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Miscellaneous Drugs during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Ustekinumab is a monoclonal antibody that blocks the production of inflammatory factors associated with plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Meta-analysis showed no increased frequency of birth defects (5 percent, 95 percent CI: 2–8 percent) associated with first trimester exposure to ustekinumab in 216 infants whose mothers used the drug (Nielsen et al., 2020).
Inflammatory Bowel Disease
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Ustekinumab: This is a IgG1 monoclonal anti-IL 12-23 antibody more commonly used for psoriasis but now approved for CD. Data regarding safety in pregnancy is limited to case series and registry data [98, 99]. While ustekinumab may be continued during pregnancy, the limited safety data necessitates careful counseling [30]. There is limited data to support safety of ustekinumab with breastfeeding and recommendations are conflicting [30, 86, 100].
Skin disease
Published in Catherine Nelson-Piercy, Handbook of Obstetric Medicine, 2020
There are few data for the newer anti-IL biologics such as ustekinumab (anti-IL 12 and 23) and secukinumab (anti-IL 17). Small case series suggest ustekinumab is safe when used to treat IBD (inflammatory bowel disease) in pregnancy.
A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults
Published in Expert Opinion on Investigational Drugs, 2023
Christopher Wynne, Paul Hamilton, Kristi McLendon, Heimo Stroissnig, Matthew Smith, Paul Duijzings, Ruth Ruffieux, Hendrik Otto, Abid Sattar, Halimu N. Haliduola, Steffen Leutz, Fausto Berti
The protein content for EU-RP was found to deviate from the nominal and expected value of 90 mg/mL. The mean actual protein content of the dose administered was slightly higher than the nominal 45 mg dose in the AVT04 and US-RP groups and lower in the EU-RP group, resulting in a dosing bias of 104.3% and 104.5% in the AVT04 and US-RP groups, respectively, and 97.9% in the EU-RP group. The impact of this deviation on ustekinumab exposure was assessed. As pre-specified in the study protocol and SAP, protein content normalization was implemented for dose-dependent PK parameters. Following protein content normalization, the exposure PK parameters for ustekinumab were similar across the 3 treatment groups: Cmax (ranging from 3761.3 to 3876.0 ng/mL) and the AUC (AUC0-inf ranging from 30 79,700 to 33 69,848 h·ng/mL; AUC0-t ranging from 29 34,704 to 31 53,938 h·ng/mL; Table 3).
Comparative real-world effectiveness of vedolizumab and ustekinumab for patients with ulcerative colitis: a GETAID multicentre cohort study
Published in Scandinavian Journal of Gastroenterology, 2022
Antoine Meyer, Mathurin Fumery, Laurent Peyrin-Biroulet, Jérôme Filippi, Romain Altwegg, Yoram Bouhnik, Melanie Serrero, David Laharie, Xavier Roblin, Maria Nachury, Vered Abitbol, Guillaume Cadiot, Stephane Nancey, Matthieu Allez, Cyrielle Gilletta, Lucine Vuitton, Guillaume Savoye, Stephane Nahon, Anne Bourrier, Anthony Buisson, Guillaume Bouguen, Arnaud Bourreille, Stephanie Viennot, Franck Carbonnel, Aurelien Amiot
In the present study, the benefit of vedolizumab compared to ustekinumab was less pronounced in patients with haemoglobin levels < 13 g/dL for short-term assessment (week 14) and CRP levels > 10 g/dL for the long-term assessment (week 52). Such a difference was previously reported by our groups in patients with Crohn’s disease [32,33]. It could be speculated that the benefit of ustekinumab could be greater in patients presenting with a higher systemic inflammatory burden. Indeed, it is believed that vedolizumab needs more time than anti-TNF therapy to exert its full efficacy whereas vedolizumab demonstrated similar kinetics of efficacy to adalimumab in randomized controlled trials of patients with UC [34]. An ongoing gain of effectiveness beyond week 14 is however suggested as a higher treatment persistence rate is observed in patients treated with vedolizumab compared to those treated with ustekinumab.
Spotlight on the treatment armamentarium of concomitant psoriasis and inflammatory bowel disease: a systematic review
Published in Journal of Dermatological Treatment, 2022
Claudio Conforti, Caterina Dianzani, Iris Zalaudek, Michele Cicala, Paolo Persichetti, Roberta Giuffrida, Silviu-Horia Morariu, Nicoleta Neagu
Ustekinumab might be an effective biologic treatment in patients with concomitant psoriasis and Crohn’s disease, or even ulcerative colitis. Further clinical trials and real-life studies are warranted. As for Guselkumab and other new molecules, further clinical trials and real-life studies are needed to confirm their efficacy and safety. TNF inhibitors, with the exception of Etanercept, still seem to be the best option for patients with concomitant psoriasis and IBD, in spite of the paradoxical psoriasis reactions that might appear. IL-17 inhibitors and Etanercept remain an important therapeutic option for patients with psoriasis or psoriatic arthritis, but the potential to exacerbate IBD must be considered. Newer molecules require further clinical trials and real-life studies in order to confirm their efficacy and safety.