Janssen Presents Long Term Phase 3 Efficacy and Safety Data of Sirukumab in Rheumatoid Arthritis Patients Who had an Inadequate Response and/or Who Were Intolerant to Anti-TNFs

Madrid (ots/PRNewswire) -

Sirukumab Phase 3 Data Presented at the Annual European Congress
of Rheumatology (EULAR) 2017 also Show Significant Improvement in
Quality of Life Measures

Janssen-Cilag International NV (Janssen) today announced long-term
results from SIRROUND-T*, a pivotal Phase 3 study that showed
sirukumab improved the signs and symptoms of moderately to severely
active rheumatoid arthritis (RA) through 52 weeks of treatment in
adult patients with an inadequate response and/or intolerance to
anti-tumour necrosis factor (TNF)-alpha treatments.[1] This is a
typically difficult-to-treat population, representative of clinical
practice where up to 40% of RA patients do not respond to
biologics.[2] This study and other data from the SIRROUND clinical
programme will be presented in 11 abstracts accepted for presentation
at the Annual European Congress of Rheumatology (EULAR) 2017 in
Madrid, Spain.

Data from the SIRROUND-T* study showed that more than half of
patients receiving either sirukumab 50 mg or 100 mg achieved at least
a 20% improvement in the signs and symptoms of disease (ACR20) at
week 52 (54.3% sirukumab 50 mg; 59.3% sirukumab 100 mg).[1] Patients
receiving sirukumab also demonstrated clinically meaningful
improvements from baseline through week 52 in quality of life
measures, as demonstrated by the health assessment questionnaire
disability index (HAQ-DI) and the short form-36 (SF-36) health
survey, for patient-reported outcomes in both physical and emotional
well-being.[1]

The incidences of adverse events (AEs) and serious AEs were
comparable between sirukumab 50 mg (79.6% and 14.2%, respectively)
and sirukumab 100 mg (81.3% and 13.2%, respectively).

"The long-term efficacy of sirukumab as shown in the SIRROUND-T
study is encouraging considering the study includes a
difficult-to-treat patient population. More than 60 percent of
patients in the trial had previously received two or more biologics,
including anti-TNFs and treatments with other mechanisms of action.
This is representative of real world clinical practice," commented
Professor Daniel Aletaha, Consultant Rheumatologist and Associate
Professor at the Medical University of Vienna. "Rheumatoid arthritis
can be a very heterogeneous disease and therefore additional
therapeutic options, like sirukumab, are needed."

In a post-hoc analysis from four sirukumab Phase 3 studies**
presented at the congress, investigators reported that treatment with
sirukumab consistently increased levels of haemoglobin in adult
patients with moderately to severely active RA, thus reducing by week
16 the proportion of patients with anaemia, which is common in
rheumatoid arthritis.[3]

Two additional poster presentations evaluated improvements in
Health-Related Quality of Life (HRQoL) compared with an age/gender
matched normal population in patients with RA and an inadequate
response to conventional disease-modifying anti-rheumatic drugs
(DMARDS) and anti-TNFs (SIRROUND-D and SIRROUND-T Phase 3 studies,
respectively). The post-hoc analyses found that treatment with
sirukumab resulted in greater and clinically meaningful improvements
in HRQoL at week 24 compared with patients receiving placebo
(P<0.001), with similar results observed across sirukumab doses (50
mg every 4 weeks and 100 mg every 2 weeks).[4],[5]

An oral presentation of a post-hoc analysis (SIRROUND-D)
highlighted the effect of sirukumab plus methotrexate on circulating
biomarkers and demonstrated that in addition to inhibiting
radiographic progression (bone destruction measured on x-ray images),
treatment with sirukumab strongly inhibited biomarkers of bone and
tissue destruction, and enhanced markers of bone formation.[6]

"The data presented at this year's congress support the profile of
sirukumab in the treatment of moderately to severely active adult
rheumatoid arthritis. While patient outcomes have improved in the
last few decades with the advent of new RA treatments, there are
still many patients whose disease is not effectively managed and
continues to progress. We believe that sirukumab has the potential to
offer an important new alternative treatment for patients," said
Bogdana Coudsy MD, European Medical Affairs Director Immunology,
Janssen EMEA.

