- In ulcerative colitis patients with a clinical response to
risankizumab induction treatment, a significantly higher proportion
of patients treated with risankizumab (180 mg or 360 mg) achieved
the primary endpoint of clinical remissiona (per Adapted
Mayo Score) at week 52 compared to withdrawal from
risankizumab treatment1
- Key secondary endpoints were met, including endoscopic
improvementb, histologic endoscopic mucosal
improvementc and steroid-free
remissiond at one year
- Safety results in this study were consistent with the known
safety profile of risankizumab, with no new safety risks
observed1
- Building on AbbVie's growing gastroenterology portfolio,
risankizumab is an IL-23 inhibitor being evaluated as a treatment
for adults with moderate to severe ulcerative colitis and approved
for Crohn's disease, psoriatic arthritis and
psoriasis1
NORTH
CHICAGO, Ill., June 15,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced positive top-line results from COMMAND, its Phase 3
maintenance study, showing risankizumab (SKYRIZI®, 180
mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of
clinical remission (per Adapted Mayo Score) at week 52, as well as
key secondary endpoints in adult patients with moderately to
severely active ulcerative colitis.1 In the COMMAND
maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction
treatment were re-randomized to receive risankizumab 180 mg SC, 360
mg SC or withdrawal from risankizumab treatment (risankizumab
intravenous [IV] induction-only control
group).1 Approximately 75% of patients previously
failed at least one advanced therapy (biologics, JAK inhibitors
and/or S1P receptor modulators) for ulcerative
colitis.1
A significantly higher proportion of patients who received
risankizumab 180 mg or 360 mg achieved clinical remission at week
52: 40% and 38%, respectively, compared to 25% in the
induction-only control group (p<0.01).1
"Through important programs such as the Phase 3 COMMAND study,
we continue to drive research and development to help manage the
impact of serious gastroenterological conditions," said
Roopal Thakkar, M.D., senior vice
president, development, regulatory affairs and chief medical
officer, AbbVie. "Risankizumab is already approved in moderately to
severely active Crohn's disease, and these results demonstrate that
this treatment can be a potentially effective option for ulcerative
colitis as well."
In COMMAND, 51% of patients treated with risankizumab 180 mg and
48% of patients treated with risankizumab 360 mg achieved
endoscopic improvement at week 52 vs 32% of patients in the
induction-only control group (p<0.001).1
Additionally, significantly more patients treated with risankizumab
180 mg and 360 mg achieved histologic endoscopic mucosal
improvement at week 52 compared to those treated with
induction only: 43% and 42%, respectively, vs 23%
(p<0.001).1 A significantly higher proportion of
patients who received risankizumab 180 mg or 360 mg achieved
steroid-free clinical remission compared to the induction-only
control group at week 52 (40% and 37%, respectively, vs 25%;
p<0.01).1
"These positive results suggest that risankizumab is a promising
therapy to help ulcerative colitis patients with challenging
symptoms that disrupt their daily lives," said Stefan Schreiber, M.D., director of department
of internal medicine I, University Hospital
Schleswig-Holstein, Germany, COMMAND study investigator.
"Risankizumab's achievement of a broad range of difficult-to-reach
endpoints encompassing endoscopic-histologic outcomes and many
others represents important progress toward addressing the need for
additional treatment options for patients with ulcerative
colitis."
Efficacy Results at
Week 52*,1
|
|
Risankizumab
180 mg SC
(n=179)
|
Risankizumab
360 mg SC
(n=186)
|
Risankizumab
IV
induction only
(control
group)
(n=183)
|
Clinical Remission
(Adapted Mayo Score)a
|
40 %
|
38 %
|
25 %
|
Endoscopic
Improvementb
|
51 %
|
48 %
|
32 %
|
Histologic Endoscopic
Mucosal Improvement (HEMI)c
|
43 %
|
42 %
|
23 %
|
Steroid-free Clinical
Remissiond
|
40 %
|
37 %
|
25 %
|
*Primary endpoint was clinical
remission (per Adapted Mayo Score). Endoscopic improvement,
HEMI and steroid-free clinical remission were secondary
endpoints. Not all secondary endpoints are shown. All primary and
secondary endpoints displayed achieved statistical significance
under the overall Type I error rate of 0.05 (2-sided).
