NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that new results from the Phase 3 Oral
Psoriatic Arthritis TriaL (OPAL) studies, Broaden
and Beyond, will be presented at the 2016 ACR/ARHP Annual Meeting
(November 11-16, Washington, DC). OPAL Broaden and OPAL Beyond evaluated
the efficacy and safety of XELJANZ® (tofacitinib citrate) in
adult patients with active psoriatic arthritis (PsA) who had an
inadequate response (IR) to conventional synthetic disease-modifying
antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors
(TNFis), respectively. Detailed results from OPAL Broaden will be
presented during a plenary session [#2983] for the first time at
ACR/ARHP. Additionally, results from OPAL Beyond will be presented
during a late-breaking abstract poster session [#10L].
Information and Factors That May Affect Future Results”
“Psoriatic arthritis is a chronic condition that can have a significant
and potentially debilitating impact on people with the disease, who
currently have limited treatment options,” said Michael Corbo, Chief
Development Officer, Inflammation & Immunology, Pfizer Global Product
Development. “As the only JAK inhibitor being investigated in psoriatic
arthritis, tofacitinib, if approved, would provide patients and
healthcare professionals the first medicine in a new class to treat this
disease. We continue to progress the OPAL clinical development program
globally and look forward to possible future regulatory filings.”
OPAL Broaden and OPAL Beyond met their primary efficacy endpoints
showing a statistically significant improvement with tofacitinib 5 mg
and 10 mg twice daily (BID) compared to treatment with placebo at three
months as measured by American College of Rheumatology 20 (ACR20)
response (OPAL Broaden: p=0.05 and p<0.0001; OPAL Beyond: p<0.0001,
respectively), and change from baseline in Health Assessment
Questionnaire Disability Index (HAQ-DI) score (OPAL Broaden: p=0.05 and
p<0.001; OPAL Beyond: p<0.0001 and p<0.001, respectively).1a,2a
OPAL Broaden, which was a 12-month duration trial with a three month
placebo-controlled period, evaluated the efficacy and safety of
tofacitinib 5 mg (n=107) and 10 mg (n=104) BID compared to placebo
(n=105) in adult patients with active PsA who had an IR to at least one
csDMARD and who were TNFi-naïve.1b,1c OPAL Broaden included
an active control arm of adalimumab 40 mg (n=106) administered
subcutaneously every two weeks (q2 wk). The study was not designed for
non-inferiority or superiority comparisons between adalimumab and
tofacitinib. OPAL Beyond, a six-month duration trial with a three month
placebo-controlled period, evaluated the efficacy and safety of
tofacitinib 5 mg (n=131) and 10 mg (n=132) BID compared to placebo
(n=131) in adult patients with active PsA who had an IR to at least one
TNFi.2b OPAL Beyond focused exclusively on the TNFi-IR
patient population. In both studies, patients who were initially
randomized to placebo advanced to tofacitinib 5 or 10 mg BID in a
blinded manner at three months.
In OPAL Broaden, 50.5% and 60.6% of patients achieved an ACR20 response
with tofacitinib 5 mg and 10 mg BID, respectively, compared to 33.3% of
patients taking placebo at three months.1d Patients taking
adalimumab 40 mg q2 wk achieved an ACR20 response rate of 51.9%.1d
In OPAL Beyond, 49.6% and 47.0% of patients achieved ACR20 response with
tofacitinib 5 mg and 10 mg BID, respectively, compared to 23.7% of
patients taking placebo at three months.2c In both studies,
changes from baseline in HAQ-DI score were statistically significantly
greater with tofacitinib 5 mg and 10 mg BID compared to placebo at three
“The findings from OPAL Broaden and OPAL Beyond showed that treatment
with tofacitinib improved symptoms and decreased disease activity in
patients with active psoriatic arthritis who do not respond well to
currently available therapies, including DMARDs and TNFis,” said Philip
Mease, M.D., Swedish Medical Center and University of Washington.
“Tofacitinib, if approved, may be an important treatment option for
people with active psoriatic arthritis.”
