New Head-to-Head Patient Reported Outcomes Data for Orencia ® SC (abatacept)
vs. Humira® (adalimumab) Presented at the 2012 American College of
Rheumatology Annual Scientific Meeting
*Orencia ^ SC Similar to Humira in Demonstrating Clinical Improvements in
Patient Reported Outcomes in Adults with Moderate to Severe Rheumatoid
*Data are from a one-year analysis of AMPLE, the first head-to-head study
in adults with rheumatoid arthritis comparing Orencia ^ SC to Humira each
on a background of methotrexate
PRINCETON, N.J. -- November 12, 2012
Bristol-Myers Squibb Company (NYSE: BMY) today announced new clinical trial
results showing the subcutaneous (SC) formulation of Orencia^® (abatacept) on
a background of methotrexate (MTX) was similar to Humira^® (adalimumab) plus
MTX in demonstrating clinical improvements in Patient Reported Outcomes (PROs)
in adults with moderate to severe rheumatoid arthritis (RA), including patient
pain, patient global assessment, fatigue, physical function and health related
quality of life (HRQoL) that were sustained for one year.
At one year, Orencia ^ SC plus MTX was similar to Humira plus MTX in improving
patient pain (53.0% and 39.2%), improving patient global assessment (46.1% and
41.2%) and decreasing fatigue (-23.2% and -21.4%). A normal physical function
(measured by the Health Assessment Questionnaire Disability Index, HAQ-DI) was
achieved by 60.4% of patients in the Orencia ^ SC treatment group and 57.0% in
the Humira treatment group, and the measure of Health Related Quality of Life
(HRQoL) assessed using SF-36 was also similar between the two groups.
The data comes from analysis of one-year results from AMPLE (Abatacept Versus
Adalimumab Comparison in Biologic-Naive RA Subjects With Background
Methotrexate), an ongoing, investigator-blinded randomized, Phase IIIb,
controlled study comparing the efficacy of Orencia ^ SC vs. Humira on a
background of MTX in adult, biologic naïve patients with moderate to severe
RA. AMPLE is a two year study with a one year efficacy primary endpoint
(non-inferiority for ACR20).
“The AMPLE PRO data provides important information about Orencia and Humira in
combination with MTX in RA,” said Roy Fleischmann, M.D., University of Texas
Southwestern Medical Center, AMPLE study investigator. “By exploring patient
reported outcomes, which are associated with pain, fatigue, disability and
functional loss that can significantly impact a patient’s health-related
quality of life, we have advanced our understanding of an important area of
focus for RA patients.”
About the Study
AMPLE included 646 adult biologic-naïve patients with active moderate to
severe RA and inadequate response to MTX; 318 in the Orencia ^ SC^®
(abatacept) ^ plus MTX group and 328 in the Humira^® plus MTX group. Patients
were stratified by disease activity and randomized to either 125 mg Orencia ^
SC weekly (without an IV load) or 40 mg Humira every other week, both on
background MTX. The primary endpoint was to determine non-inferiority of
Orencia ^ SC plus MTX to Humira plus MTX by a difference in ACR20 response at
12 months. Secondary endpoints included injection site reactions, radiographic
non-progression as assessed using the van der Heijde modified total Sharp
score (mTSS) method, safety and retention.
PROs assessed were patient pain, patient global assessment and fatigue.
Physical function was evaluated with the HAQ-DI. HRQoL was assessed using the
SF-36. The Routine Assessment of Patient Index Data (RAPID3), an index of
three patient reported core dataset measures, was also assessed.
Detailed Study Results
Improvements in all PROs measured in the study were seen at six months and
sustained at one year. Improvements in patient pain (mean % ± SE) at one year
were 53.0% ± 6.13 in the Orencia SC treatment group, and 39.20% ± 6.20 in the
Humira treatment group (estimate of difference: 13.80% [95% CI, -2.53,
30.14]). Improvements were also demonstrated in patient global assessment at
one year (46.10% ± 3.46 with Orencia ^ SC plus MTX and 41.21% ± 3.43 with
Humira plus MTX, estimate of difference: 4.89% [95% CI, -4.37, 14.15]).
At one year, the onset and proportion of patients achieving a HAQ response
indicating a normal physical function (defined as a reduction in HAQ-DI score
≥0.3 units) was similar between the two treatment groups. HAQ-DI score at
baseline (mean ± SD) was 1.49 ± 0.88 in the Orencia SC group and 1.45 ± 0.68
in the Humira group. Change from baseline (mean ± SE) to year 1 in HAQ-DI was
-0.60 ± 0.04, and -0.59 ± 0.03, for Orencia^® (abatacept) SC and Humira^®,
respectively. Similar reductions in fatigue observed at six months were
maintained through year one in both the Orencia ^ SC and Humira treatment
groups, and exceeded the MCID (a change of -10mm) (estimated difference: -2.42
[95% CI, -6.43, 1.59]).
Orencia SC and IV are indicated for reducing signs and symptoms, inducing
major clinical response, inhibiting the progression of structural damage, and
improving physical function in adult patients with moderately to severely
active rheumatoid arthritis. Orencia may be used as monotherapy or
concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than
tumor necrosis factor (TNF) antagonists.
