TULIP: Anifrolumab superior to standard of care for lupus regardless of prior biologic use
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A 300-mg dose of anifrolumab provided clinically meaningful benefit and was generally well-tolerated among patients with systemic lupus erythematosus, regardless of previous exposure to biologic agents, according to data presented at ACR Convergence 2021.
“Clinicians are concerned about two things in people who have been on previous biologics: First, the safety of sequential exposure to biologics, and second, whether someone that did not respond to one biologic may also not respond to another,” Susan M. Manzi, MD, MPH, professor of medicine and chair of the Medicine Institute at Allegheny Health Network, told Healio Rheumatology. “These data suggest that both concerns are unfounded.”
To determine whether prior biologic exposure impacted anifrolumab efficacy and safety, Richard Furie, MD, chief of the division of rheumatology at Northwell Health, and professor of medicine at Hofstra/Northwell School of Medicine in New York, and colleagues analyzed pooled data from the TULIP-1 and TULIP-2 trials among patients with SLE who received IV anifrolumab (Saphnelo, AstraZeneca) 300 mg or placebo.
Eligible patients included those who met the ACR 1997 criteria for SLE, exhibited moderate to severe disease, and were permitted previous biologic use with a 3- to 6-month “washout” period. Patients were divided into biologic-experienced (n = 145) or biologic-naïve subgroups (n = 581), with the majority of prior biologic use attributed to belimumab (n = 70), epratuzumab (n = 49), tabalumab (n = 18) or rituximab (n = 14).
The researchers examined efficacy measures including BILAG–based Combined Lupus Assessment (BICLA) response, SLE Responder Index of 4 response, sustained oral glucocorticoid taper and annualized flare rate through week 52. Furie and colleagues assessed binary endpoints and safety with a Cochran–Mantel–Haenszel approach, and used a negative binomial regression model to examine annualized flare rate.
“Patients receiving anifrolumab following exposure to another biologic were not at higher risk of a serious adverse event as compared to those receiving standard of care,” Manzi said. “Patients that did not respond or did not tolerate a previous biologic were just as likely to respond to anifrolumab as those that did not receive a previous biologic.”
Although the baseline demographics, disease characteristics and non-biologic SLE treatments were comparable between the two groups, biologic-experienced patients were more likely to be from U.S./Canada, exhibited longer times from SLE diagnosis, a SLICC/ACR Damage Index score 1, anti-dsDNA antibodies and interferon gene signatures, and were less likely to have swollen/tender joints vs. biologic-naïve patients.
In addition, the researchers reported lower placebo responses in biologic-experienced vs. biologic-naïve patients. Anifrolumab was linked to comparable/greater treatment differences over placebo in biologic-experienced compared with biologic-naïve patients across endpoints, including BICLA, SRI(4) and glucocorticoid tapers.
“Anifrolumab provided benefit over ‘standard of care’ in both those with or without prior exposure to biologic agents,” Manzi told Healio Rheumatology. “Anifrolumab is an option for patients refractory to other biologics [as] the safety profile of anifrolumab was no different in those who had been or those who had not been on previous biologic agents. It is a finding that is reassuring. We have only had one biologic approved for lupus (belimumab) prior to anifrolumab, so previous experience is limited.”
Furie and colleagues noted that the incidence of serious adverse events was higher in biologic-experienced compared with biologic-naïve patients with anifrolumab and placebo; in particular, the incidence of herpes zoster was found to be higher with anifrolumab compared with placebo in both groups.
“These data suggest that prior use of biologics should not preclude using anifrolumab in patients with active lupus,” Manzi said. “These data open the door for many patients who need additional treatment for active disease; we do not have to exclude those that were on previous therapies including biologics.”
She added that if rheumatologists “have a patient with active lupus refractory to other biologic agents, they can consider using anifrolumab since the benefit-risk ratio is favorable. Previous use of biologics does not appear to impact safety or efficacy.”
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Furie R. Abstract 1740. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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