a Clinical remission per Adapted Mayo Score is defined
as stool frequency subscore (SFS)
≤1 and not greater than baseline, rectal bleeding subscore (RBS) of
0 and endoscopic subscore ≤1 without evidence of
friability.
b Endoscopic improvement is defined
as endoscopic subscore ≤1 without evidence of friability.
c HEMI is defined as an endoscopic subscore of ≤1
without evidence of friability and Geboes score ≤3.1.
d Steroid-free remission is defined as clinical
remission per Adapted Mayo score at week 52 and corticosteroid free
for ≥90 days prior to week 52.
|
The safety profile of risankizumab in the 52-week, double-blind,
placebo-controlled COMMAND study was consistent with the safety
profile observed in previous studies across other indications, with
no new safety risks observed.1 The most common adverse
events observed in the risankizumab groups were colitis ulcerative,
COVID-19, nasopharyngitis and arthralgia.1 Serious
adverse events occurred in 5.2% and 5.1% of patients in the
risankizumab 180 mg and 360 mg groups compared to 8.2% of patients
in the control group.1 There was one death in the
360 mg group due to adenocarcinoma assessed as unrelated to study
drug. There were no adjudicated major adverse cardiac events
(MACE) and no adjudicated anaphylactic reaction events.
Full results from the COMMAND study will be presented at a
future medical meeting and submitted for publication in a
peer-reviewed journal. Use of risankizumab in ulcerative
colitis is not approved and its safety and efficacy have not been
evaluated by regulatory authorities.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated
inflammatory bowel disease (IBD) of the large intestine that causes
continuous mucosal inflammation extending, to a variable extent,
from the rectum to the more proximal colon.2,3 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.3,4 The
disease course of ulcerative colitis varies between patients and
can range from quiescent disease to chronic refractory disease,
which in some cases can lead to surgery or complications, including
cancer or death.4,5 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.6
About COMMAND1
The COMMAND study is a Phase 3, multicenter, randomized,
double-blind, controlled, 52-week maintenance study designed to
evaluate the efficacy and safety of risankizumab 180 mg or 360 mg
SC in adults with moderately to severely active ulcerative colitis.
This study had a re-randomized withdrawal design in which all
patients received risankizumab IV induction and those who responded
to risankizumab were re-randomized to receive risankizumab 180 mg
or 360 mg SC or withdrawal from risankizumab treatment
(induction-only control group). For those randomized to the
withdrawal from risankizumab treatment (induction-only control
group), the rest of the study duration was a risankizumab washout.
The objective of the Phase 3 study is to evaluate the efficacy and
safety of risankizumab 180 mg or 360 mg as maintenance therapy
versus withdrawal from risankizumab treatment (control) in patients
with moderately to severely active ulcerative colitis who responded
to risankizumab IV induction in the INSPIRE study.
The primary endpoint is clinical remission (per Adapted Mayo
Score, defined as SFS ≤1 and not greater than baseline, RBS of 0
and endoscopic subscore ≤1 without evidence of friability) at week
52. Secondary endpoints include endoscopic improvement (endoscopic
subscore ≤1 without evidence of friability), HEMI (endoscopic
subscore of ≤1 without evidence of friability and Geboes score
≤3.1), and steroid-free clinical remission (defined as clinical
remission per Adapted Mayo Score at week 52 and corticosteroid free
for ≥90 days prior to week 52) at week 52. More information can be
found on www.clinicaltrials.gov (NCT03398135).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.7 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases.8
SKYRIZI is approved by the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency for the treatment of plaque
psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials
of risankizumab in psoriasis, psoriatic arthritis, Crohn's
disease and ulcerative colitis are ongoing.8,9,10
U.S. Indications and Important Safety Information about
SKYRIZI® (risankizumab-rzaa)11
SKYRIZI is a prescription medicine used to treat adults
with:
- moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious
side effects, including:
Serious allergic reactions:
- Stop using SKYRIZI and get emergency medical help right away if
you get any of the following symptoms of a serious allergic
reaction:
- fainting, dizziness, feeling lightheaded
(low blood pressure)
- swelling of your face, eyelids, lips,
mouth, tongue, or throat
- trouble breathing or throat
tightness
- chest tightness
- skin rash, hives
- itching
Infections:
SKYRIZI may lower the ability of your
immune system to fight infections and may increase your risk of
infections. Your healthcare provider should check you for
infections and tuberculosis (TB) before starting treatment with
SKYRIZI and may treat you for TB before you begin treatment with
SKYRIZI if you have a history of TB or have active TB. Your
healthcare provider should watch you closely for signs and symptoms
of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
– fever, sweats, or chills
– cough
– shortness of breath
– blood in your mucus (phlegm)
– muscle aches
– warm, red, or painful skin or sores on
your body different from your psoriasis
– weight loss
– diarrhea or stomach pain
– burning when you urinate or urinating
more often than normal
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI. See the
Medication Guide or Consumer Brief Summary for a complete list of
ingredients.
