https://mb.cision.com/Public/18595/3873928/a3d5ba21aa488d95_800x800ar.png
** Post hoc analysis showed meaningful efficacy of certolizumab pegol for R=
A patients with high Rheumatoid Factor (RF) levels
------------------------------------------------------------
=C2=B7 A post hoc analysis from the EXXELERATE trial shows that 65.7 percen=
t of certolizumab pegol-treated patients, and 48.3 percent of adalimumab-tr=
eated patients, with rheumatoid arthritis (RA) and high rheumatoid factor (=
RF) levels achieved low disease activity at Week 104^1=C2=A0
=C2=B7 Certolizumab pegol maintained drug concentrations and achieved Low D=
isease Activity regardless of RF levels in patients with established RA unt=
il the end of the study period (w104)^1
=C2=B7 The results are in line with previous analyses from independent stud=
ies that demonstrate the consistent efficacy of certolizumab pegol across t=
he entire RA population, while TNFis with an Fc fragment showed a decline i=
n efficacy in high RF patients.=C2=A0
=C2=B7 In patients with RA and high RF levels, who are at increased risk of=
disease progression, certolizumab pegol has the potential to deliver meani=
ngful outcomes^1
=C2=A0
Brussels (Belgium), 11 November 2023 =E2=80=93 07:00 (CEST) =E2=80=93 UCB, =
a global biopharmaceutical company, will present a post hoc analysis of the=
EXXELERATE trial examining the efficacy of certolizumab pegol and adalimum=
ab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (=
RF) levels. The data are being presented at the American College of Rheumat=
ology (ACR) Convergence 2023 in San Diego, U.S., November 10=E2=80=9315.^1
In the initial EXXELERATE trial comparing the efficacy of certolizumab pego=
l and adalimumab, the primary endpoints of superiority were not met. The po=
st hoc analysis assessed the efficacy of certolizumab pegol, a PEGylated fr=
agment crystalized (Fc)-free tumor necrosis factor inhibitor (TNFi) and ada=
limumab, an Fc-containing TNFi in patients with RA across RF subgroups.^1 P=
atients were randomized 1:1 to certolizumab pegol 200 mg every 2 weeks plus=
methotrexate (MTX) or adalimumab 40 mg every 2 weeks plus MTX. At Week 12,=
patients were classified as responders or non-responders, non-responders w=
ere switched to the other TNFi with possible follow-up to Week 104. The res=
ults of this post hoc analysis showed that for patients in the higher RF qu=
artile (=E2=89=A4Q3: =E2=89=A4203 IU/mL; >Q3: >203 IU/mL; measured by Roche=
Tina-quant^=C2=AE), 65.7 percent of 453 patients treated with certolizumab=
pegol achieved low disease activity at Week 104 and 48.3 percent of 454 pa=
tients treated with adalimumab achieved low disease activity.^1
=E2=80=9CIt is well known that high rheumatoid factor (RF) levels are assoc=
iated with a poor prognosis^2. In addition, high pre-treatment RF levels ma=
y lead to decreased drug concentrations of monoclonal antibodies and potent=
ially lower response to TNFis in patients with rheumatoid arthritis (RA)^1,=
3. The results of this analysis=C2=A0highlight how certolizumab pegol maint=
ained constant blood concentrations and therapeutic responses regardless of=
RF levels,=E2=80=9D said Professor Josef Smolen, Emeritus Professor of Int=
ernal Medicine, Medical University of Vienna, Division of Rheumatology, Vie=
nna, Austria. =E2=80=9CThese data may be of clinical relevance in the conte=
xt of using a personalized medicine approach for patients with RA and high =
RF levels^1.=E2=80=9D
RA is a chronic disease that causes inflammation throughout the body and co=
mmonly presents as joint pain, swelling and deformity, which results in a d=
ecline in physical function and quality of life.^4,5=C2=A0It is estimated t=
hat, as of 2019, more than 18 million people worldwide live with this disea=