Orencia IV is indicated for reducing signs and symptoms in pediatric patients
six years of age and older with moderately to severely active polyarticular
juvenile idiopathic arthritis. Orencia IV may be used as monotherapy or
concomitantly with methotrexate (MTX). Orencia SC has not been studied in
pediatric patients. Orencia should not be administered concomitantly with TNF
Orencia is not recommended for use concomitantly with other biologic
rheumatoid arthritis (RA) therapy, such as anakinra.
Orencia is intended for use under the guidance of a physician or healthcare
Important Safety Information
Concomitant Use with TNF antagonists: Concurrent therapy with ORENCIA and a
biologic DMARD is not recommended. In controlled clinical trials, adult
patients receiving concomitant intravenous ORENCIA ^ and TNF antagonist
therapy experienced more infections (63%) and serious infections (4.4%)
compared to patients treated with only TNF antagonists (43% and 0.8%,
respectively), without an important enhancement of efficacy.
Hypersensitivity: Less than 1% of adult patients treated with ORENCIA
experienced hypersensitivity reactions, including some cases of anaphylaxis or
anaphylactoid reactions. Other events potentially associated with drug
hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred
in less than 0.9% of patients treated with ORENCIA ^ ® (abatacept) and
generally occurred within 24 hours of infusion. There was 1 case of a
hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n =190).
Appropriate medical support measures for treating hypersensitivity reactions
should be available for immediate use in the event of a reaction.
Infections: Serious infections, including sepsis and pneumonia, have been
reported in patients receiving ORENCIA. Some of these infections have been
fatal. Many of the serious infections have occurred in patients on concomitant
immunosuppressive therapy which in addition to their underlying disease, could
further predispose them to infection. Caution should be exercised in patients
with a history of infection or underlying conditions which may predispose them
to infections. Treatment with ORENCIA should be discontinued if a patient
develops a serious infection. Patients should be screened for tuberculosis,
and viral hepatitis in accordance with published guidelines, and if positive,
treated according to standard medical practice prior to therapy with ORENCIA.
Immunizations: Live vaccines should not be given concurrently with ORENCIA or
within 3 months of its discontinuation as it may blunt the effectiveness of
some immunizations. It is recommended that JIA patients be brought up to date
with all immunizations in agreement with current immunization guidelines prior
to initiating therapy with ORENCIA.
Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD
patients treated with ORENCIA developed adverse events more frequently than
those treated with placebo (97% vs. 88%, respectively). Respiratory disorders
occurred more frequently in patients treated with ORENCIA compared to those on
placebo (43% vs. 24%, respectively), including COPD exacerbations, cough,
rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA
developed a serious adverse event compared to those on placebo (27% vs. 6%),
including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37
patients (3%)]. Use of ORENCIA in patients with RA and COPD should be
undertaken with caution, and such patients monitored for worsening of their
Blood Glucose Testing: ORENCIA for intravenous administration contains
maltose, which may result in falsely elevated blood glucose readings on the
day of infusion when using blood glucose monitors with test strips utilizing
glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ). Consider using
monitors and advising patients to use monitors that do not react with maltose,
such as those based on glucose dehydrogenase nicotine adenine dinucleotide
(GDH-NAD), glucose oxidase, or glucose hexokinase test methods. ^ ORENCIA^®
(abatacept) for subcutaneous administration does not contain maltose;
therefore, patients do not need to alter their glucose monitoring.
Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if
clearly needed. The risk for development of autoimmune diseases in humans
exposed in utero to abatacept has not been determined. Nursing mothers should
be informed of the risk/benefit of continued breast-feeding or discontinuation
of the drug. A pregnancy registry has been established to monitor fetal
outcomes. Healthcare professionals are encouraged to register pregnant
patients exposed to ORENCIA by calling 1-877-311-8972.
Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs. 1.9%
placebo) and malignancies (1.3% ORENCIA vs. 1.1% placebo). In general, adverse
events in pediatric and adolescent patients were similar in frequency and type
to those seen in adult patients.
Malignancies: The overall frequency of malignancies was similar between adult
patients treated with ORENCIA or placebo. However, more cases of lung cancer
were observed in patients treated with ORENCIA (0.2%) than those on placebo
(0%). A higher rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active disease, are
at a higher risk for the development of lymphoma. The potential role of
ORENCIA in the development of malignancies in humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract
infection, nasopharyngitis, and nausea were the most commonly reported adverse
events in the adult RA clinical studies.
For US Full Prescribing Information, click here.
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. The condition is more
common in women than in men, who account for 75% of patients diagnosed with
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.
For more information about Bristol-Myers Squibb, visit www.bms.com, or follow
us on Twitter at http://twitter.com/bmsnews.
Orencia is a registered trademark of Bristol-Myers Squibb Company. All other
trademarks are property of their respective owners.
Bristol-Myers Squibb Company
Ken Dominski, +1 609-252-5251
John Elicker, +1 609-252-4611
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