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions,
including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medicines that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
- become pregnant while taking SKYRIZI. You are encouraged to
enroll in the Pregnancy Registry, which is used to collect
information about the health of you and your baby. Talk to your
healthcare provider or call 1-877-302-2161 to enroll in this
registry.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most
important information I should know about SKYRIZI?"
Liver problems in Crohn's disease: A person with Crohn's
disease who received SKYRIZI through a vein in the arm developed
changes in liver blood tests with a rash that led to
hospitalization. Your healthcare provider will do blood tests to
check your liver before, during, and up to 12 weeks of treatment
and may stop treatment with SKYRIZI if you develop liver problems.
Tell your healthcare provider right away if you notice any of the
following symptoms: unexplained rash, nausea, vomiting, stomach
(abdominal) pain, tiredness (fatigue), loss of appetite, yellowing
of the skin and eyes (jaundice), and dark urine.
The most common side effects of SKYRIZI in people treated for
Crohn's disease include: upper respiratory infections,
headache, joint pain, stomach (abdominal) pain, injection site
reactions, low red blood cells (anemia), fever, back pain, and
urinary tract infection.
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis include: upper
respiratory infections, headache, feeling tired, injection site
reactions, and fungal skin infections.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a
600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or
360 mg/2.4 mL single-dose prefilled cartridge with on-body
injector.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for Full Prescribing
Information and Medication
Guide for SKYRIZI.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to
cutting-edge research to drive exciting developments in
inflammatory bowel diseases (IBD), like ulcerative colitis and
Crohn's disease. By innovating, learning and adapting, AbbVie
aspires to eliminate the burden of IBD and make a positive
long-term impact on the lives of people with IBD. For more
information on AbbVie in gastroenterology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie
on Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions and uses
of future or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2022 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
References:
- AbbVie. Data on File: ABVRRTI76012
- Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive
review and update on ulcerative colitis. Dis Mon.
2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
- The facts about inflammatory bowel diseases. Crohn's &
Colitis Foundation of America. Accessed March 8, 2023.
https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Ulcerative colitis. Mayo Clinic. Accessed March 3,
2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
- Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and
prognosis in ulcerative colitis: results from population-based and
observational studies. Ann Gastroenterol.
2014;27(2):95-104.
- Mehta F. Report: economic implications of inflammatory bowel
disease and its management. Am J Manag Care. 2016;22(3
Suppl):s51-60.
- Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC.
Interleukin-23: a key cytokine in inflammatory
diseases. Ann Med. 2011;43(7):503-11.
doi:10.3109/07853890.2011.577093
- Pipeline. AbbVie. Accessed March
3,
2023. https://www.abbvie.com/our-science/pipeline.html
- A study comparing risankizumab to placebo in participants with
active psoriatic arthritis including those who have a history of
inadequate response or intolerance to biologic therapy(ies)
(KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed March 3,
2023. https://clinicaltrials.gov/ct2/show/NCT03671148
- A multicenter, randomized, double-blind, placebo
controlled induction study to evaluate the efficacy and safety of
risankizumab in participants with moderately to severely active
ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023. Accessed March 12, 2023.
https://clinicaltrials.gov/ct2/show/record/NCT03398148
- SKYRIZI [package insert]. North
Chicago, IL: AbbVie Inc.; 2022.
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