https://mb.cision.com/Public/18595/3309578/b994f540ea69c96c_800x800ar.jpg
** UCB Gains CE Mark for ava Connect^=C2=AE, a first-in-class electromechan=
ical device for use with biologic treatment in rheumatology and dermatology
------------------------------------------------------------
ava Connect^=C2=AE is designed to help improve the patient experience and m=
edication adherence for CIMZIA^=C2=AE (certolizumab pegol) by providing a c=
omfortable injection and recording the patient=E2=80=99s injection administ=
ration, visualized on the CimplyMe^=C2=AE companion app
Brussels, Belgium =E2=80=93 March 19, 2021 =E2=80=93 UCB, a global biopharm=
aceutical company, today announced that its first-in-class electromechanica=
l injection device, ava Connect^=C2=AE, has received its Declaration of Con=
formity (CE) Mark.^1=C2=A0The CE Mark indicates conformity with health, saf=
ety, and environmental protection standards for products sold within the Eu=
ropean Economic Area (EEA).^2=C2=A0
The ava Connect^=C2=AE and disposable dose-dispenser cartridge are used for=
self-injecting CIMZIA^=C2=AE (certolizumab pegol), an anti-TNF therapy use=
d to treat adults with rheumatoid arthritis, axial spondyloarthritis, psori=
atic arthritis, and psoriasis (see About CIMZIA section below for complete =
indication information). It is the first reusable device of its kind availa=
ble for use with biologic treatment in rheumatology and dermatology in Euro=
pe.^3=C2=A0To accompany ava Connect^=C2=AE and further support patients, UC=
B has also developed CimplyMe^=C2=AE, a companion mobile application. Both =
are part of UCB=E2=80=99s mission to transform the way patient support is d=
elivered and accelerate better outcomes for people living with severe disea=
ses as part of its digital business transformation.
=E2=80=9CAt UCB, we are increasing our ability to provide differentiating p=
atient value with advanced technology solutions. With the recent accelerati=
on of telemedicine, ava Connect^=C2=AE and CimplyMe^=C2=AE can help improve=
the patient experience and help to make it easier to connect with healthca=
re providers outside of face-to-face consultations by providing symptom and=
treatment adherence monitoring reports. With these technological innovatio=
ns, UCB aims to be a pioneer in digital medicine for rheumatology and derma=
tology patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President,=
Immunology Solutions and Head of US, UCB.=C2=A0
The ava Connect^=C2=AE e-device has been developed together with patients t=
o address injection and treatment management challenges that can lead to lo=
w persistency.^4,5=C2=A0Up to 68 percent of self-injecting patients are non=
-compliant at one year of treatment, resulting in increased healthcare reso=
urce utilization (e.g. hospitalizations, inpatient visits, treatment cost, =
etc.) due to suboptimal treatment outcomes.^6=C2=A0This observation is base=
d on 19 studies reporting compliance data covering rheumatoid arthritis and=
Crohn=E2=80=99s disease patients treated with infliximab, adalimumab, goli=
mumab and etanercept.
The device has a hidden needle and non-slip hand grip to assist patients wi=
th dexterity issues. The large start/pause button and injection speed choic=
e give patients control over their injections. The information screen allow=
s patients to access step-by-step instructions, confirms injection completi=
on and provides injection date notifications.^7=C2=A0Studies have demonstra=
ted that patients find the e-device easy to use and are satisfied with thei=
r self-injection experience.^8
The ava Connect^=C2=AE e-device also logs injection dates, allowing it to r=
ecord objectively patient adherence, which can be shared with clinicians. S=
kin sensors automatically stop an injection if skin contact is lost and the=
needle is retracted within the device. After re-positioning, the injection=
can continue, preventing medication waste and helping to ensure the patien=
t receives the full dose. Safety features ensure that the medication cartri=
dge is automatically checked for drug identity, expiry status, and use stat=
us before an injection is given.^7=C2=A0
CimplyMe^=C2=AE, the companion mobile application for ava Connect^=C2=AE, e=
nables a treatment experience for patients that takes a holistic approach t=
o chronic disease management. By using CimplyMe^=C2=AE with ava Connect^=C2=
=AE, patients will be able to access their injection data, disease manageme=
nt and treatment information, and track and monitor their disease symptoms,=
as well as receive injection reminders. The ava Connect^=C2=AE device can =
be paired with CimplyMe^=C2=AE via a smartphone Bluetooth.
