ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in Year Two Data from Head-to-Head Study in Patients with Moderate to Severe Rheumatoid Arthritis

Paris (ots/PRNewswire) -

AMPLE Study results highlighted during a press conference at the
European

League Against Rheumatism (EULAR) Annual congress

- Year 2 data shows similar efficacy between ORENCIA plus 
methotrexate (MTX)
  and Humira plus MTX, consistent with the year 1 result which 
demonstrated comparable
  efficacy based on a non-inferiority endpoint for ACR 20 response
- Radiographic non-progression at 2 years was achieved by 85 percent 
of patients
  on ORENCIA plus MTX and 84 percent of patients on Humira plus MTX
- The frequency of adverse events was overall similar in both groups;
there were
  numerically fewer discontinuations due to adverse events, serious 
adverse events,
  serious infections, and fewer local injection site reactions in 
patients treated with
  ORENCIA plus MTX

Bristol-Myers Squibb Company [http://www.bms.com ] today announced
the results of year two data from AMPLE (Abatacept Versus Adalimumab
Comparison in Biologic-Naive rheumatoid arthritis (RA) Subjects With
Background Methotrexate), a first-of-its-kind trial of 646 patients
comparing the subcutaneous (SC) formulation of ORENCIA(R) (abatacept)
vs. Humira(R) (adalimumab), each on a background of MTX, in biologic
naive patients with moderate to severe RA. The AMPLE year two data
were presented today at the European League Against Rheumatism
(EULAR) Annual congress and highlighted during a congress press
conference.

AMPLE met its primary endpoint as measured by non-inferiority of
ACR20 (American College of Rheumatology 20 percent improvement) at
year one. The ORENCIA regimen achieved comparable rates of efficacy
vs. the Humira regimen (64.8% vs. 63.4%, respectively). Onset of
response was also generally similar for the two groups.

Year two of the study remained investigator-blinded. At year two, the
ORENCIA regimen achieved the same rate of efficacy (60%) as the
Humira regimen based on ACR20. ACR50, 70, and 90, considered to be
more stringent measures of efficacy, as well as DAS-28-CRP, were
assessed over 24 months and were generally similar for the two arms.

Radiographic progression was also assessed at two years with 85% of
patients on the ORENCIA regimen and 84% of patients on the Humira
regimen achieving radiographic non-progression.

"Results from the second year of the AMPLE study confirm what we saw
in year one data," said Michael Schiff, M.D., M.A.C.R., University of
Colorado, and principal AMPLE study investigator, "namely, that
efficacy was comparable for the two agents in this study."

At 24 months, overall safety data were similar for both groups,
including frequency of adverse events (92.8% and 91.5%), serious
adverse events (13.8% and 16.5%), and malignancies (2.2% and 2.1%)
for the ORENCIA regimen and the Humira regimen, respectively.
Discontinuations due to adverse events were 3.8% for the ORENCIA
regimen and 9.5% for the Humira regimen, while discontinuations due
to serious adverse events were 1.6% for the ORENCIA regimen and 4.9%
for the Humira regimen. Additionally, zero of the 12 patients who
experienced serious infections in the ORENCIA group discontinued,
while nine of the 19 patients who experienced serious infections in
the Humira group discontinued. Autoimmune events, of mild or moderate
severity, were reported in 3.8% of patients in the ORENCIA group and
1.8% of patients in the Humira group. Injection site reactions were
reported in 4.1% of patients taking the ORENCIA regimen and 10.4% of
patients taking the Humira regimen.

"The 2 year follow-up data from AMPLE provide important information
on the clinical profile of ORENCIA plus MTX as a first biologic
treatment option for patients with severe to moderate RA," said Dr.
Schiff.

Notes to editors

About the AMPLE study[i],[ii]

In addition to and separate from the pivotal trials, the safety and
efficacy of SC abatacept has been shown in the AMPLE study, the first
direct comparison of two biologics on a background of MTX.

Presented at the 2013 European League Against Rheumatism (EULAR)
Annual congress, AMPLE is a 2-year, head-to-head trial of 646
patients comparing the subcutaneous (SC) formulation of abatacept
with adalimumab - an anti-TNF - in a standard of care setting, namely
on a background of methotrexate (MTX) for biologic naive patients
with moderate to severe RA.

The primary endpoint of the study was to determine non-inferiority of
abatacept plus MTX to adalimumab plus MTX based on ACR 20 at 12
months. Secondary endpoints at one and two years included inhibition
of radiographic progression, safety, injection site reactions and
retention.

AMPLE demonstrated that SC abatacept plus MTX achieved comparable
rates of efficacy for the American College of Rheumatology criteria
of 20 percent (ACR20) response at 1 year of 64.8% vs. 63.4% HUMIRA
plus MTX, with similar kinetics of response and inhibition of
radiographic progression at one year. At year two, comparable
efficacy was maintained, with 60% of patients on either abatacept or
adalimumab achieving an ACR20 response. Both agents achieved similar
response rates (ACR20, 50, 70 and 90), disease status scores (DAS
28-CRP, SDAI, CDAI) and levels of radiographic progression
inhibition.