The most common adverse events (AEs) in OPAL Broaden and OPAL Beyond
over 12 and six months, respectively, were upper respiratory tract
infection, nasopharyngitis and headache.1e,2d In OPAL Broaden
and OPAL Beyond, serious AEs were reported in 3.8% and 6.1% of patients
taking tofacitinib 10 mg BID, and 7.5% and 3.8% of patients taking
tofacitinib 5 mg BID. Among patients who received placebo for the first
three months and then switched to tofacitinib, 5.8% and 3.0% of patients
who went to tofacitinib 5 mg BID and 7.5% and 1.5% of patients who went
to tofacitinib 10 mg BID, at 12 and six months respectively, experienced
serious AEs.1f,2e In OPAL Broaden, serious AEs were reported
in 8.5% of patients taking adalimumab q2 wk.1f Overall safety
findings in these studies were consistent with those observed in the
broader rheumatology clinical development program for tofacitinib.1g,2f
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic inflammatory multisystem disease.3
PsA causes joint pain and stiffness, skin and nail psoriasis, swollen
toes and fingers, persistent painful tendonitis and irreversible joint
damage.4 An estimated three million people in the U.S. and
Europe combined have active PsA.5 Disease prevalence may even
be higher because it is often misdiagnosed or goes undiagnosed
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a
prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is
not currently approved for the treatment of psoriatic arthritis.
Pfizer is committed to advancing the science of JAK inhibition and
enhancing understanding of XELJANZ through a robust clinical development
program. The efficacy and safety profile of XELJANZ has been studied in
approximately 6,300 patients with moderate to severe rheumatoid
arthritis (RA), amounting to more than 21,000 patient-years of drug
exposure in the global clinical development program.8
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate)
extended-release is a prescription medicine called a Janus kinase (JAK)
inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to
severely active rheumatoid arthritis in which methotrexate did not work
well. XELJANZ/XELJANZ XR may be used as a single agent or in combination
with methotrexate (MTX) or other non-biologic disease-modifying
antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination
with biologic DMARDs or potent immunosuppressants, such as azathioprine
and cyclosporine, is not recommended.
It is not known if XELJANZ/XELJANZ XR is safe and effective in people
with hepatitis B or C.
XELJANZ/XELJANZ XR is not for people with severe liver problems.
It is not known if XELJANZ/XELJANZ XR is safe and effective in
Important Safety Information
XELJANZ/XELJANZ XR can lower the ability of the immune system to
fight infections. Some people can have serious infections while taking
XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused
by bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections. Healthcare providers
should test patients for TB before starting XELJANZ/XELJANZ XR, and
monitor them closely for signs and symptoms of TB and other infections
during treatment. People should not start taking XELJANZ/XELJANZ XR if
they have any kind of infection unless their healthcare provider tells
them it is okay.
People may be at a higher risk of developing shingles.
XELJANZ/XELJANZ XR may increase the risk of certain cancers by
changing the way the immune system works. Lymphoma and other cancers,
including skin cancers, can happen in patients taking XELJANZ/XELJANZ
The risks and benefits of treatment should be considered prior to
initiating XELJANZ/XELJANZ XR in patients with chronic or recurrent
infection; who have been exposed to tuberculosis; with a history of a
serious or an opportunistic infection; who have resided or traveled in
areas of endemic tuberculosis or endemic mycoses; or with underlying
conditions that may predispose them to infection.
Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), was observed in clinical studies with XELJANZ.
Use of live vaccines should be avoided concurrently with
XELJANZ/XELJANZ XR. Update immunizations in agreement with current
immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
Some people who have taken XELJANZ with certain other medicines to
prevent kidney transplant rejection have had a problem with certain
white blood cells growing out of control (Epstein Barr
virus-associated post-transplant lymphoproliferative disorder).
Some people taking XELJANZ/XELJANZ XR can get tears in their stomach
or intestines. This happens most often in people who also take
nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or
XELJANZ/XELJANZ XR should be used with caution in patients who may be
at increased risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis), or who have a narrowing within
their digestive tract. Patients should tell their healthcare provider
right away if they have fever and stomach-area pain that does not go
away or a change in bowel habits.
XELJANZ/XELJANZ XR can cause changes in certain lab test results
including low blood cell counts, increases in certain liver tests, and
increases in cholesterol levels. Healthcare providers should do blood
tests before starting patients on XELJANZ/XELJANZ XR and while they
are taking XELJANZ/XELJANZ XR, to check for these side effects. Normal
cholesterol levels are important to good heart health. Healthcare
providers may stop XELJANZ/XELJANZ XR treatment because of changes in
blood cell counts or liver test results.
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment
is not recommended.
Patients should tell their healthcare providers if they plan to become
pregnant or are pregnant.
It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. To
monitor the outcomes of pregnant women exposed to XELJANZ/XELJANZ XR, a
registry has been established. Physicians are encouraged to register
patients and pregnant women are encouraged to register themselves by
Patients should tell their healthcare providers if they plan to
breastfeed or are breastfeeding. Patients and their healthcare
provider should decide if they will take XELJANZ/XELJANZ XR or
breastfeed. They should not do both.
