MUMBAI, India and PRINCETON, N.J., Oct.
9, 2019 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd.
(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715,
"Sun Pharma" including its subsidiaries and/or associate companies)
today announced that one of its wholly owned subsidiaries presented
long-term follow-up data from ILUMYA®
(tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the
28th European Academy of Dermatology and Venereology
Congress (EADV) in Madrid,
Spain.
The data showed that the significant response rates seen in the
initial 52 and 64 weeks, respectively, were maintained over four
years for people with moderate-to-severe plaque psoriasis, with
more than half of participants achieving at least 90 percent skin
clearance (Psoriasis Area Sensitivity Index (PASI) 90) and no new
safety concerns recorded.1,2 Additional study analyses
showed that the 75 to 100 percent skin clearance achieved with
ILUMYA treatment over three years was sustained equally in people
with and without metabolic syndrome,3,4 a common
condition in people with psoriasis.5
Click to Tweet #NEWS: @SunPharma_Live presents
long-term data showing significant skin clearance response
maintained in people with moderate-to-severe plaque psoriasis over
four years at #EADV2019. Read more:
https://bit.ly/2F4CEoo
"Psoriasis is an individualized condition and it can be a
challenge for clinicians to prescribe a medicine that's effective
over time, especially for patients with co-morbid conditions like
metabolic syndrome," said Jeffrey
Crowley, M.D., Bakersfield Dermatology, Bakersfield, California. "These data provide
confidence that ILUMYA can help patients with moderate-to-severe
plaque psoriasis, regardless of metabolic syndrome, achieve and
maintain significant skin clearance over the long-term."
Eligible participants in the ILUMYA Phase 3 reSURFACE 1 and 2
trials who remained on treatment for the open-label extension
studies received ILUMYA for a total of 208 weeks (reSURFACE 1) and
200 weeks (reSURFACE 2).1,2 After four years, ILUMYA
treatment led to significant and durable observed improvements in
PASI and Physician Global Assessment (PGA) scores – key measures of
disease severity.1,2
- ILUMYA 100 mg (reSURFACE 1, reSURFACE 2):
-
- PASI 75: 82 percent, 89 percent
- PASI 90: 56 percent, 64 percent
- PASI 100: 28 percent, 35 percent
- Percentage of participants with favorable PGA response: 58
percent, 65 percent
ILUMYA 100 mg was well-tolerated, with a low rate of adverse
events (AEs) that were comparable or numerically lower than placebo
based upon exposure-adjusted rates for many AE
categories.1,2
Researchers also analyzed the reSURFACE 1 and reSURFACE 2
studies to glean insights into whether ILUMYA's efficacy was
similar in people with metabolic syndrome (defined as elevated
blood pressure, body mass index/obesity, triglycerides and glucose
and low HDL cholesterol levels), as this co-morbid condition can
negatively affect people's response to most biologic psoriasis
medicines.6 This post-hoc analysis showed that the skin
clearance levels achieved and sustained with ILUMYA 100 mg at three
years were comparable in participants with and without metabolic
syndrome.3,4
- reSURFACE 1:
-
- PASI 75: 69 percent with metabolic syndrome; 71 percent without
metabolic syndrome
- PASI 90: 42 percent with metabolic syndrome; 51 percent without
metabolic syndrome
- PASI 100: 27 percent with metabolic syndrome; 23 percent
without metabolic syndrome
- reSURFACE 2:
-
- PASI 75: 73 percent with metabolic syndrome; 79 percent without
metabolic syndrome
- PASI 90: 57 percent with metabolic syndrome; 60 percent without
metabolic syndrome
- PASI 100: 34 percent with metabolic syndrome; 32 percent
without metabolic syndrome
Three-year adverse event rates usually associated with metabolic
syndrome, such as infections, cardiovascular events or
complications of diabetes, were no different in study participants
with and without metabolic syndrome.3,4
"Moderate-to-severe psoriasis is a lifelong condition, and at
Sun Pharma we're committed to helping people find treatment options
that work consistently over time, regardless of any co-morbid
conditions, to help manage the frustrating symptoms that for so
many years are a part of everyday life," said Alan Mendelsohn, M.D., Associate Vice President,
Dermatology Medical Affairs, Sun Pharma. "ILUMYA has been proven to
provide significant skin clearance that begins soon after initial
use and is maintained for years, with just four doses a year
following two starter doses, without demonstrating any new or
increased risk of safety events."