The overall safety data were similar for abatacept and adalimumab,
including incidence of AEs (92.8% vs 91.5%), SAEs (13.8% vs 16.5%)
and malignancies (2.2% vs 2.1%), with some notable exceptions:

- Discontinuations due to AEs were less than half as common with 
abatacept
  compared with adalimumab (3.8% vs 9.5%).
- Discontinuations due to SAEs with abatacept were also less than 
half as common
  compared with adalimumab (1.6% vs 4.9%).
- Autoimmune events were reported in 3.8% of patients in the 
abatacept group and
  1.8% of patients in the adalimumab group. All of these autoimmune 
events were mild or
  moderate in severity and are consistent with those expected in an 
RA population.

In addition, in terms of tolerability, injection-site reactions
occurred less frequently in those treated with abatacept compared
with adalimumab (4.1% vs 10.4%, no discontinuation with abatacept) at
12 months.

The types of AEs and SAEs were consistent with those shown in
previous abatacept or adalimumab studies.

About abatacept

Abatacept is the first RA biologic agent to be available in both an
intravenous (IV) and a self-injectable, subcutaneous (SC)
formulation.[iii],[iv]

Abatacept, in either injectable formulation (IV or SC), is a
treatment designed to reduce the signs and symptoms, reduce the
progression of joint damage and improve physical function in adults
with rheumatoid arthritis (RA). In Europe, it is indicated for use in
combination with methotrexate (MTX) to treat moderate to severe
active RA in adults who have had an inadequate response to a
disease-modifying anti-rheumatic drug (DMARD), including MTX or a
tumour necrosis factor (TNF) antagonist (also known as an anti-TNF).

In addition, abatacept IV is approved for use in children six years
of age and older with polyarticular juvenile idiopathic arthritis
(JIA) who have responded inadequately to other treatments including
at least one anti-TNF agent.

For a full description of abatacept, including efficacy and safety
profile, please consult the Summary of Product Characteristics
(SmPC):

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_In
formation/human/000701/WC500048935.pdf

.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease
characterized by inflammation in the lining of joints (or synovium),
causing joint damage with chronic pain, stiffness, swelling and
fatigue. RA causes limited range of motion and decreased joint
function.

In Europe, more than 2.9 million people are affected by RA,[v] a
condition which can severely impact patients' quality of life and can
lead to increased mortality and morbidity.[vi] The condition is more
common in women, who account for 75% of patients diagnosed with
RA.[vii]

With appropriate treatment, patients can achieve better clinical
outcomes, resulting in more active days and improved
well-being.[viii]

Abatacept is one of the biologic treatment options indicated in adult
patients with moderate to severely active RA for patients who respond
inadequately to previous DMARDs. The approval of the new subcutaneous
formulation in 2012 offers one more option, giving some patients the
opportunity to treat themselves at home.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed
to discovering, developing and delivering innovative medicines that
help patients prevail over serious diseases.

ORENCIA is a registered trademark of Bristol-Myers Squibb Company.
All other trademarks are property of their respective owners.

i. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Abstract
3409)

ii. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Oral
presentation)

iii. Orencia IV SPC. Available from: http://www.medicines.org.uk/emc/
medicine/19714/SPC/ORENCIA+250+mg+powder+for+concentrate+f
or+solution+for+infusion/ [http://www.medicines.org.uk/emc/medicine/
19714/SPC/ORENCIA+250+mg+powder+for+concentrate+for+solution+for+infu
sion ] Last accessed: May 2013

iv. Orencia SC SPC. Available from: http://www.medicines.org.uk/emc/m
edicine/27216/SPC/ORENCIA+125+mg+solution+for+injection+(
pre-filled+syringe)/ [http://www.medicines.org.uk/emc/medicine/27216
/SPC/ORENCIA+125+mg+solution+for+injection+(pre-filled+syringe) ]
Last accessed: May 2013

v. National Rheumatoid Arthritis Foundation Available at: http://www.
nras.org.uk/about_rheumatoid_arthritis/living_with_rheumatoid_arthrit
is/employm ent_benefits/european_fit_for_work_report.aspx Last
accessed 5 September 2012.

vi. March L and Lapsley H. "What are the costs to society and the
potential benefits from the effective management of early rheumatoid
arthritis?" Best Practice & Research Clinical Rheumatology
2001;15(1):171-185.

vii. National Institute of Arthritis and Musculoskeletal and Skin
Diseases. National Institutes of Health. U.S.Department of Health and
Human Services. Rheumatoid Arthritis. May 2004.

viii. American College of Rheumatology. Available at: http://www.rheu
matology.org/practice/clinical/patients/diseases_and_conditions/ra.as
p. Last accessed 5 September 2012.

ORIGINAL APA-OTS TEXT - THE INFORMATION CONTAINED IN THIS PRESS RELEASE IS SUBJECT TO THE EXCLUSIVE RESPONSIBILITY OF THE ISSUER | PRN

print