In carriers of the hepatitis B or C virus (viruses that affect the
liver), the virus may become active while using XELJANZ/XELJANZ XR.
Healthcare providers may do blood tests before and during treatment
with XELJANZ/XELJANZ XR.
Common side effects include upper respiratory tract infections (common
cold, sinus infections), headache, diarrhea, and nasal congestion,
sore throat, and runny nose (nasopharyngitis).
Please click the direct link to the full prescribing information for
XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Working together for a healthier world®
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DISCLOSURE NOTICE: The information contained in this release is as of
November 15, 2016. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about XELJANZ
(tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release,
including a potential new indication for XELJANZ for the treatment of
psoriatic arthritis and their potential benefits, that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the uncertainties
inherent in research and development, including, without limitation, the
ability to meet anticipated trial commencement and completion dates and
regulatory submission dates, as well as the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
additional analyses of existing clinical data; uncertainties regarding
the commercial success of XELJANZ and XELJANZ XR; whether and when any
applications for the potential new indication may be filed with
regulatory authorities in any jurisdictions; whether and when regulatory
authorities in any jurisdictions may approve such applications and/or
any other applications that are pending (including the marketing
authorization application currently under review by the European
Medicines Agency for the treatment of patients with moderate to severe
RA who have had an inadequate response or intolerance to methotrexate)
or may be filed for XELJANZ or XELJANZ XR, which will depend on the
assessment by such regulatory authorities of the benefit-risk profile
suggested by the totality of the efficacy and safety information
submitted; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of XELJANZ/XELJANZ XR; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2015 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
1 PJ Mease, S Hall, O FitzGerald, et al. Efficacy and
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or Adalimumab
in Patients with Active Psoriatic Arthritis and an Inadequate
Response to Conventional Synthetic DMARDs: A Randomized,
Placebo-Controlled, Phase 3 Trial.
a. Results. Pg 2. Para 2. Ln 3-6.
b. Background/Purpose. Pg 2. Para 1. Ln 2-3.
c. Methods. Pg 1. Para 2. Ln 4-5.
d. Pg 5. Table 2. Efficacy endpoints at Month 3 and Month 12.
e. Results. Pg 2. Para 2. Ln 8-10.
f. Pg 7. Table 3. Safety summary to Month 12.
g. Conclusion. Pg 2. Para 3. Ln 3-4.
2 DD Gladman, et al. Efficacy and Safety of Tofacitinib,
an Oral Janus Kinase Inhibitor, in Patients with Active Psoriatic
Arthritis and an Inadequate Response to Tumor Necrosis Factor
Inhibitors: OPAL Beyond, a Randomized, Double Blind,
Placebo-Controlled, Phase 3 Trial.
a. Results. Pg 2. Para 2. Ln 3-4.
b. Background/Purpose. Pg 1. Para 1. Ln 2-4.
c. Pg 5. Table 2. Efficacy endpoints at Month 3 and Month 6.
d. Results. Pg 2. Para 2. Ln 8-10.
e. Pg 6. Table 3. Safety summary to Month 6.
f. Conclusion. Pg 2. Para 3. Ln 4-5.
3 Ritchlin CT, Kavanaugh A, Gladman DD, et al. Treatment
recommendations for psoriatic arthritis. Ann Rheum Dis.
4 National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), National Institutes of Health, US
Department of Health and Human Services. Psoriatic arthritis
overview. NIH publication 14–AR-8001. http://www.niams.nih.gov/health_info/Psoriatic_Arthritis/psoriatic-arthritis.pdf.
Published October 2014.
5 Data on File. Decision Resources Group. Table 1-4:
Number of Total Prevalent Cases of Psoriatic Arthritis in the Major
Pharmaceutical Markets, 2013-2023. United States and Europe, 2016.
6 Helliwell P, Coates L, Chandran V, et al. Qualifying
unmet needs and improving standards of care in psoriatic arthritis.
Arthritis Care Res (Hoboken). 2014;66(12):1759-1766. Page
1/Paragraph 1/Introduction/Lines 1-3
7 Van de Kerkhof PCM, Reich K, Kavanaugh A, et al.
Physician perspectives in the management of psoriasis and psoriatic
arthritis: results from the population-based Multinational
Assessment of Psoriasis and Psoriatic Arthritis survey. J Eur Acad
Dermatol Venereol. 2015;29:2002–2010.
8 Pfizer Data on File.