se.^6 High RF is associated with a more aggressive and destructive disease =
course, which is often more difficult to treat.^7 One reason for this is th=
e high levels of RF autoantibodies binding with the Fc parts of TNFis to fo=
rm large immune complexes that are then degraded by macrophages, resulting =
in lower bioavailability of the biologic drugs.^8,9
To treat RA when high RF levels are present, American College of Rheumatolo=
gy 2021 guidelines recommend biologic disease-modifying anti-rheumatic drug=
s (bDMARDS), if there is no observed improvement with MTX treatment.^10=C2=
=A0 However, many bDMARDs such as TNFis contain an Fc region that RF antibo=
dies bind to, which can result in a lower clinical efficacy and the need fo=
r additional interventions.^11,12,13 The distinctive, FC-free structure of =
certolizumab pegol could mean RF may not bind to the drug, which may allow =
its concentration to remain stable over time.^14
=E2=80=9CAt UCB, we aspire to achieve long-lasting remission for as many pa=
tients living with rheumatoid arthritis (RA) as possible,=E2=80=9D said Emm=
anuel Caeymaex, Executive Vice President, Immunology Solutions & Head of U.=
S., UCB. =E2=80=9CThe data presented at this year=E2=80=99s ACR Convergence=
demonstrate the benefits of certolizumab pegol, as it continues to deliver=
value for those with high unmet need late into its lifecycle and beyond. W=
e are excited to continue exploring its scientific potential as a personali=
zed solution for RA patients with high levels of rheumatoid factor (RF)^1.=
=E2=80=9D =C2=A0
Abbreviations: ACR: American College of Rheumatology, Fc: fragment crystali=
zed, MTX: methotrexate, RA: rheumatoid arthritis, RF: rheumatoid factor, TN=
Fis: tumor necrosis factor-=CE=B1 inhibitors.=C2=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T: +32.2.559.94.14=C2=A0
Email: antje.witte@ucb.com =C2=A0
Corporate Communications
Laurent Schots=C2=A0
T: +32.2.559.92.64=C2=A0
Email: laurent.schots@ucb.com=C2=A0
Global Communications
Adriaan Snauwaert
T: +32.497.70.23.46
Email: adriaan.snauwaert@ucb.com=C2=A0
Abbreviations: bDMARDS: biologic disease-modifying anti-rheumatic drugs, Fc=
: fragment crystalized, MTX: methotrexate, RA: rheumatoid arthritis, RF: rh=
eumatoid factor, TNFis: tumor necrosis factor-=CE=B1 inhibitors.
=C2=A0
About the EXXELERATE trial methodology and patient population
In patients with RA, high RF levels are considered a poor prognostic factor=
and are associated with higher disease activity, risk of radiographic prog=
ression, and decreased response to TNF inhibitors (TNFis).^7 Recent data su=
ggest that patients with RA and high RF levels may achieve and maintain gre=
ater clinical improvement with TNFis without a crystallizable fragment (Fc)=
compared to TNFis with an Fc.^12 In this post hoc analysis of the EXXELERA=
TE trial, we assessed efficacy outcomes of certolizumab pegol, a PEGylated =
Fc-free TNFi, versus adalimumab (Fc-containing TNFi) in patients with RA an=
d high RF levels.^1
About CIMZIA^=C2=AE (certolizumab pegol) in the EU/EEA^15
In the EU, CIMZIA=C2=AE (certolizumab pegol) in combination with methotrexa=
te (MTX) is indicated for the treatment of moderate to severe active RA in =
adult patients when the response to disease-modifying antirheumatic drugs (=
DMARDs), including MTX, has been inadequate. Certolizumab pegol can be give=
n as monotherapy in case of intolerance to MTX or when continued treatment =
with MTX is inappropriate. Certolizumab pegol in combination with MTX is al=
so indicated for the treatment of severe, active and progressive RA in adul=
ts not previously treated with MTX or other DMARDs. Certolizumab pegol 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 combination with MTX.
