ArticleAnnals of the rheumatic diseases2017
Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study.
Article in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02154425 (A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia®), which is not on this map. Cited by 62 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)
Who cites it
62 citing papers in PubMed, 3 syntheses or guidelines pooled it, 172 citations in OpenAlex.
- Rational approach to the prescription of anti-rheumatic drugs in rheumatoid arthritis: a product leaflet-based strategy in Italy.Frontiers in immunology · 2024Pooled it
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases.Neurology(R) neuroimmunology & neuroinflammation · 2020Pooled it
- Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial.Journal of the European Academy of Dermatology and Venereology : JEADV · 2021Trial
- Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial.Clinical rheumatology · 2018Trial
- Hidradenitis Suppurativa from Preconception to Lactation: Clinical Treatment Decision-Making Review.Dermatology and therapy · 2026Review
- Residual Burden in Adalimumab-Treated Patients with Hidradenitis Suppurativa: An Observational Cohort Study Based on Insurance Claims in the USA.Drugs - real world outcomes · 2026Article
- Psoriasis and Psoriatic Arthritis in Pregnancy: Current Evidence and Clinical Considerations.Cureus · 2026Review
- Management and safety of somatostatin receptor ligands and pegvisomant in pregnant women with acromegaly: a narrative review of the literature.Endocrine · 2026Review
- Analysis of the potential for immunosuppression of infants with in-utero and breast milk exposure to antitumor necrosis factor alpha agents: are all agents equally safe?International journal of women's dermatology · 2025Review
- Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025Review
- Management of psoriasis in women 18 to 45 years of age in Australia and Japan: insights from patient and dermatologist surveys.International journal of women's dermatology · 2025Article
- On placental and lactational transfer of IgG-based therapeutic proteins - Current understanding and knowledge gaps from a clinical pharmacology perspective.Clinical and translational science · 2024Review
- Risk Assessment and Optimization for Pregnancy in Patients with Rheumatic Diseases.Diagnostics (Basel, Switzerland) · 2024Review
- [Treatment of psoriasis vulgaris : Therapy strategies for optimal patient-centered care].Dermatologie (Heidelberg, Germany) · 2024Review
- Successful Pregnancy Outcome in a Patient with Juvenile Idiopathic Arthritis in Adulthood, Amyloid A Amyloidosis, and Chronic Kidney Disease Using Tocilizumab with Strict Blood Pressure Control.Internal medicine (Tokyo, Japan) · 2024Article
- The Saudi consensus recommendations for the management of psoriatic arthritis (2023).Clinical rheumatology · 2024Review
- Clinical Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Moderate-to-Severe Psoriasis.Clinical pharmacokinetics · 2024Review
- Ornidazole Transfer into Colostrum and Assessment of Exposure Risk for Breastfeeding Infant: A Population Pharmacokinetic Analysis.Pharmaceutics · 2023Article
- Management Strategies for Pediatric Moderate-to-Severe Plaque Psoriasis: Spotlight on Biologics.Pediatric health, medicine and therapeutics · 2023Review
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWomen with chronic inflammatory diseases face uncertainty regarding the safety of biologics during breast feeding. CRADLE was the first industry-sponsored study to evaluate certolizumab pegol (CZP) concentrations in human breast milk and estimate average daily infant dose (ADID) of maternal CZP.
methodsCRADLE (NCT02154425) was a pharmacokinetic study of lactating mothers receiving CZP. After ≥3 CZP doses, breast milk samples were collected across one dosing period (14 days for 200 mg every 2 weeks [Q2W]; 28 days for 400 mg every 4 weeks [Q4W]). Optimal analytical methods were developed to determine CZP and polyethylene glycol (PEG) levels in breast milk. ADID and relative infant dose (RID) were estimated. Safety events in mothers and infants were assessed.
results19 CZP-treated mothers were screened; 17 entered the sampling period: 16 on 200 mg Q2W, 1 on 400 mg Q4W. 77/137 (56%) breast milk samples had no measurable CZP. For 4/17 mothers, all samples were below the lower limit of quantification (LLOQ). Estimated ADID was 0-0.0104 mg/kg/day; median RID: 0.15%. PEG was undetectable in 134/137 samples (results could not be determined in three samples). Infants of CZP-exposed mothers had a safety profile consistent with that of unexposed similar-age infants.
conclusionWhen quantifiable, CZP concentrations were <3× LLOQ (<1% plasma concentration observed with therapeutic dose), indicating no/minimal CZP transfer from plasma to breast milk. RID was 0.15% of maternal dose; <10% is considered unlikely to be of clinical concern. No PEG transfer was observed. CZP absorption by infants via breast milk is unlikely due to its low oral bioavailability and Fc--free molecular structure. These findings are reassuring and support continuation of CZP treatment during breast feeding. TRIAL REGISTRATION NUMBER: NCT02154425; Results.
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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.