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Safety profile summary by indication
Rheumatoid arthritis1
Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months.
In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group. This difference in exposure is primarily due to patients on placebo being more likely to withdraw early. In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
The proportion of patients who discontinued treatment due to adverse events during the controlled trials was 4.4% for patients treated with Cimzia and 2.7% for patients treated with placebo.
The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Axial spondyloarthritis1
Cimzia was initially studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial 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-blind period and a 156-week open-label treatment period. Cimzia was subsequently studied in 317 patients with non-radiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006). Cimzia was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open-label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) 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 experience with Cimzia.
Psoriatic arthritis1
Cimzia was studied in 409 patients with psoriatic arthritis in the PsA001 clinical study for up to 4 years which includes 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 psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Plaque psoriasis1
Cimzia was studied in 1,112 patients with psoriasis in controlled and open-label studies for up to 3 years. In the Phase III program, the initial and maintenance periods were followed by a 96-week open-label treatment period (see section 5.1). The long-term safety profile of Cimzia 400mg every 2 weeks and Cimzia 200mg every 2 weeks was generally similar and consistent with previous experience with Cimzia.
During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.5% for Cimzia and 3.7% for placebo.
The proportion of patients who discontinued treatment due to adverse events in the controlled clinical studies was 1.5% for patients treated with Cimzia and 1.4% for patients treated with placebo.
The most common adverse reactions reported through Week 16 belonged to the system organ classes Infections and infestations, reported in 6.1% of patients on Cimzia and 7% of patients on placebo, General disorders and administration site conditions, reported in 4.1% of patients on Cimzia and 2.3% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 3.5% of patients on Cimzia and 2.8% of patients on placebo.
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Long term safety profile
Cimzia has a well-established long term safety profile across Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis and Psoriasis.1
Summary of Adverse Events (AEs) of interest reported for Cimzia-treated patients (all doses) in the combined RCT and OLE periods (RCT+OLE)2
N number for Crohns disease patients (N=2,570; 4,378 PY) is not shown.
n (%) refers to the number of patients with events; zeros indicate that there were no cases.
NMSC includes serious and non-serious cases.
*Including the five appendicitis events confirmed as SIEs during the previous safety update
in RA.
†Before 2007, a positive TB result on the PPD tuberculin skin test varied (from ≥5 to ≥20 mm) according to geographic region. Since 2007, CZP recommendations internationally
mandate all patients with PPD ≥5 mm receive treatment for latent TB infection. There were no patients with axSpA or PsA enrolled prior to 2007.
‡Lymphoma cases include two cases of Hodgkin’s disease, one in RA and one in PSO.
§Worsening psoriasis defined as psoriasis reported as an AE in a patient enrolled in a PSO study; new-onset psoriasis defined as psoriasis in a patient enrolled in a non-PSO study.
¶Includes serious and non-serious deep vein thrombosis and pulmonary embolism events.
AE, adverse event; axSpA, axial spondyloarthritis; CZP, certolizumab pegol; GI,
gastrointestinal; IR, incidence rate (the number of new cases per 100 PY, with the
denominator being the exposure duration up to the first occurrence of a particular AE);
MACE, major adverse cardiovascular events; NMSC, non-melanoma skin cancer; OI,
opportunistic infection; OLE, open-label extension; PPD, purified protein derivative; PsA,
psoriatic arthritis; PSO, psoriasis; PY, patient-years; RA, rheumatoid arthritis; RCT,
randomised controlled trial; SAE, serious adverse event; SIE, serious infectious event; TB, tuberculosis.
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Common adverse reactions
Common* adverse reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed below.
Adverse reactions in clinical trials and postmarketing1
*Common is defined as (≥1/100 to <1/10).
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Because we're in this together...
Report adverse events
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk and hpra.ie/homepage/about-us/report-an-issue.
Adverse events should also be reported to UCB Pharma Ltd Email: UCBCares.UK@ucb.com and UCBCares.IE@ucb.com.
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Date of preparation: May 2021
IE-P-CZ-AS-2100014