Five-Year SIMPONI Data Reported In Treatment Of Signs And Symptoms Of Moderately To Severely Active Rheumatoid Arthritis

    Five-Year SIMPONI Data Reported In Treatment Of Signs And Symptoms Of
              Moderately To Severely Active Rheumatoid Arthritis

Data from Three Pivotal Phase 3 Trials Presented at 2013 EULAR Annual Congress

PR Newswire

MADRID, June 12, 2013

MADRID, June 12, 2013 /PRNewswire/ --Janssen Biotech, Inc. announced today
new five-year data from three pivotal Phase 3 studies evaluating SIMPONI^®
(golimumab) 50 mg administered subcutaneously once every four weeks in the
treatment of moderately to severely active rheumatoid arthritis (RA). The new
findings from open-label, long-term extensions of the pivotal registration
trials are results from the use of SIMPONI in several RA populations. The
populations studied included patients naive to methotrexate, patients with
active disease despite methotrexate (MTX) and patients who had previously
received anti-tumor necrosis factor (anti-TNF) agents. Among patients
continuing treatment with SIMPONI 50 mg in combination with methotrexate or
other disease-modifying antirheumatic drugs (DMARDs) through five years,
between 60 and 85 percent of patients experienced at least a 20 percent
improvement in American College of Rheumatology criteria (ACR 20) at the end
of the treatment period. The findings are being presented at the 2013 European
League Against Rheumatism (EULAR) Annual Congress.

"These five-year data are important and provide rheumatologists insights into
how patients living with a chronic inflammatory disease like rheumatoid
arthritis may respond over time," said Josef Smolen, M.D., Professor and
Chairman, Department of Rheumatology, Medical University of Vienna, Vienna,
Austria and lead study investigator. "Golimumab continues to be an important
therapeutic option for patients living with moderately to severely active
rheumatoid arthritis."

Five-year Safety and Efficacy of Golimumab in Methotrexate-naive Patients with
Rheumatoid Arthritis: Final Study Results of the Phase 3, Randomized,
Placebo-controlled GO-BEFORE Trial
An analysis using observed data from the Phase 3 GOlimumab Before Employing
methotrexate as the First-line Option in the treatment of Rheumatoid arthritis
of Early onset (GO-BEFORE) trial reported findings on signs and symptoms,
disease activity and physical function among patients receiving SIMPONI 50 mg
and methotrexate for the treatment of moderately to severely active RA through
five years. Patients were randomized to receive placebo and methotrexate
(n=160), SIMPONI 100 mg (n=159), SIMPONI 50 mg and methotrexate (n=159) or
SIMPONI 100 mg and methotrexate (n=159). Patients receiving placebo and
methotrexate crossed over to receive SIMPONI and methotrexate at weeks 28 or
52. Of the 637 methotrexate-naive patients initially randomized in the study,
66 percent remained in the trial through five years. After the last patient
completed week 52 and the study became unblinded, patients receiving placebo
and methotrexate were eligible to cross over to receive SIMPONI 50 mg and
methotrexate. Further, methotrexate and corticosteroid use could be adjusted
and a one-time SIMPONI dose increase and decrease was permitted at the
investigator's discretion. The Phase 3 development program evaluated both
SIMPONI 50 mg and 100 mg; however, the SIMPONI 100 mg dose is not approved in
the United States.

Among patients randomized to receive SIMPONI 50 mg in combination with
methotrexate, 85 percent (92/108) of patients achieved an ACR 20 response and
67 percent (72/108) of patients achieved ACR 50 response, defined as at least
a 50 percent improvement in arthritis signs and symptoms, at week 256. The
study also reported patients' disease activity and physical function at five
years as measured by Disease Activity Score (DAS) 28-C-reactive protein (CRP)
and European League Against Rheumatism (EULAR) response, and the Health
Assessment Questionnaire Disability Index (HAQ-DI) score. DAS28 is a measure
of disease activity in patients with RA that is calculated by assessing the
number of tender and swollen joints (among a total of 28), inflammation (CRP),
and the patient's assessment of global health. CRP is a type of protein
produced in the liver and is expressed during episodes of acute inflammation
associated with RA. EULAR good/moderate response and a HAQ-DI score
improvement of at least 0.25 (minimal clinically important difference, as
defined per protocol; based on an eight-point questionnaire where scores range
from "0" [no disability] to "3" [completely disabled]) were observed in 93
percent (99/106) and 74 percent (78/106) of patients randomized to receive
SIMPONI 50 mg with methotrexate, respectively, at week 256.