Certolizumab pegol, in combination with MTX, is also indicated for the trea=
tment of active psoriatic arthritis in adults when the response to previous=
DMARD therapy has been inadequate. Certolizumab pegol can be given as mono=
therapy in case of intolerance to MTX or when continued treatment with MTX =
is inappropriate.
Certolizumab pegol is also indicated in the EU for the treatment of adult p=
atients 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 =
anti-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.
Certolizumab pegol is also indicated for the treatment of moderate to sever=
e plaque psoriasis in adults who are candidates for systemic therapy.=C2=A0
CIMZIA^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^15
Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. In the placebo-con=
trolled studies, patients receiving Cimzia had an approximately 4 times gre=
ater duration of exposure compared with the placebo group. This difference =
in exposure is primarily due to patients on placebo being more likely to wi=
thdraw early. In addition, Studies RA-I and RA-II had a mandatory withdrawa=
l for non-responders at Week 16, the majority of whom were on placebo.=C2=
=A0
The commonly reported adverse reactions (=E2=89=A51/100 to <1/10) in clinic=
al trials with certolizumab pegol and post-marketing were viral infections =
(includes herpes =C2=A0zoster, papillomavirus, influenza), bacterial infect=
ions (including abscess), rash, headache =C2=A0(including migraine), asthen=
ia, leukopenia (including lymphopenia, neutropenia), eosinophilic disorder,=
pain (any sites), pyrexia, sensory abnormalities, hypertension, =C2=A0prur=
itus (any sites), hepatitis (including hepatic enzyme increase), injection =
site reactions, and nausea.=C2=A0
Certolizumab pegol was initially studied in 325 patients with active axial =
spondyloarthritis (including ankylosing spondylitis and non-radiographic ax=
ial spondyloarthritis) in the AS001 clinical study for up to 4 years, which=
includes a 24-week placebo-controlled phase followed by a 24-week dose-bli=
nd period and a 156-week open-label treatment period. Certolizumab pegol wa=
s subsequently studied in 317 patients with non-radiographic axial spondylo=
arthritis in a placebo-controlled study for 52 weeks (AS0006).=C2=A0
Certolizumab pegol was also studied in patients with axial spondyloarthriti=
s (including ankylosing spondylitis and non-radiographic axial spondyloarth=
ritis) in a clinical study for up to 96 weeks, which included a 48-week ope=
n-label run-in phase (N=3D736) followed by a 48-week placebo-controlled pha=
se (N=3D313) for patients in sustained remission (C-OPTIMISE). Certolizumab=
pegol was also studied in a 96-week open-label study in 89 axSpA patients =
with a history of documented anterior uveitis flares. In all 4 studies, the=
safety profile for these patients was consistent with the safety profile i=
n rheumatoid arthritis and previous experience with certolizumab pegol.
Certolizumab pegol was studied in 409 patients with psoriatic arthritis (Ps=
A) in the PsA001 clinical study for up to 4 years which included a 24-week =
placebo-controlled phase followed by a 24-week dose-blind period and a 168-=
week open-label treatment period. The safety profile for PsA patients treat=
ed with certolizumab pegol was consistent with the safety profile in RA and=
previous experience with certolizumab pegol.=C2=A0
Abbreviations: AS: Ankylosing spondylitis, axSpA: Axial spondyloarthritis, =
CRP: C-reactive protein, DMARDs: disease-modifying antirheumatic drugs, EEA=
: European Economic Area, EU: European Union, MRI: Magnetic Resonance Imagi=
ng, MTX: methotrexate, NSAIDs: non-steroidal anti-inflammatory drugs, RA: r=
heumatoid arthritis, RF: Rheumatoid factor. TNFis: tumor necrosis factor-=
=CE=B1 inhibitors.