*SIRROUND-T: Efficacy and Safety of Sirukumab in Patients with
Active Rheumatoid Arthritis Despite Anti-TNF Therapy[1],[7]

The Phase 3 SIRROUND-T trial is a randomised, double-blind,
placebo-controlled study that included 878 adult patients with an
inadequate response and/or intolerance to anti-TNF-alpha therapy,
more than 39% of whom had prior exposure to non-TNF-alpha biologic
therapies. Patients were randomised evenly to receive sirukumab 50 mg
every 4 weeks or sirukumab 100 mg every 2 weeks or placebo (patients
on placebo were re-randomised at week 24 to receive sirukumab 50 mg
every 4 weeks or 100 mg every 2 weeks). 54.3% of patients receiving
sirukumab 50 mg every 4 weeks and 59.3% receiving sirukumab 100 mg
every 2 weeks, achieved at least a 20% improvement in ACR response
criteria at week 52. Patients receiving sirukumab achieved clinically
meaningful improvements in patient-reported outcomes as measured by
change from baseline in the Health Assessment Questionnaire
Disability Index (HAQ-DI): sirukumab 50 mg -0.36 (standard deviation,
SD=0.57) and sirukumab 100 mg -0.43 (SD=0.57). Short form-36 (SF-36)
summary scores were: sirukumab 50 mg: physical component summary
(PCS)=5.69, mental component score (MCS)=4.65; sirukumab 100 mg
PCS=5.80, MCS=4.85.

The most common AEs were injection-site reactions and alanine
aminotransferase increases. Malignancies occurred in <3% of the
sirukumab 50 mg and 100 mg treated population and major adverse
cardiac events (MACE) occurred in <2% of the sirukumab 50 mg and 100
mg treated population.

**About the SIRROUND Clinical Programme

The Phase 3 clinical programme in patients with active RA includes
five studies investigating subcutaneously administered sirukumab 50
mg every 4 weeks and sirukumab 100 mg every two weeks in combination
with conventional disease-modifying antirheumatic drugs (DMARDs) or
as monotherapy. The comprehensive development programme - the largest
conducted for an anti-IL-6 biologic therapy - involves more than
3,100 patients encompassing the following five studies:

- SIRROUND-D study: patients who had an inadequate response to
DMARDs. This study has completed.
- SIRROUND-T study: patients who had an inadequate response or were
intolerant to anti-TNF-alpha agents. This study has completed and
data was published in The Lancet (http://www.thelancet.com/pdfs/jou
rnals/lancet/PIIS0140-6736(17)30401-4.pdf) in February 2017.
- SIRROUND-H study: patients with an inadequate response or who were
intolerant to MTX or for whom MTX was inappropriate. This study has
completed.
- SIRROUND-M study: Japanese patients who had an inadequate response
to MTX or sulfasalazine. This study has completed.
- SIRROUND-LTE study: a long-term extension study for patients
completing SIRROUND-D and SIRROUND-T. This study is estimated to
complete in 2020.

Sirukumab is not being investigated for the treatment of anaemia.

About Sirukumab

Sirukumab is a fully human monoclonal IgG1 kappa antibody that
selectively blocks circulating IL-6, a naturally occurring protein
that is believed to play a role in autoimmune conditions like RA. It
is not approved as a treatment for rheumatoid arthritis or any other
indication anywhere in the world. Sirukumab is different from other
interleukin (IL)-6 inhibitors currently approved for the treatment of
RA as it targets the IL-6 cytokine, whereas other agents target the
IL-6 receptor.

In December 2011, Janssen and GSK entered into a licensing and
co-development agreement with respect to sirukumab. Under the terms,
Janssen retains exclusive rights to commercialise sirukumab in
Europe, the Middle East, Africa and Asia Pacific, while GSK has
commercialisation rights in North, Central and South America. The
agreement gives both companies the option to investigate sirukumab
for other indications beyond RA. Sirukumab is currently being
evaluated by health authorities in Europe (http://www.janssen.com/jan
ssen-submits-application-seeking-approval-sirukumab-european-union-rh
eumatoid-arthritis), the US and Japan as a subcutaneous therapy for
the treatment of adult patients with moderately to severely active
rheumatoid arthritis.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic, systemic inflammatory condition
that is characterised by pain, joint swelling, stiffness and loss of
function[8]; it can lead to rapid irreversible joint destruction,
permanent disability and increased mortality.[9] It is estimated that
approximately 6.2 million Europeans are affected by the condition,
for which there is no cure.[10]

In clinical studies patient-reported outcomes are measured by a
number of self-assessed tools. The SIRROUND clinical programme
included SF-36 and HAQ-DI. The short-form 36 (SF-36) survey is a
patient-reported health quality assessment which assesses eight
aspects of health ranging from physical limitations to general
perceptions of vitality and mental well-being. As a general health
assessment tool, it is often paired with a disease-specific
assessment tool. The Health Assessment Questionnaire Disability Index
(HAQ-DI) is a questionnaire for the assessment of rheumatoid
arthritis. The questionnaire is a patient-reported outcome (PRO)
which is usually self-administered by the patient.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives by
finding new and better ways to prevent, intercept, treat and cure
disease inspires us. We bring together the best minds and pursue the
most promising science. We are Janssen. We collaborate with the world
for the health of everyone in it. Learn more at www.janssen.com.
Follow us at Twitter.com/JanssenEMEA
(http://Twitter.com/JanssenEMEA).