According to cumulative safety data assessed at week 268 of the study, the
most common adverse events (AEs) included upper respiratory tract infection
(29 percent), nausea (20 percent), bronchitis (17 percent) and increased
alanine aminotransferase (16 percent). Twelve percent of patients experienced
injection site reactions. Through week 268 of the study, 33 percent (204/616)
of patients experienced a serious AE and 18 percent of patients enrolled in
the trial discontinued SIMPONI due to an AE. Overall rates of serious
infections, malignancies and death were 12 percent, 3 percent and 2 percent,
respectively.

Five-year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid
Arthritis Despite Prior Treatment with Methotrexate: Final Study Results of
the Phase 3, Randomized Placebo-controlled GO-FORWARD Trial
An analysis using observed data from the Phase 3 GOlimumab FOR Subjects With
Active RA Despite Methotrexate (GO-FORWARD) trial reported findings on signs
and symptoms, disease activity and physical function among patients receiving
SIMPONI 50 mg and methotrexate for the treatment of moderately to severely
active RA through five years. Patients were randomized to receive placebo and
methotrexate (n=133), SIMPONI 100 mg and placebo (n=89), SIMPONI 50 mg and
methotrexate (n=89) or SIMPONI 100 mg and methotrexate (n=89). Patients
receiving placebo and methotrexate crossed over to receive SIMPONI and
methotrexate at week 16 or 24. Of the 444 patients initially randomized in
the study, 70 percent remained in the trial through five years. After the
last patient completed week 52 and the study became unblinded, methotrexate
and corticosteroid use could be adjusted, and a one-time SIMPONI dose increase
and decrease was permitted at the investigator's discretion. The Phase 3
development program evaluated both SIMPONI 50 mg and 100 mg; however, the
SIMPONI 100 mg dose is not approved in the United States.

Seventy-seven percent (57/74) of patients randomized to receive SIMPONI 50 mg
in combination with methotrexate achieved ACR 20, and 54 percent (40/74) of
patients randomized to receive SIMPONI 50 mg with methotrexate achieved ACR 50
at week 256. The study also evaluated patients' disease activity and physical
function at five years as demonstrated by EULAR response and HAQ-DI score
improvement of at least 0.25, observed in 89 percent (65/73) and 74 percent
(55/74) of patients randomized to receive SIMPONI 50 mg with methotrexate,
respectively.

According to cumulative safety data assessed at week 268 of the study, the
most common AEs included upper respiratory tract infection (33 percent),
nasopharyngitis (17 percent), bronchitis (17 percent), cough (17 percent) and
injection-site reactions (9 percent). After five years, 40 percent (172/434)
of patients experienced a serious AE, and 14 percent of patients discontinued
SIMPONI. The rates of serious infections, malignancies and death were
evaluated at 12 percent, 6 percent and 2 percent, respectively.

Five-year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid
Arthritis Despite Previous Anti-tumor Necrosis Factor Therapy: Final Study
Results of the Phase 3, Randomized, Placebo-controlled GO-AFTER Trial
An analysis using observed data from the Phase 3 GOlimumab After Former
anti-TNF Therapy Evaluated in RA (GO-AFTER) trial reported findings on signs
and symptoms, disease activity and physical function among patients with
moderately to severely active RA previously treated with TNF inhibitors
receiving treatment with SIMPONI 50 mg through five years. Patients were
randomized to receive placebo +/- DMARDs (n=150), SIMPONI 50 mg +/- DMARDs
(n=147) or SIMPONI 100 mg +/- DMARDs (n=148), and those receiving placebo
crossed over to receive SIMPONI 50 mg at week 16 or 24. Of the 461 patients
initially randomized in the study, 40 percent remained in the trial through
five years. After the last patient completed week 24 and the study became
unblinded, a one-time SIMPONI dose increase and decrease was permitted at the
investigator's discretion. The Phase 3 development program evaluated both
SIMPONI 50 mg and 100 mg; however, the SIMPONI 100 mg dose is not approved in
the United States.

