelabrutinib As a potential treatment for SLE, no safety concerns were seen with the investigational drug, along with a “trending efficacy,” which supports “further study in larger, longer-term trials,” according to the study’s investigators.
“What distinguishes these two new drugs from currently available targeted therapies is their mode of action,” said Dr. Yuzaiful, who was not involved in either study.
“The results of the PAISLEY study are promising, and it is good to see that the patients recruited were of diverse ethnicities [entre el 50 % y el 60 % eran blancos]added Dr Yusof, Senior Research Fellow at the Institute of Rheumatic Diseases, Leeds, England, and Consultant Musculoskeletal Medicine and Rheumatologist at Leeds Teaching Hospitals NHS Trust.
He noted that the placebo rate was also low: “This could be contributed to by keeping the background prednisolone dose low, which is often a challenge in SLE trial design.”
First days for both agents
While both currently look promising, it is too early to deucravacitinib y orelabrutinib as potential new agents for SLE.
Apart from the LES, the deucravacitinib it is being tested in multiple immune-mediated diseases. This includes psoriasis, where two phase 3 trials, POETYK PSO-1 and POETYK PSO-2, have already been completed, and psoriatic arthritis, where one phase 2 trial has been reported; all with positive results.
Phase 3 testing of deucravacitinib they will go ahead and recruitment may begin later this year, but the studies will take years to complete, Morand said. Even if the trials come back positive, neither agent will be available for clinical use for several years.
An example of this is anifrolumab (Saphnelo), whose evaluation Morand participated in. Despite gaining approval in the United States and much of the world, the drug is still in the process of being reimbursed.
“The trial data and many post hoc analyzes clearly show that this is a major step forward in the treatment of lupus“, he said in an interview, but “access is limited in most places, so you need to have hands-on experience with that new treatment,” still limited for most doctors.”
As for all the other new targeted approaches being investigated, “Although there is a lot of trial activity, it’s still a couple of years before any of the current trials will provide a new treatment. That is if they provide positive findings. In fact.” , there have been numerous agents that have shown promise in phase 2 but then fall at the final hurdle of phase 3, including baricitinib, which Morand reported on in a separate poster presentation.
The Phase 3 data was disappointing: “The results are not positive enough for that to move forward,” he said, adding that “the transition from a successful Phase 2 to a successful Phase 3 is challenging, and many products have failed.” “.
Morand added: “It’s a very exciting time to be in the investigation of the lupus, and there is a lot of optimism about the future. But when I go back to my clinic tomorrow, I treat my patients exactly the same as last week and last year.”
It remains to be seen if the deucravacitinib will deliver on its initial promise, but is off to an impressive start. A positive aspect for patients is that it is an oral drug, with the potential to improve access to treatment throughout the world, where receiving infusions can be a problem.
“This is some of the most exciting data I’ve seen at the phase 2 level in terms of the effect size across all the readouts that are used,” Morand said. “There’s no guesswork here; it worked on all measures. That’s very reassuring.”
consulted source here.