CimplyMe^=C2=AE can create reports that patients can share with their healt=
hcare providers, aiming to support patients to have more efficient consulta=
tions and informed treatment decisions with their healthcare providers guid=
ed by the health metrics and objective injection log.=C2=A0
The ava Connect^=C2=AE e-device is part of a portfolio of CIMZIA self-injec=
tion devices that includes the CIMZIA^=C2=AE pre-filled syringe and the Aut=
oClicks^=C2=AE pre-filled pen. The portfolio aims to provide to HCPs and pa=
tients the choice to identify together the right device for the unmet patie=
nt needs and hence to help improve patient self-injection experience, help =
increase adherence and potentially improve clinical outcomes. UCB continued=
its partnership with OXO, a company known for thoughtful, consumer friendl=
y designs, to develop the ava Connect^=C2=AE e-device.
About OXO
Founded in 1990 on the concept of inclusive universal design, OXO creates h=
ousehold products that make everyday task and chores better. The OXO portfo=
lio spans several categories: cooking, baking, cleaning, storage and organi=
zation, coffee and baby. OXO is available in 90 countries worldwide; its ic=
onic products are included in the permanent collections of numerous museums=
, including the Museum of Modern Art and the Smithsonian Cooper Hewitt Nati=
onal Design Museum. The brand has won over 100 design awards worldwide.
OXO and Good Grips^=C2=AE are trademarks owned and/or licensed by Helen of =
Troy Limited (NASDAQ, NM: HELE), and are used by UCB under license.
About CIMZIA^=C2=AE in the EU/EEA
In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate=
d for the treatment of moderate to severe active RA in adult patients inade=
quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu=
ding MTX.=C2=A0
CIMZIA can be given as monotherapy in case of intolerance to MTX or when co=
ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX=
is also indicated for the treatment of severe, active and progressive RA i=
n adults not previously treated with MTX or other DMARDs.
CIMZIA has been shown to reduce the rate of progression of joint damage as =
measured by X-ray and to improve physical function, when given in combinati=
on with MTX.
CIMZIA, in combination with MTX, is also indicated for the treatment of act=
ive psoriatic arthritis in adults when the response to previous DMARD thera=
py has been inadequate. CIMZIA can be given as monotherapy in case of intol=
erance to MTX or when continued treatment with MTX is inappropriate.
CIMZIA is also indicated in the EU for the treatment of adult patients with=
severe active axial spondyloarthritis (axSpA), comprising:=C2=A0
=C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w=
ho have had an inadequate response to, or are intolerant to non-steroidal a=
nti-inflammatory drugs (NSAIDs).=C2=A0
=C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS =
=E2=80=93 adults with severe active axSpA without radiographic evidence of =
AS but with objective signs of inflammation by elevated C-reactive protein =
(CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re=
sponse to or are intolerant to NSAIDs.