After five years, 60 percent (39/65) of patients randomized to receive SIMPONI
50 mg +/- DMARDs and 65 percent (37/57) of patients in the placebo group who
crossed over to receive SIMPONI +/- DMARDs achieved ACR 20. Forty percent
(26/65) of patients randomized to receive SIMPONI 50 mg +/- DMARDs achieved
ACR 50 and 82 percent (53/65) of patients randomized to receive SIMPONI 50 mg
+/- DMARDs achieved EULAR good/moderate response at week 256 of the study.

According to cumulative safety data assessed at week 268 of the study, the
most common AEs were upper respiratory tract infection (27 percent), worsening
of RA (20 percent), sinusitis (17 percent) and nasopharyngitis (17 percent).
After five years, 35 percent (151/431) of patients experienced a serious AE.
Rates of serious infections, malignancies and death were 14 percent, 5 percent
and 2 percent, respectively.

About the Studies
GO-FORWARD, GO-BEFORE and GO-AFTER were randomized, multicenter,
placebo-controlled trials evaluating the safety and efficacy of subcutaneous
SIMPONI as treatment for moderately to severely active RA in multiple patient
populations including those naive to methotrexate (GO-BEFORE), those with
active disease despite methotrexate (GO-FORWARD) and those who had received
previous anti-TNF agents (GO-AFTER). Long-term extensions began at week 24
(GO-AFTER) or week 52 (GO-FORWARD and GO-BEFORE), with the last SIMPONI
injection occurring at week 252. Observed efficacy results and cumulative
safety data are reported through weeks 256 and 268, respectively.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory condition that is
often characterized by symptoms that include pain, stiffness and inflammation,
and in some cases, joint destruction and disability. It is estimated that 1.5
million Americans^1 and more than 23.5 million people worldwide^1 are affected
by the condition, for which there is no cure.

About SIMPONI^® (golimumab)
SIMPONI is a human monoclonal antibodythat targets and neutralizes excess
TNF-alpha, a protein that when overproduced in the body due to chronic
inflammatory diseases can cause inflammation and damage to bones, cartilage
and tissue. SIMPONI is approved in 67 countries, including the United States
where SIMPONI is approved by the United States Food and Drug Administration
(FDA) for the treatment of adults with moderately to severely active
rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic
arthritis alone or with the medicine methotrexate, active ankylosing
spondylitis and moderately to severely active ulcerative colitis. SIMPONI is
available either through the SmartJect^® autoinjector/prefilled pen or a
prefilled syringe as a subcutaneously administered injection. For more
information about SIMPONI visit www.SIMPONI.com.

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product
in the United States. Janssen pharmaceutical companies market SIMPONI ^ in
Canada, Central and South America, the Middle East, Africa and Asia Pacific.

In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution
rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained
co-marketing rights in those countries. In Europe, Russia and Turkey, Janssen
Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough
(Ireland) Company, a subsidiary of Merck & Co., Inc.

The U.S. full prescribing information for SIMPONI can be accessed at the
following link:
http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf

For further information about SIMPONI outside of the United States, please
consult the relevant official product information applicable to that country
location

Important Safety Information
SIMPONI^®  (golimumab) is a prescription medicine. SIMPONI^® can lower your
ability to fight infections. There are reports of serious infections caused by
bacteria, fungi, or viruses that have spread throughout the body, including
tuberculosis (TB) and histoplasmosis. Some of these infections have been
fatal. Your doctor will test you for TB before starting SIMPONI^® and will
monitor you for signs of TB during treatment. Tell your doctor if you have
been in close contact with people with TB. Tell your doctor if you have been
in a region (such as the Ohio and Mississippi River Valleys and the Southwest)
where certain fungal infections like histoplasmosis or coccidioidomycosis are
common.

