Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study

Clowse, Megan E.B.; Förger, Frauke; Hwang, Caroline; Thorp, John M.; Dolhain, Radboud J E M; Tubergen, Astrid van; Shaughnessy, Laura; Simpson, Jeff; Teil, Marie; Toublanc, Nathalie; Wang, Maggie; Hale, Thomas W.

doi:10.1136/annrheumdis-2017-211384

Cited by 142 publications

(111 citation statements)

References 37 publications

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“…In addition, gastric digestion substantially reduced human milk Igs in term neonates, but not in premature neonates (Demers-Mathieu et al, 2018). In a recent clinical study of lactating women who had been given a modified (PEGylated) therapeutic monoclonal IgG, only minimal concentrations were identified in breast milk, which supports the specificity of Ig secretion into milk (Clowse et al, 2017). Although the specific differences in colostrum composition and Ig uptake in neonates have not been robustly established, the available nonclinical models are likely to overpredict lactational transfer of macromolecules.…”

Section: Macromolecular Absorptionmentioning

confidence: 89%

Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

et al. 2018

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A thorough knowledge of the newborn (age, birth to 1 month postpartum) infant's gastrointestinal tract (GIT) is critical to the evaluation of the absorption, distribution, metabolism, and excretion (ADME) of orally administered drugs in this population. Developmental changes in the GIT during the newborn period are important for nutrient uptake as well as the disposition of orally administered medications. Some aspects of gastrointestinal function do not mature until driven by increased dietary complexity and nutritional demands later in the postnatal period. The functionalities present at birth, and subsequent maturation, can also impact the ADME parameters of orally administered compounds. This review will examine some specific contributors to the ADME processes in human neonates, as well as what is currently understood about the drivers for their maturation. Key species differences will be highlighted, with a focus on laboratory animals used in juvenile toxicity studies. Because of the gaps and inconsistencies in our knowledge, we will also highlight areas where additional study is warranted to better inform the appropriate use of medicines specifically intended for neonates.

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Section: Macromolecular Absorptionmentioning

confidence: 89%

Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

et al. 2018

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“…С учетом этого применение ИНФ может быть безо-пасно, по данным Европейской антиревматической лиги (EULAR,) до 20-й недели беременности, по данным British Society for Rheumatology/British Health Professionals in Rheumatology (BSR/BHPR) -до 16-й не-дели; АДА и ЭТЦ -в течение первых двух триместров, их применение в III триместре возможно лишь по жизнен-ным показаниям; данных по голимумабу и ТЦЗ в насто-ящее время недостаточно, чтобы судить о возможности их использования при беременности [16,17]. На настоя-щий момент ГИБП с наилучшим профилем безопасно-сти на всем протяжении беременности, а также при лак-тации является ЦЗП [16,17,26], который относится к группе ингибиторов ФНОα и представляет собой пэги-лированные антитела класса IgG1, лишенные, в отличие от других ингибиторов ФНОα, Fc-фрагмента, который, как известно, отвечает за способность антител проникать через плацентарный барьер за счет связывания со специ-фическим Fc-рецептором (FcRn) [18,27,28]. В исследо-вании U. Mahadevan и соавт.…”

Section: Discussionunclassified

Certolizumab Pegol in the Treatment of Takayasu Arteritis: The First Experience and Prospects

Novikov¹,

Smitienko²,

Соколова³

et al. 2018

rsp

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Certolizumab pegol (CZP) is the only pegylated biological agent (BA) that does not contain an Fc fragment, which minimizes its transplacental transfer. Takayasu arteritis mostly occurs in reproductive-aged women.Objective: to evaluate the efficacy and safety of CZP used to treat standard immunosuppressive therapy-resistant Takayasu arteritis.Subjects and methods. The retrospective study enrolled 6 female patients aged 18 to 35 years with Takayasu arteritis who received CZP. The median disease duration before BA usage was 66 months (24 to 204 months). The median duration of immunosuppressive therapy prior to CZP treatment was 92 months (14 to 132 months). All the female patients had taken glucocorticoids and methotrexate before and during CZP therapy. Only four patients had received two to five immunosuppressive drugs at different times prior to BA administration. Three patients had previously used other BAs. The disease activity was determined by the National Institute of Health (NIH) criteria. The Indian Takayasu Clinical Activity Score (ITAS2010) was used. The disease activity was recorded in all the patients prior to CZP therapy.Results and discussion. The median duration of CZP treatment was 17 months (6 to 24 months). The median erythrocyte sedimentation rate after CZP usage decreased from 22.5 to 10.5 mm/h; the median C-reactive protein level dropped from 7.8 to 0.39 mg/dl (p<0.05), the median daily dose of prednisolone was reduced from 20 to 8.75 mg (p<0.05). All the patients achieved complete remission an average of 4 months after starting CZP therapy. Three patients were still in remission after 12–24 months. One relapse of the disease was recorded following 24 months. ITAS2010 reduced from 1–4 to 0 in five patients and to 2 in one patient with recurrence. There was a good tolerance in five female patients. The adverse events were herpes labialis in two cases, community-acquired pneumonia in one case, and postoperative abscess in one case too.Conclusion. CZP in Takayasu arteritis was shown to be an effective drug for remission induction and maintenance. The presented results of the first experience in treating this disease with CZP are indicative of its promising further investigation as a steroid-sparing drug in patients with refractory vasculitis. One of the important advantages of CZP is its supposed high safety throughout pregnancy.

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“…При наличии клинической необходимости терапия цертолизумаба пэголом может быть продолжена на протяжении всего периода гестации. В исследовании CRADLE продемонстрировано, что концентрация цертолизумаба пэгола в грудном молоке является очень низкой и находится в безопасном диапазоне [31]. Таким образом, цертолизумаба пэгол является единственным ГИБП, который может обеспечить эффективный контроль заболевания пациентки не только до беременности, но также при наличии клинической необходимости на всем протяжении беременности и в период грудного вскармливания.…”

Section: применения цертолизумаба пэгола во время беременности и лактunclassified

Certolizumab pegol: new opportunities for treatment of moderate to severe plaque psoriasis

Кубанов

Бакулев

Глузмин

et al. 2019

Vestnik dermatologii i venerologii

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Tumor necrosis factor alpha (TNF-α) is one of the key inflammatory cytokines in the pathogenesis of psoriasis and psoriatic arthritis, and its inhibition with genetically engineered biological drugs ensures control of the main symptoms of these diseases. Certolizumab pegol is a PEGylated (linked to polyethylene glycol) Fab’ fragment of a monoclonal antibody that inhibits human TNF-α. It is approved for treatment of moderate to severe plaque psoriasis and psoriatic arthritis. This review summarizes the results of randomized clinical trials of efficacy and safety of certolizumab pegol in plaque psoriasis (CIMPASI 1, CIMPASI 2, and CIMPACT) and psoriatic arthritis (Rapid-PsA). The represented data demonstrate high efficacy of certolizumab pegol is bio-naïve patients and in patients previously exposed to other TNF inhibitors or IL17 inhibitors. The absence of the Fc-fragment in certolizumab pegol ensures minimal to no placental transfer of the drug and enables its usage during the entire pregnancy.Conflict of interest: the authors state that there is no potential conflict of interest requiring disclosure in this article.

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Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study

Cited by 142 publications

References 37 publications

Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

Certolizumab Pegol in the Treatment of Takayasu Arteritis: The First Experience and Prospects

Certolizumab pegol: new opportunities for treatment of moderate to severe plaque psoriasis

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