Certolizumab pegol was studied in 1112 patients with psoriasis in controlle=
d and open-label studies for up to 3 years. In the Phase III program, the i=
nitial and maintenance periods were followed by a 96-week open-label treatm=
ent period. The long-term safety profile of certolizumab pegol 400 mg every=
2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar =
and consistent with previous experience with certolizumab pegol.
Serious adverse reactions, defined as an adverse reaction that results in d=
eath, is life-threatening, requires hospitalization or prolongation of exis=
ting hospitalization, results in persistent or significant disability or in=
capacity, or is a birth defect, include sepsis, opportunistic infections, t=
uberculosis (including miliary, disseminated and extrapulmonary), herpes zo=
ster, lymphoma, leukemia, solid organ tumors, angioneurotic oedema, cardiom=
yopathies (includes heart failure), ischemic coronary artery disorders, pan=
cytopenia, hypercoagulation (including thrombophlebitis, pulmonary embolism=
), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes ci=
rrhosis), and renal impairment/nephropathy (includes nephritis). In RA cont=
rolled clinical trials, 4.4% of patients discontinued taking certolizumab p=
egol due to adverse events vs. 2.7% for placebo.
Certolizumab pegol is contraindicated in patients with hypersensitivity to =
the active substance or any of the excipients, active tuberculosis or other=
severe infections such as sepsis or opportunistic infections, and moderate=
to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g., histoplasmosis, nocardia, candidiasis) have been reported in pat=
ients receiving certolizumab pegol. Some of these events have been fatal. B=
efore initiation of therapy with certolizumab pegol, all patients must be e=
valuated for both active and inactive (latent) tuberculosis infection. If a=
ctive tuberculosis is diagnosed prior to or during treatment, certolizumab =
pegol therapy must not be initiated and must be discontinued. If latent tub=
erculosis is diagnosed, appropriate anti-tuberculosis therapy must be start=
ed before initiating treatment with certolizumab pegol.=C2=A0
Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including certolizumab pegol who are chronic carriers of the virus (i.=
e., surface antigen positive). Some cases have had a fatal outcome. Patient=
s should be tested for HBV infection before initiating treatment with certo=
lizumab pegol. Carriers of HBV who require treatment with certolizumab pego=
l should be closely monitored and in the case of HBV reactivation Certolizu=
mab pegol should be stopped and effective anti-viral therapy with appropria=
te supportive treatment should be initiated.
TNF antagonists including certolizumab pegol may increase the risk of new o=
nset or exacerbation of clinical symptoms and/or radiographic evidence of d=
emyelinating disease including multiple sclerosis; of formation of antinucl=
ear antibodies and uncommonly of the development of a lupus-like syndrome; =
of severe hypersensitivity reactions. If a patient develops any of these ad=
verse reactions, certolizumab pegol should be discontinued and appropriate =
therapy instituted.
With the current knowledge, a possible risk for the development of lymphoma=
s, leukemia or other malignancies in patients treated with a TNF antagonist=
cannot be excluded. Rare cases of neurological disorders, including seizur=
e disorder, neuritis and peripheral neuropathy, have been reported in patie=
nts treated with certolizumab pegol.
Adverse reactions of the hematologic system, including medically significan=
t cytopenia, have been reported with certolizumab pegol. Advise all patient=
s to seek immediate medical attention if they develop signs and symptoms su=
ggestive of blood dyscrasias or infection (e.g., persistent fever, bruising=
, bleeding, pallor) while on certolizumab pegol. Consider discontinuation o=
f certolizumab pegol therapy in patients with confirmed significant hematol=
ogical abnormalities.
Severe infections and neutropaenia were reported in clinical trials with co=
ncurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28=
modulator) and another TNF-antagonist, etanercept, with no added benefit c=
ompared to TNF-antagonist therapy alone. Because of the nature of the adver=
se events seen with the combination of another TNF-antagonist with either a=
batacept or anakinra therapy, similar toxicities may also result from the c=
ombination of anakinra or abatacept and other TNF-antagonists. Therefore th=
e use of certolizumab pegol in combination with anakinra or abatacept is no=
t recommended.