CIMZIA is also indicated for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.=C2=A0
Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information=C2=
=A0
Date of revision March 2021
Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. The commonly repor=
ted adverse reactions (1-10%) in clinical trials with Cimzia^=C2=AE and pos=
t-marketing were viral infections (includes herpes zoster, papillomavirus, =
influenza), bacterial infections (including abscess), rash, headache (inclu=
ding migraine), asthenia, leukopenia (including lymphopenia, neutropenia), =
eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hy=
pertension, pruritus (any sites), hepatitis (including hepatic enzyme incre=
ase), injection site reactions, and nausea. Serious adverse reactions inclu=
de sepsis, opportunistic infections, tuberculosis (including miliary, disse=
minated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid orga=
n tumours, angioneurotic oedema, cardiomyopathies (includes heart failure),=
ischemic coronary artery disorders, pancytopenia, hypercoagulation (includ=
ing thrombophlebitis, pulmonary embolism), cerebrovascular accident, vascul=
itis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/neph=
ropathy (includes nephritis). In RA controlled clinical trials, 4.4% of pat=
ients discontinued taking Cimzia=C2=AE due to adverse events vs. 2.7% for p=
lacebo.=C2=A0
Cimzia was initially studied in 325 patients with active axial spondyloarth=
ritis (including ankylosing spondylitis and non-radiographic axial spondylo=
arthritis) in the AS001 clinical study for up to 4 years, which includes a =
24-week placebo-controlled phase followed by a 24-week dose-blind period an=
d a 156-week open-label treatment period. Cimzia was subsequently studied i=
n 317 patients with non-radiographic axial spondyloarthritis in a placebo-c=
ontrolled study for 52 weeks (AS0006). Cimzia was also studied in patients =
with axial spondyloarthritis (including ankylosing spondylitis and non-radi=
ographic axial spondyloarthritis) in a clinical study for up to 96 weeks, w=
hich included a 48-week open-label run-in phase (N=3D736) followed by a 48-=
week placebo-controlled phase (N=3D313) for patients in sustained remission=
(C-OPTIMISE). In all 3 studies, the safety profile for these patients was =
consistent with the safety profile in rheumatoid arthritis and previous exp=
erience with Cimzia.=C2=A0
Cimzia=C2=AE was studied in 409 patients with psoriatic arthritis (PsA) in =
a clinical study for up to 4 years which included a 24-week placebo-control=
led phase followed by a 24-week dose-blind period and a 168-week open-label=
treatment period.=C2=A0
The safety profile for axSpA and PsA patients treated with Cimzia^=C2=AE wa=
s consistent with the safety profile in RA and previous experience with Cim=
zia=C2=AE.=C2=A0
Cimzia^=C2=AE was studied in 1112 patients with psoriasis in controlled and=
open-label studies for up to 3 years. In the Phase III program, the initia=
l and maintenance periods were followed by a 96-week open-label treatment p=
eriod. The long-term safety profile of Cimzia=C2=AE 400 mg every 2 weeks an=
d Cimzia^=C2=AE 200 mg every 2 weeks was generally similar and consistent w=
ith previous experience with Cimzia.=C2=A0
*EU/EEA means European Union/European Economic Area
Cimzia^=C2=AE is contraindicated in patients with hypersensitivity to the a=
ctive substance or any of the excipients, active tuberculosis or other seve=
re infections such as sepsis or opportunistic infections, and moderate to s=
evere heart failure.=C2=A0Serious infections including sepsis, tuberculosis=
and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) =
have been reported in patients receiving Cimzia^=C2=AE. Some of these event=
s have been fatal. Before initiation of therapy with Cimzia^=C2=AE, all pat=
ients must be evaluated for both active and inactive (latent) tuberculosis =
infection. If active tuberculosis is diagnosed prior to or during treatment=
, Cimzia^=C2=AE therapy must not be initiated and must be discontinued. If =
latent tuberculosis is diagnosed, appropriate anti- tuberculosis therapy mu=
