- Two-year efficacy and safety data analyses from Phase III
SUNSHINE and SUNRISE trials of continuous Cosentyx®
(secukinumab) treatment in HS to be presented
- New analyses of 52-week data from Phase III REMIX
pivotal trials of investigational remibrutinib,
demonstrating impact in key clinical outcomes for patients with CSU
also to be presented
- Regulatory submissions for remibrutinib as a treatment for
CSU on track for filing in 1H 2025
EAST
HANOVER, N.J., Feb. 28,
2025 /PRNewswire/ -- Novartis announced today it will
present data from 17 abstracts, including investigator-initiated
trials, across its immunology portfolio at the 2025 American
Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress and the 2025 American Academy of
Dermatology (AAD) Annual Meeting.
Data presented at the congresses include long-term urticaria
control, sleep, and activity analyses from the Phase III REMIX-1
and REMIX-2 studies evaluating investigational remibrutinib for the
treatment of chronic spontaneous urticaria (CSU). Additionally,
long-term data from the Cosentyx® (secukinumab) Phase
III SUNSHINE and SUNRISE trials in patients with hidradenitis
suppurativa (HS) and patient-reported outcomes from a Phase II
trial evaluating remibrutinib in HS will be presented.
"Conditions like CSU and HS are more than just skin deep, often
having a profound impact on patients' daily lives and activities,"
said Angelika Jahreis, Global Head,
Development, Immunology, Novartis. "These data at AAAAI and AAD
highlight our continued commitment to reimagine medicine and
address treatment gaps for people with immune-mediated diseases. We
are particularly excited about the potential for remibrutinib as a
novel oral treatment for patients with CSU who remain symptomatic
on antihistamines."
These CSU data will support regulatory submissions in the first
half of 2025. In addition to CSU, remibrutinib is being
investigated in other immune-mediated conditions, including chronic
inducible urticaria (CIndU), HS, and food allergy.
Key abstracts accepted by AAAAI include:
Abstract
Title
|
Abstract
Number/
Presentation Details
|
Remibrutinib
|
The Impact of
Remibrutinib on Urticaria Control in Patients with Chronic
Spontaneous Urticaria: Long-term Results from the REMIX-1/-2 Phase
3 Trials
|
Abstract #598
Oral Presentation
Saturday, March 1
2:35 – 2:45 PM PST
|
Remibrutinib Treatment
Has No Clinical Impact on Mean Blood Cell Counts in Patients With
Chronic Spontaneous Urticaria: Pooled
Safety Analysis From REMIX-1 and REMIX-2 Studies
|
Abstract #592
Poster Presentation
Sunday, March 2
9:45 – 10:45 AM PST
|
Key abstracts accepted by AAD include:
Abstract
Title
|
Abstract Number/
Presentation Details
|
Remibrutinib
|
Effect of Remibrutinib
on Sleep and Daily Activities in Patients With Chronic Spontaneous
Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies
|
Abstract #62278
e-Poster with Oral Presentation
Friday, March 7
4:55 – 5:00 PM EST
|
Improvements in Itch
and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients
With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2
|
Abstract #P62280
e-Poster Presentation
|
Effects of Remibrutinib
Treatment on Ambulatory Blood Pressure in Adult Patients With
Chronic Spontaneous Urticaria (CSU)
|
Abstract #62284
e-Poster Presentation
|
Remibrutinib in
patients with moderate to severe hidradenitis suppurativa: Patient
reported outcomes from a randomized, phase 2, double-blind,
placebo-controlled platform study
|
Abstract #62279
e-Poster Presentation
|
Cosentyx
|
The impact of
continuous secukinumab treatment between weeks 52–104 on draining
tunnels in patients with moderate to severe hidradenitis
suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE
extension trial
|
Abstract #63334
e-Poster Presentation
|
The impact of
continuous secukinumab treatment between weeks 52–104 on HiSCR75,
HiSCR90, and HiSCR100 in patients with moderate to severe
hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and
SUNRISE extension trial
|
Abstract #62149
e-Poster Presentation
|
Efficacy of secukinumab
uptitration from every 4 weeks to every 2 weeks dosing between
weeks 52-104 in week 52 HiSCR non-responder patients with moderate
to severe hidradenitis suppurativa: A post hoc analysis of the
SUNSHINE and SUNRISE extension trial
|
Abstract #63451
e-Poster Presentation
|
The impact of
continuous secukinumab treatment through week 104 on efficacy
outcomes in patients with moderate to severe hidradenitis
suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core
and extension trials
|
Abstract #64857
e-Poster Presentation
|
The impact of
continuous secukinumab treatment through week 104 on patient
reported outcomes in patients with moderate to severe hidradenitis
suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core
and extension trials
|
Abstract #64674
e-Poster Presentation
|
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