You should not start SIMPONI^® if you have any kind of infection. Tell your
doctor if you are prone to or have a history of infections or have diabetes,
HIV or a weak immune system. You should also tell your doctor if you are
currently being treated for an infection or if you have or develop any signs
of an infection such as:

·fever, sweat, or chills ·warm, red, or painful skin or sores on
                               your
·muscle aches            body
·cough                    ·diarrhea or stomach pain
·shortness of breath      ·burning when you urinate or urinate more
·blood in phlegm          than normal
·weight loss              ·feel very tired

Unusual cancers have been reported in children and teenage patients taking
TNF-blocker medicines. For children and adults taking TNF blockers, including
SIMPONI^®, the chances for getting lymphoma or other cancers may increase.
Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly
in teenage or young adult males with Crohn's disease or ulcerative colitis who
were taking other TNF blockers with azathioprine or 6-mercaptopurine. You
should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI^® have developed certain kinds of skin
cancer. If any changes in the appearance of your skin or growths on your skin
occur during or after your treatment with SIMPONI^®, tell your doctor.

Tell your doctor about all the medications you take including ORENCIA
(abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab),
or another TNF blocker, or if you are scheduled to or recently received a
vaccine. People taking SIMPONI^® should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are
carriers of this virus and are taking TNF-blocker medicines, such as
SIMPONI^®. Some of these cases have been fatal. Your doctor should do blood
tests before and after you start treatment with SIMPONI^®. Tell your doctor if
you know or think you may be a carrier of hepatitis B virus or if you
experience signs of hepatitis B infection, such as:

·feel very tired           ·clay-colored bowel movements
·dark urine                ·fevers
·skin or eyes look yellow ·chills
·little or no appetite     ·stomach discomfort
·vomiting                  ·skin rash
·muscle aches

Heart failure can occur or get worse in people who use TNF blockers, including
SIMPONI^®. Your doctor will closely monitor you if you have heart failure.
Tell your doctor right away if you get new or worsening symptoms of heart
failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blockers, including SIMPONI^®, can have nervous
system problems such as multiple sclerosis or Guillain-Barre syndrome. Tell
your doctor right away if you have symptoms like vision changes, weakness in
your arms or legs, or numbness or tingling in any part of your body.

Serious liver problems can happen in people using TNF blockers, including
SIMPONI^®. Contact your doctor immediately if you develop symptoms such as
feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or
pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including
SIMPONI^®. If this occurs, your body may not make enough blood cells to help
fight infections or help stop bleeding. Your doctor will check your blood
counts before and during treatment. Tell your doctor if you have signs such as
fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell
your doctor if you have any symptoms such as a rash on your cheeks or other
parts of the body, sensitivity to the sun, new joint or muscle pain, becoming
very tired, chest pain or shortness of breath, swelling of the feet, ankles,
and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red
scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are pregnant, planning to become pregnant or are
breastfeeding or have a baby and were using SIMPONI^® during pregnancy. Tell
your baby's doctor before your baby receives any vaccine because of an
increased risk of infection for up to 6 months after birth.

Tell your doctor if you are allergic to rubber or latex. The needle cover
contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking
SIMPONI^® such as hives, swollen face, breathing trouble, or chest pain. Some
reactions can be serious and life-threatening.

Common side effects of SIMPONI^® include: upper respiratory tract infection,
reaction at site of injection, and viral infections.

Please read the Medication Guide for SIMPONI^® and discuss any questions you
have with your doctor.

The U.S. full prescribing information for SIMPONI^® can be accessed at the
following link: 
http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology,
urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen
Biotech has delivered on the promise of new treatments and ways to improve the
health of individuals with serious disease. Beyond its innovative medicines,
Janssen Biotech is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates and
health care professionals have access to the latest treatment information,
support services and quality care. For more information on Janssen Biotech,
Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson &
Johnson which are dedicated to addressing and solving some of the most
important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, we work together to bring innovative
ideas, products, services and solutions to people throughout the world. Follow
us on Twitter at www.twitter.com/JanssenUS.

References:

^1 World Health Organization. The global burden of disease: 2004 update.
Geneva: WHO Press, 2008.
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
Accessed May 6, 2013.

SOURCE Janssen Biotech, Inc.

Website: http://www.janssenbiotech.com
Contact: Media Contact: Brian Kenney, Office: 215-628-7010, Mobile:
215-620-0111; or Megan Farina, Office: 215-325-6861, Mobile: 610-724-1079;
Investor Contacts: Louise Mehrotra, Johnson & Johnson, Office: 732-524-6491;
or Stan Panasewicz, Johnson & Johnson, Office: 732-524-2524