st be started before initiating treatment with Cimzia^=C2=AE.=C2=A0
Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including Cimzia^=C2=AE who are chronic carriers of the virus (i.e. su=
rface antigen positive). Some cases have had a fatal outcome. Patients shou=
ld be tested for HBV infection before initiating treatment with Cimzia^=C2=
=AE. Carriers of HBV who require treatment with Cimzia^=C2=AE should be clo=
sely monitored and in the case of HBV reactivation Cimzia^=C2=AE should be =
stopped and effective anti-viral therapy with appropriate supportive treatm=
ent should be initiated.=C2=A0
TNF antagonists including Cimzia^=C2=AE may increase the risk of new onset =
or exacerbation of clinical symptoms and/or radiographic evidence of demyel=
inating disease including multiple sclerosis; of formation of autoantibodie=
s and uncommonly of the development of a lupus-like syndrome; of severe hyp=
ersensitivity reactions. If a patient develops any of these adverse reactio=
ns, Cimzia^=C2=AE should be discontinued and appropriate therapy instituted=
.=C2=A0
With the current knowledge, a possible risk for the development of lymphoma=
s, leukaemia or other malignancies in patients treated with a TNF antagonis=
t cannot be excluded. Rare cases of neurological disorders, including seizu=
re disorder, neuritis and peripheral neuropathy, have been reported in pati=
ents treated with Cimzia^=C2=AE.=C2=A0
Adverse reactions of the haematologic system, including medically significa=
nt cytopenia, have been reported with Cimzia=C2=AE. Advise all patients to =
seek immediate medical attention if they develop signs and symptoms suggest=
ive of blood dyscrasias or infection (e.g., persistent fever, bruising, ble=
eding, pallor) while on Cimzia^=C2=AE. Consider discontinuation of Cimzia^=
=C2=AE therapy in patients with confirmed significant haematological abnorm=
alities.=C2=A0
The use of Cimzia^=C2=AE in combination with anakinra or abatacept is not r=
ecommended due to a potential increased risk of serious infections. As no d=
ata are available, Cimzia=C2=AE should not be administered concurrently wit=
h live vaccines. The 14-day half-life of Cimzia^=C2=AE should be taken into=
consideration if a surgical procedure is planned. A patient who requires s=
urgery while on Cimzia=C2=AE should be closely monitored for infections.=C2=
=A0
Please consult the full prescribing information in relation to other side e=
ffects, full safety and prescribing information.=C2=A0European SmPC date of=
revision March 2021.=C2=A0
https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-prod=
uct-information_en.pdf
Last accessed: March 2021.
References:
1. UCB Pharma Data on File. ava Connect CE Declaration of Conformity. Febru=
ary 2021.
2. European Commission. CE marking. Available from: https://ec.europa.eu/gr=
owth/single-market/ce-marking_en. Last accessed: January 2021.
3. UCB Pharma Data on File. CIMZIA^=C2=AE AutoClicks^=C2=AE =E2=80=93 Pre-F=
illed Pen Comparison. January 2021.
4. van den Bemt B, Gettings L, Doma=C5=84ska B, et al. A portfolio of biolo=
gic self-injection devices in rheumatology: how patient involvement in devi=
ce design can improve treatment experience. Drug deliv. 2019;26(1):384=E2=
=80=93392.=C2=A0
5. Doma=C5=84ska B, Stumpp O, Poon S, et al. Using Patient Feedback to Opti=
mize the Design of a Certolizumab Pegol Electromechanical Self-Injection De=
vice: Insights from Human Factors Studies. Adv Ther. 2018;35(1):100-115.
6. Maniadakis N, Toth E, Schiff M, et al. A Targeted Literature Review Exam=
ining Biologic Therapy Compliance and Persistence in Chronic Inflammatory D=
iseases to Identify the Associated Unmet Needs, Driving Factors, and Conseq=
uences. Adv Ther. 2018;35(9):1333=E2=80=931355.
7. UCB Pharma Data on File. Cimzia=C2=AE ava=C2=AE BLE - User Manual - UK M=
arket. July 2020.
8. Pouls B, Kristensen L, Petersson M, et al. A pilot study examining patie=
nt preference and satisfaction for ava^=C2=AE, a reusable electronic inject=
ion device to administer certolizumab pegol. Expert Opin Drug Deliv. 2020;1=
7(5):705-711.
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