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Systemic Lupus Erythematosus
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Maria A. Giraldo-Isaza, Bettina F. Cuneo
Certolizumab pegol: Likely safe in pregnancy. No increased risk of birth defects or adverse outcomes with the use of Certolizumab. Certolizumab does not cross the placenta as it does not have the antibody FC-region that facilitates the passage of immunoglobulins through the placenta. Therefore, its use appears to be acceptable during the entire pregnancy [50, 51].
Compatibility of commonly used drugs in lactation
Published in Amy Brown, Wendy Jones, A Guide to Supporting Breastfeeding for the Medical Profession, 2019
Babies of mothers with IBD on monoclonal antibodies should avoid live vaccines, especially rotavirus due to shedding into faeces. The mother is at risk of contracting virus from these. If vaccination is given, mother should wear gloves and be careful with hand hygiene. Infliximab – molecular weight 149,100. Poor oral bioavailability, RID 0.32–3.01%.Adalimumab – molecular weight 148,000. Poor oral bioavailability, RID 0.12%.Golimumab – molecular weight 150,000. Poor oral bioavailability.Certolizumab pegol – molecular weight 149,100. Poor oral bioavailability. RID 0.04–0.3%. Licensed for use in breastfeeding.
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Published in Caroline Ashley, Aileen Dunleavy, John Cunningham, The Renal Drug Handbook, 2018
Caroline Ashley, Aileen Dunleavy, John Cunningham
Clearance following subcutaneous dosing was estimated to be 21 mL/hour in a rheumatoid arthritis population pharmacokinetic analysis, with an inter-subject variability of 30.8% and an inter-occasion variability of 22%. The presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance. Compared with a 70 kg person, clearance is 29% lower and 38% higher, respectively, in individual RA patients weighing 40 kg and 120 kg.
Two cases of rheumatoid arthritis complicated by organising pneumonia successfully treated with tofacitinib therapy
Published in Modern Rheumatology Case Reports, 2021
Takao Kodera, Tomomi Tsutsumi, Yumiko Oka, Tomoki Takeda, Yuko Shirota, Junichi Kameoka
The pathogenesis of OP in patients treated with DMARDs is more complex to interpret than OP in untreated patients. Owing to their direct toxicity, DMARDs may affect the inflammatory process of RA in the lungs, causing OP and exacerbating the existing ILDs. Conventional DMARDs, such as gold salts, MTX, penicillamine, sulfasalazine, and cyclophosphamide, have been reported to cause OP [18], but several reports indicated that biologics also cause OP [3–5]. Among our cases, case 1 had a history of using three biologics (etanercept, adalimumab, and certolizumab pegol). Around 6 months after certolizumab pegol administration, she developed OP. Although the RA disease activity increased at the onset of OP, drug-induced OP could not be ruled out on the basis of the clinical manifestations. A case of drug-induced OP by certolizumab pegol reportedly had a severe clinical course and eventually led to death [16]. Case 1 also had a wide range of imaging findings and was intractable with repeated recurrences, indicating a critical situation. By contrast, case 2 developed OP during etanercept therapy, but OP was thought to have developed independently with etanercept therapy because the first onset of OP was at 2 years after discontinuation of etanercept therapy, and OP relapsed 3 months after PSL dose reduction, indicating the PSL dose dependent.
A multicenter, open-label study to evaluate the safe and effective use of a new electromechanical auto-injection device for self-injection of certolizumab pegol
Published in Expert Opinion on Drug Delivery, 2020
Daljit Tatla, Irina Mountian, Boglarka Szegvari, Brenda VanLunen, Michael Schiff
The primary objective of this study was to determine the proportion of patients able to safely and effectively self-inject certolizumab pegol (CZP) Q2 W or Q4 W using the e-Device at Visit 2. Patients’ ability to do so was evaluated by the HCP present, who documented any AEs that precluded continued use of the e-Device and confirmed complete dose delivery when the CZP-cassette containers were empty upon visual inspection. The secondary objective was to assess the ability of patients to safely and effectively self-inject CZP using the e-Device at Visit 1. Further objectives were to determine patient experience of self-injecting using the e-Device, measure injection site pain, to ascertain patient preference for the e-Device compared to their previous device (CZP PFS), and to evaluate the safety of CZP self-injection using the e-Device.
Biased anti-idiotype response in rabbits leads to high-affinity monoclonal antibodies to biologics
Published in mAbs, 2020
Christina Großerichter-Wagener, Dorien Kos, Astrid van Leeuwen, Lisanne Dijk, Jorn Jeremiasse, Floris C. Loeff, Theo Rispens
Immunizations were carried out as described previously.21 Briefly, F(ab’)2 fragments of the therapeutic antibodies were generated by pepsin digestion, except for belimumab, of which F(ab’)2 fragments were prepared via IdeS (Fabricator, Genovis) digestion. Certolizumab pegol is a PEGylated F(ab’) fragment and was used for immunizations without any modifications. Female New Zealand white rabbits were immunized with 100 μg/ml F(ab’)2 fragments/Montanide ISA-50 (Seppic, Paris, France) multiple times at 4-week intervals. Blood was drawn 9 d after the 2nd, 3rd, and 4th immunizations, and either collected as serum, or as EDTA blood. In the latter case, PBMCs were isolated by density centrifugation using Ficoll (GE Healthcare, Chalfont St. Giles, UK). PBMCs were stored in liquid nitrogen, and plasma was stored at −30 °C.