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding the potential of sirukumab and expectations for its further
development. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialise,
actual results could vary materially from the expectations and
projections of Janssen-Cilag International NV, any of the other
Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development, including
the uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; manufacturing difficulties or
delays; product efficacy or safety concerns resulting in product
recalls or regulatory action; changes to applicable laws and
regulations, including global health care reforms; and trends toward
health care cost containment. A further list and descriptions of
these risks, uncertainties and other factors can be found in Johnson
& Johnson's Annual Report on Form 10-K for the fiscal year ended
January 1, 2017, including under "Item 1A. Risk Factors," its most
recently filed Quarterly Report on Form 10-Q, including under the
caption "Cautionary Note Regarding Forward-Looking Statements," and
the company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
http://www.sec.gov, http://www.jnj.com or on request from Johnson &
Johnson. None of the Janssen Pharmaceutical Companies or Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.

References

1. Aletaha, D., et al. Efficacy and safety of sirukumab in
patients with active rheumatoid arthritis refractory to anti-TNF
therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled,
parallel-group, multinational, phase 3 study. Lancet. 2017 Mar
25;389(10075):1206-1217.

2. Rubbert-Roth, A., Finckh, A. Treatment options in patients with
rheumatoid arthritis failing initial TNF inhibitor therapy: a
critical review. Arthritis Research & Therapy. 2009;11(Suppl1):S1.

3. Loza, M., et al. Sirukumab Treatment Reduces Levels of
Iron-Regulatory Proteins and Ameliorates Inflammation-Associated
Anemia in Rheumatoid Arthritis Patients. Abstract presented at the
Annual European Congress of Rheumatology (EULAR) 2017 in Madrid,
Spain. Abstract number: FRI0243.

4. Strand, V., et al. Sirukumab Leads To Significant And
Clinically Meaningful Improvements In Health-Related Quality Of Life
That Meet Or Exceed Normative Values In Patients With Rheumatoid
Arthritis Refractory To TNF Inhibitors In Post Hoc Analyses Of A
Phase 3 Trial. Abstract presented at the Annual European Congress of
Rheumatology (EULAR) 2017 in Madrid, Spain. Abstract number: SAT0182.

5. Strand, V., et al. Improvements In Health-Related Quality Of
Life With Sirukumab Are Statistically Significant, Clinically
Meaningful, And Meet Or Exceed Normative Values In Rheumatoid
Arthritis Patients With Inadequate Response To Disease-Modifying
Antirheumatic Drugs: Post Hoc Analyses Of A Phase 3 Trial. Abstract
presented at the Annual European Congress of Rheumatology (EULAR)
2017 in Madrid, Spain. Abstract number: FRI0246.

6. Dasgupta, B., et al. The Effect Of Sirukumab Plus Methotrexate
On Circulating Biomarkers Of Joint Destruction In Moderate To Severe
Rheumatoid Arthritis Patients From The SIRROUND-D Phase 3 Study.
Abstract presented at the Annual European Congress of Rheumatology
(EULAR 2017) in Madrid, Spain. Abstract number: OP0103.

7. Tanaka, Y., et al. Efficacy of Sirukumab, an Anti-IL-6 Cytokine
Monoclonal Antibody, Based upon Prior Use of Non-Anti-TNF Biologics
in Patients with Active Rheumatoid Arthritis Despite Anti-TNF
Therapy: Results from a Global Phase 3 Study, Annual Meeting of the
American College of Rheumatology/Association for Rheumatology Health
Professionals Meeting (ACR/ARHP 2016), Abstract 59315.

8. Suresh E. Diagnosis of early rheumatoid arthritis: what the
non-specialist needs to know. Journal of the Royal Society of
Medicine. 2004;97(9):421-424.

9. Kavuncu, V., Evcik, D. Physiotherapy in Rheumatoid Arthritis.
Medscape General Medicine. 2004;6(2):3.

10. World Health Organization. "The Global Burden of Disease: 2004
Update," p. 32. Available at: http://www.who.int/healthinfo/global_bu
rden_disease/GBD_report_2004update_full.pdf. Accessed 08 November
2016.

PHEM/SIR/0517/0006

June 2017

ots Originaltext: Janssen EMEA
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ebone1@its.jnj.com
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