About the Studies
reSURFACE 1 Extension Study
reSURFACE 1 was a
three-part, double-blind, randomized, controlled, 64-week study
that evaluated ILUMYA 100 mg and 200 mg at weeks 0 and 4, and every
subsequent 12 weeks in adults with moderate-to-severe chronic
plaque psoriasis. Participants with at least 50 percent improvement
in PASI 50 at base study completion who received ILUMYA within 12
weeks of base study end (week 64) were eligible to enroll in the
extension study and continued on the same ILUMYA dose once every 12
weeks. Researchers evaluated PASI and PGA response (score of 0 or 1
with ≥2 grade reduction from baseline) and incidence rates for
prespecified adverse events, including severe infections,
cardiovascular events and drug-related hypersensitivities.
reSURFACE 2 Extension Study
reSURFACE 2 was a
three-part, double-blind, randomized, controlled, 52-week study
that compared the safety and efficacy of ILUMYA 100 mg and 200 mg
to placebo and etanercept 50 mg. At Week 12, patients with at least
a 50 percent improvement in PASI 50 at base study completion on
ILUMYA 100 or 200 mg were eligible to enroll in the extension study
and continued on the same ILUMYA dose every 12 weeks. Partial and
non-responders to etanercept were converted to treatment with
ILUMYA 200 mg, while responders (PASI ≥75) were discontinued.
Researchers evaluated PASI and PGA response (score of 0 or 1 with
≥2 grade reduction from baseline) and incidence rates for
prespecified adverse events, including severe infections,
cardiovascular events and drug-related hypersensitivities.
reSURFACE 1 and reSURFACE 2 Post-Hoc Analyses
Post-hoc
analyses of reSURFACE 1 and reSURFACE 2 were conducted to evaluate
changes in ILUMYA's efficacy in people with and without metabolic
syndrome, which was previously defined as those who met the
National Cholesterol Education Program-Adult Treatment Panel III
criteria (including elevated blood pressure, body mass index [BMI],
triglycerides, and glucose). Researchers stratified efficacy
results – determined by proportion of patients with at least PASI
75 and absolute and median percent PASI change from baseline – up
to week 148 in both studies.
About
ILUMYA® (tildrakizumab-asmn)
ILUMYA® (tildrakizumab-asmn) is a humanized lgG1/k
monoclonal antibody designed to selectively bind to the p19 subunit
of interleukin-23 (IL-23) and inhibit its interaction with the
IL-23 receptor, leading to inhibition of the release of
pro-inflammatory cytokines and chemokines. ILUMYA is indicated for
the treatment of adults with moderate-to-severe plaque psoriasis
who are candidates for systemic therapy or phototherapy, in
the United States. ILUMYA has also
been approved for moderate-to-severe plaque psoriasis in
Australia and under the brand name
ILUMETRITM in Europe.
INDICATION AND IMPORTANT SAFETY INFORMATION
ILUMYA (tildrakizumab-asmn) is indicated for the treatment of
adults with moderate-to-severe plaque psoriasis who are candidates
for systemic therapy or phototherapy.
CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious
hypersensitivity reaction to tildrakizumab or to any of the
excipients.
WARNINGS AND PRECAUTIONS:
Hypersensitivity: Cases of angioedema and urticaria
occurred in ILUMYA-treated subjects in clinical trials. If a
serious allergic reaction occurs, discontinue ILUMYA immediately
and initiate appropriate therapy.
Infections: ILUMYA may increase the risk of infection.
Treatment with ILUMYA should not be initiated in patients with a
clinically important active infection until the infection resolves
or is adequately treated. Consider the risks and benefits of
treatment prior to prescribing ILUMYA in patients with a chronic
infection or a history of recurrent infection. Instruct patients
receiving ILUMYA to seek medical help if signs or symptoms of
clinically important chronic or acute infection occur. If a patient
develops a clinically important or serious infection, or is not
responding to standard therapy, closely monitor and consider
discontinuation of ILUMYA until the infection resolves.
