AstraZeneca at ACR 2023 presented 18 abstracts from its respiratory and immunology pipelines
Micki Hultquist in a stimulating conversation with PharmaShots sheds light on Saphnelo, AstraZeneca’s first-in-class biologic treatment for systemic lupus erythematosus (SLE)
The post-hoc analysis of the TULIP P-III program reveals that the patients showcased more frequent and sustained remission as compared to standard therapy is among 13 publications related Saphnelo
Saurabh: As the company has already planned to present 18 abstracts from its respiratory and immunology pipeline, could you brief us all about it?
Micki: We are really excited about the strong presence from AstraZeneca at ACR this year. We’re presenting data across our portfolio, including from Saphnelo, our first-in-class biologic treatment for systemic lupus erythematosus (SLE), as well as late-breaking full results from the Phase 3 MANDARA trial in EGPA from Fasenra.
Importantly, a new post-hoc analysis of the TULIP Phase III program shows that Saphnelo, a first-in-class biologic, is associated with more frequent and sustained remission versus standard therapy alone. These data are important because SLE is a serious and complex autoimmune condition that can affect any organ. Patients often experience inadequate disease control, and despite advances in therapies, feMaw experience remission.
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.
Full abstract list below:
Presenting author
Abstract title
Presentation details
SAPHNELO (anifrolumab-fnia)
Furie, RA
Renal Involvement in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
0582–0608
Poster Session A
12 November 2023
9:00-11:00 PST
Furie, RA
Efficacy of Anifrolumab in Systemic Lupus Erythematosus by Overall and Organ-Specific SLEDAI-2K Improvements: Results from the Randomized, Placebo-Controlled Phase 3 Long-Term Extension Study
0582–0608
Poster Session A
12 November 2023
9:00-11:00 PST
Strand, V
Evaluation of Anifrolumab Treatment Responses by the Short Form 36 Health Survey Version 2 in SLE: A Post Hoc Analysis of the Placebo-Controlled Phase 3 Long-Term Extension Trial
0582–0608
Poster Session A
12 November 2023
9:00-11:00 PST
Aringer, M
Real-World Treatment Patterns in Patients with Systemic Lupus Erythematosus: An Analysis of the SLE Prospective Observational Cohort Study (SPOCS)
0582–0608
Poster Session A
12 November 2023
9:00-11:00 PST
Hasni, S
Multi-Omic Profiling Reveals Immune Cell Priming Signature Linked to Systemic Lupus Erythematosus Prognosis
Abstract Session
13 November 2023
16:00-17:30 PST
Lim, SS
Using Patient Self-Reported Measures to Predict All-Cause Hospitalization in a Population-Based Lupus Cohort
1200-1220
Poster Session B
13 November 2023
9:00-11:00 PST
Lim, SS
Using Patient-Reported Disease Activity in a Population-Based Cohort to Predict Systemic Lupus Erythematous Hospitalization and Emergency Room Visits
1200-1220
Poster Session B
13 November 2023
9:00-11:00 PST
Kyttaris, V
Characteristics and Prior Treatment Journey of Systemic Lupus Erythematosus (SLE) Patients Who Were Prescribed Anifrolumab – Observations from the American Rheumatology Network (ARN) in the U.S.
1488-1512
Poster Session B
13 November 2023
9:00-11:00 PST
Vollenhoven, RV
Remission Attainment in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
2326–2351
Poster Session C
14 November 2023
9:00-11:00 PST
Furie, RA
Organ Damage Progression in Systemic Lupus Erythematosus: An Analysis of the SLE Prospective Observational Cohort Study (SPOCS)
2257–2325
Poster Session C
14 November 2023
9:00-11:00 PST
Morand, E
Disease Activity Progression in Systemic Lupus Erythematosus: An Analysis of the SLE Prospective Observational Cohort Study (SPOCS)
2257–2325
Poster Session C
14 November 2023
9:00-11:00 PST
Jayne, D
Identification of Urine Metabolites Linked to Disease Activity That Are Modulated by Anifrolumab in a Phase 2 LN Trial Using Untargeted Metabolomics Analysis
2326–2351
Poster Session C
14 November 2023
9:00-11:00 PST
Mamani, IL
Proposal for Defining Moderate and Severe Activity States in Systemic Lupus Erythamatosus. Impact On Flares and Other Outcomes
2257-2325
Poster Session C
14 November 2023
9:00-11:00 PST
Saurabh: As we all heard the P-III (TULIP) program will be presented at ACR 2023, give us more information regarding the study & its design?
Micki: This new post-hoc analysis of the TULIP Phase III program provides evidence across four years that remission is an achievable goal with Saphnelo (anifrolumab), a first-in-class biologic for patients living with systemic lupus erythematosus (SLE). Saphnelo is the first biologic with remission data from a four-year placebo-controlled trial.
At the end of the four-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% CI 3.2-14.5; p=0.0022) 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=0.0127).
These data are exciting as they demonstrate that remission is an achievable therapeutic goal with Saphnelo. In lupus, remission is associated with reduced organ damage, fewer flares, reduced hospitalization, reduced mortality and improved health-related quality of life.
All three TULIP trials 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. The placebo arm of the trial included at least one of the following standard therapies: OCS, antimalarials and immunosuppressants (methotrexate, azathioprine or mycophenolate mofetil).
Saurabh: Remission is crucial to improve the quality of life for SLE patients. Let us know how the firm is going to challenge the existing framework and make remission a realistic objective?
Micki: Our ambition is to disrupt Immunology by achieving increased rates of remission in under-served diseases and bringing in a new generation of therapeutics, aiming to reverse and repair damage, treat patients earlier, modify the natural course of the disease, and one day potentially offer a cure.
In lupus, remission is associated with reduced organ damage, fewer flares, reduced hospitalization, reduced mortality and improved health-related quality of life.
The new post-hoc analysis of the TULIP Phase III program presented at ACR 2023 provides evidence across four years that remission is an achievable therapeutic goal with Saphnelo. In the analysis, remission was defined using the DORIS criteria (Definition of Remission in SLE): no disease activity assessed by two measures of disease activity across organ systems (total SLEDAI-2K, or “Systemic Lupus Erythematosus Disease Activity Index 2000” score, and the physician global assessment), oral corticosteroid (OCS) dose of <5 mg per day, and no use of restricted medicines.
Recent recommendations from the European Alliance of Associations for Rheumatology (EULAR) advise taking an OCS-sparing approach to the management of SLE, with early use of biologics to achieve remission or lower disease activity, preserve renal function, and reduce flares and organ damage.
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.
Saurabh: Saphnelo was studied against the standard treatment alone, & and the result showed significant data regarding the remission, can you let us know the exact data of the study?
Micki: The TULIP-LTE study concluded in 2022. This post-hoc analysis of the TULIP program, presented at ACR 2023, shows that at the end of the four-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% CI 3.2-14.5; p=0.0022) 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=0.0127).
These data are exciting as they demonstrate that remission is an achievable therapeutic goal with long-term Saphnelo use.
Saurabh: The study (TULIP) was done for an extensive four years, what was the study design?
Micki: 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 III study (TULIP-1 or -2) for an additional three years.
In the post-hoc analysis presented at ACR, 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 four 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.
