Evidence map›Paper›PMID 24092417›Full record

ReviewAnnals of the rheumatic diseases2015

Update on the safety profile of certolizumab pegol in rheumatoid arthritis: an integrated analysis from clinical trials.

V P Bykerk, J Cush, K Winthrop, L Calabrese, O Lortholary, M de Longueville, R van Vollenhoven, X Mariette

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.The Cochrane database of systematic reviews · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

V P BykerkHospital for Special Surgery, New York, New York, USA.
J CushBaylor Research Institute and Baylor University Medical Center, Dallas, Texas, USA.
K WinthropOregan Health and Science University, Portland, Oregon, USA.
L CalabreseDepartment of Rheumatologic and Immunologic Disease, Cleveland Clinic, Cleveland, Ohio, USA.
O LortholaryIHU Imagine, Université Paris Descartes, Hôpital Necker Enfants malades, Paris, France.
M de LonguevilleUCB Pharma SA, Brussels, Belgium.
R van VollenhovenDepartment of Rheumatology, Karolinska Institute, Stockholm, Sweden.
X MarietteUniversité Paris-Sud, AP-HP, Hôpitaux universitaires Paris-Sud, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo report the long-term safety data of certolizumab pegol (CZP) in rheumatoid arthritis (RA) accumulated as of 30 November 2011.

designData from 10 completed randomised controlled trials (RCT) of CZP in RA and several open-label extensions (OLE) were pooled across all doses. Reported adverse events (AE) occurred between the first dose and 84 days after the last dose. All deaths, serious infectious events (SIE) and malignancies were reviewed by external experts, classified according to predefined rules, and validated by an external steering committee. Incidence rates (IR) and event rates (ER) per 100 patient-years (PY) are presented.

results4049 RA patients who received CZP were included in the safety pooling; total exposure 9277 PY, mean exposure 2.1 years (range 0.04-7.6). SIE, most frequently pneumonia (IR 0.73/100 PY), were the most common serious AE, occurring more frequently in CZP compared to placebo-treated patients in RCT (IR 5.61/100 PY vs 1.35/100 PY, odds ratio (OR) 4.35, 95% CI 0.65 to 29.30). SIE rates were lower in the CZP-treated population including OLE (ER 4.33/100 PY). 44 patients developed tuberculosis (IR 0.47/100 PY), 39 from high endemic regions. 58 deaths occurred in CZP-exposed patients (IR 0.63/100 PY) and 70 developed malignancies excluding non-melanoma skin cancer (IR 0.76/100 PY), including five lymphomas (IR 0.05/100 PY).

conclusionsNo new or unexpected safety signals associated with CZP emerged in this updated long-term safety analysis. While SIE rates were higher for CZP than for placebo in RCT, the rate decreased with continued exposure to CZP. These rates are consistent with data previously reported for CZP and other tumour necrosis factor inhibitors.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, RheumatoidCertolizumab PegolHumansImmunoglobulin Fab FragmentsImmunosuppressive AgentsPolyethylene GlycolsRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedCertolizumab PegolImmunoglobulin Fab FragmentsImmunosuppressive AgentsPolyethylene GlycolsAnti-TNFInfectionsRheumatoid ArthritisTuberculosis

Identifiers

PMID24092417
PMCPMC4283674

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.