Pretreatment Evaluation for Tuberculosis: Evaluate
patients for tuberculosis (TB) infection prior to initiating
treatment with ILUMYA. Do not administer ILUMYA to patients with
active TB infection. Initiate treatment of latent TB prior to
administering ILUMYA. Consider anti-TB therapy prior to initiation
of ILUMYA in patients with a past history of latent or active TB in
whom an adequate course of treatment cannot be confirmed. Patients
receiving ILUMYA should be monitored closely for signs and symptoms
of active TB during and after treatment.
Immunizations: Prior to initiating therapy with ILUMYA,
consider completion of all age-appropriate immunizations according
to current immunization guidelines. Patients treated with ILUMYA
should not receive live vaccines.
Adverse Reactions: The most common (≥1%) adverse
reactions associated with ILUMYA treatment that were more frequent
than in the placebo group are upper respiratory infections,
injection-site reactions, and diarrhea.
Please click here for Full Prescribing Information
and Medication Guide.
About Sun Dermatology
Sun Dermatology (the branded dermatology division of a wholly
owned subsidiary of Sun Pharmaceutical Industries Inc.) is
committed to expanding its dermatology portfolio to bring
healthcare providers and patients around the world more treatment
options and ongoing support for conditions like moderate-to-severe
plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with
its subsidiaries, is ranked second in dermatology prescription
volume within the U.S. per IQVIA and is the fourth largest
specialty generic pharmaceutical company globally. In addition to
ILUMYA, Sun Dermatology is comprised of several branded products
with a focus on various dermatologic conditions.
About Sun Pharmaceutical Industries Ltd. (CIN -
L24230GJ1993PLC019050)
Sun Pharma is the world's fourth largest specialty generic
pharmaceutical company and India's
top pharmaceutical company. A vertically integrated business and a
skilled team enables it to deliver high-quality products, trusted
by customers and patients in over 100 countries across the world,
at affordable prices. Its global presence is supported by
manufacturing facilities spread across 6 continents and approved by
multiple regulatory agencies, coupled with a multi-cultural
workforce comprising over 50 nationalities. Sun Pharma fosters
excellence through innovation supported by strong R&D
capabilities across multiple R&D centers, with investments of
approximately 7% of annual revenues in R&D. For further
information, please visit www.sunpharma.com & follow us on
Twitter @SunPharma_Live.
Disclaimer
Statements in this "Document" describing the Company's
objectives, projections, estimates, expectations, plans or
predictions or industry conditions or events may be "forward
looking statements" within the meaning of applicable securities
laws and regulations. Actual results, performance or achievements
could differ materially from those expressed or implied.
References
- Crowley J, et al. Efficacy and Safety of Long-Term
Tildrakizumab for Plaque Psoriasis: 4-Year Results from reSURFACE
1. Presented at the European Academy of Dermatology and Venereology
Congress (EADV), October 2019.
- Langley RG, et al. Efficacy and Safety of Long-Term
Tildrakizumab for Plaque Psoriasis: 4-Year Results from reSURFACE
2. Presented at EADV, October
2019.
- Lebwohl MG, et al. Tildrakizumab Efficacy by Metabolic Syndrome
Status in Psoriasis: Post Hoc Analysis of 3-Year Data from the
Phase 3 reSURFACE 1 Study. Presented at EADV, October 2019.
- Gottlieb AB, et al. Tildrakizumab Efficacy by Metabolic
Syndrome Status in Psoriasis: Post Hoc Analysis of 3-Year Data from
the Phase 3 reSURFACE 2 Study. Presented at EADV, October 2019.
- Gisondi P, et al. Clin Dermatol. 2018;36(1):21-28.
- Jacobi A, et al. Int J Dermatol.
2016;55(3):296-302.
Contacts:
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SOURCE Sun Pharmaceutical Industries Ltd.