There is limited safety experience with surgical procedures in patients tre=
ated with Cimzia. The 14-day half-life of certolizumab pegol should be take=
n into consideration if a surgical procedure is planned. A patient who requ=
ires surgery while on Cimzia should be closely monitored for infections, an=
d appropriate actions should be taken. Please consult the full prescribing =
information in relation to other side effects, full safety and prescribing =
information.=C2=A0
European SmPC date of revision April 2023. https://www.ema.europa.eu/en/doc=
uments/product-information/cimzia-epar-product-information_en.pdf. Last acc=
essed: October 2023.
Abbreviations: HBV: hepatitis B, RA: rheumatoid arthritis, RF: rheumatoid f=
actor, TNF: tumor necrosis factor.
About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,700 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follo=
w us on Twitter: @UCB_news.
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=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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References:
1. Smolen J, Taylor P, Tanaka Y, et al. Do High RF Titers Impact Response t=
o TNF Inhibitors? Comparison of Certolizumab Pegol and Adalimumab in Patien=
ts with RA and High Titers of RF: A Post Hoc Analysis of a Phase 4 Trial. A=
rthritis Rheumatol. 2023;75 (suppl 9). ACR Convergence 2023. 2148.
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in rheumatoid arthritis patients: a review of data from randomized clinical=
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(10055):2023=E2=80=9338.=C2=A0
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s. Last accessed: November 2023.=C2=A0
7. van Zeben D, Hazes J, Zwinderman A, et al. Clinical significance of rheu=
matoid factors in early rheumatoid arthritis: results of a follow up study.=
Ann Rheum Dis. 1992;51(9):1029-35.
8. Laurent L, Anquetil F, Clavel C, et al. IgM rheumatoid factor amplifies =
the inflammatory response of macrophages induced by the rheumatoid arthriti=
s-specific immune complexes containing anticitrullinated protein antibodies=
. Ann Rheum Dis. 2015;74(7):1425-31.=C2=A0
9. Aletaha D, Alasti F, Smolen JS. Rheumatoid factor determines structural =
progression of rheumatoid arthritis dependent and independent of disease ac=
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10. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheu=
matology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Car=
e Res (Hoboken). 2021;73(7):924-39.=C2=A0
11. Takeuchi T, Miyasaka N, Inui T, et al. High titers of both rheumatoid f=
actor and anti-CCP antibodies at baseline in patients with rheumatoid arthr=
itis are associated with increased circulating baseline TNF level, low drug=
levels, and reduced clinical responses: a post hoc analysis of the RISING =
study. Arthritis Res Ther. 2017;19(1):194.
12. Nakayama Y, Watanabe R, Murakami K, et al. Differential efficacy of TNF=
inhibitors with or without the immunoglobulin fragment crystallizable (Fc)=
portion in rheumatoid arthritis: the ANSWER cohort study. Rheumatol Int. 2=
022;42(7):1227-34.=C2=A0
13. Calvo Gutierrez J, Ortega Castro R, =C3=81balos-Aguilera MC, et al. Imp=
act of baseline rheumatoid factor titers and anti-TNF molecular structure o=
n the retention rate in patients with rheumatoid arthritis. Ann Rheum Dis. =
2023;82:1400-1.=C2=A0
14. Senolt L. Emerging therapies in rheumatoid arthritis: focus on monoclon=
al antibodies. F1000Res. 2019;8:F1000 Faculty Rev-1549.
15. CIMZIA^=C2=AE (certolizumab pegol) EU SmPC. April 2022. Available at: h=
ttps://www.ema.europa.eu/en/documents/product-information/cimzia-epar-produ=
ct-information_en.pdf. Last accessed: November 2023.
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