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Data from the phase 3 TULIP long-term extension trial support the favorable benefit-risk profile of anifrolumab-fnia demonstrated in previous trials.
In an interview with HCPLive, Micki Hultquist, MS, vice president, global franchise head at AstraZeneca, discusses the phase 3 TULIP program, which evaluated the efficacy and safety of anifrolumab-fnia (Saphnelo) treatment in patients with systemic lupus erythematosus (SLE).1
What inspired your team to evaluate long-term treatment with anifrolumab-fnia in this patient population?
SLE is a serious and complex chronic autoimmune condition characterized by periods of relapse and remission, with patients often experiencing inadequate disease control. This can lead to poor health-related quality of life, increased absenteeism from work, and reduced productivity, with disability at work associated with pain, fatigue, depressive symptoms, and cognitive dysfunction.
Given the chronic nature of SLE, many patients will require treatment throughout their lifetime, making it important to understand the long-term safety and tolerability of any treatment given.
By evaluating long-term treatment with Saphnelo, we aimed to provide further evidence of its long-term safety and tolerability. TULIP LTE is the longest placebo-controlled clinical trial performed in SLE to date and these findings provide an extensive data set accumulated over four years.
With Saphnelo, and across our portfolio in immunology, we remain focused on our ambition to challenge current treatment expectations and help establish remission as an achievable treatment goal for as many patients as possible.
Can you give me a bit of background on the TULIP Phase 3 program?
All 3 TULIP trials that were part of the Phase 3 program for Saphnelo (TULIP-1, TULIP-2, and TULIP-LTE, or long-term extension) were randomized, double-blinded, placebo-controlled trials in patients with moderate to severe SLE who were receiving standard therapy.
TULIP-LTE investigated the long-term safety and tolerability of Saphnelo compared with placebo in 559 enrolled patients with moderate to severe SLE who had previously completed a Phase 3 study for an additional 3 years.
The placebo arm of the trial included at least 1 of the following standard therapies: oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil).
In the post-hoc analysis presented at the American College of Rheumatology’s 2023 Convergence, 369 patients (anifrolumab 300 mg, n = 257; placebo, n = 112) who continued treatment in TULIP-LTE were analyzed for the 4-year TULIP-LTE period.
At 4 years, TULIP-LTE is the longest placebo-controlled clinical trial performed in SLE to date and supports the favorable benefit-risk profile of Saphnelo seen in previous trials.
What were the key findings?
At the end of the 4-year TULIP program (week 208), 33% (n = 63/194) of patients treated with Saphnelo were in remission compared with 21.4% (n = 14/65) on standard therapy alone.
In addition, patients treated with Saphnelo spent a greater percentage of time in remission (17.2% vs 8.3%; 95% confidence interval [CI] 3.2 - 14.5; P = .0022) and were more likely to sustain remission for three or more visits vs standard therapy alone (30.2% vs. 17.2%; 95% CI 1.2 - 3.6; P = .0127).
These data are exciting as they demonstrate that remission is an achievable therapeutic goal with long-term Saphnelo use.
What is the clinical significance of these results?
These data show that compared to standard therapy alone, patients are more likely to achieve and sustain remission in SLE with Saphnelo. We see higher rates of patients with no disease activity while bringing oral corticosteroid use to the guidelines-recommended threshold, a real step forward for SLE treatment.
These data are exciting because they support our bold ambition to transform care in immunology. We’re targeting diseases with high unmet need where patients remain uncontrolled, to dramatically shift how patients are treated today and in the future.
What are the next steps for your team?
Additional phase 3 trials are planned investigating Saphnelo in diseases where type 1 interferon plays a key role, including systemic sclerosis, cutaneous lupus erythematosus, and myositis.
Saphnelo continues to be evaluated in the TULIP-SC phase 3 trial assessing subcutaneous delivery in SLE, the AZALEA phase 3 trial in SLE in China, and the IRIS phase 3 trial in lupus nephritis.