Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper

Yeung, Jensen; Gooderham, Melinda; Grewal, Parbeer; Hong, Chih‐Ho; Lansang, Perla; Papp, Kim; Poulin, Yves; Turchin, Irina; Vender, Ronald

doi:10.1177/1203475420928376

Cited by 16 publications

(18 citation statements)

References 54 publications

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“…One hundred and ninety-three ixekizumab-exposed pregnancies were recorded in the ixekizumab integrated safety database, of which 99 were maternal exposure pregnancies (58 in clinical trials, 41 during post-marketing surveillance). The majority of maternal exposures occurred in the first trimester of pregnancy, a time period before active transfer of IgG across the placenta occurs (13). A review of this data did not identify any congenital malformations resulting from maternal exposure in clinical trials, while one event of congenital malformation was identified during post-marketing surveillance.…”

Section: Discussionmentioning

confidence: 88%

“…Human immunoglobin G (IgG), the predominant means of fetal immunity, crosses the placental barrier in a linear fashion as the pregnancy progresses, with the greatest transfer of IgG in the third trimester (13). Preferential transport occurs for IgG subclass 1 (IgG1), followed by IgG4 (13); therefore, as an IgG4, ixekizumab may be transmitted from the mother to the developing fetus (9). However, transplacental passage of ixekizumab is estimated to be low during the early phases of pregnancy, when Fc receptors have yet to develop on fetal trophoblasts (14).…”

Section: Introductionmentioning

confidence: 99%

“…Hence, only limited amounts of ixekizumab should theoretically reach the fetus during the first trimester of pregnancy. Substantial transfer of ixekizumab across the placenta is not expected until mid-gestation, particularly during the third trimester (13).…”

Section: Introductionmentioning

confidence: 99%

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Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab

Egeberg

Iversen

Kimball

et al. 2021

Journal of Dermatological Treatment

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Background: Psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are chronic inflammatory diseases that often affect women of childbearing age. Detailed information about pregnancy and related outcomes across these indications in patients exposed to ixekizumab is lacking. Objectives: To evaluate pregnancy outcomes after maternal or paternal exposure to ixekizumab in patients with psoriasis, PsA, or axSpA. Methods: Pregnancy cases from clinical trials and post-marketing reports, associated with either maternal or paternal exposure to ixekizumab cumulatively through 22 March 2019, were identified in the Eli Lilly Global Safety Database and described separately. Results: One hundred and ninety-three ixekizumab-exposed pregnancies were identified. Maternal exposure occurred in 51.3% of pregnancies (clinical trials: n ¼ 58; post-marketing: n ¼ 41). The majority of paternal exposure pregnancies occurred in clinical trials (91 of 94). Live births were reported for 53.8 and 61.1% of known outcomes in maternal exposure pregnancies during clinical trials and postmarketing surveillance, respectively. No congenital malformations resulting from maternal exposure were reported in clinical trials: one case, not causally related to ixekizumab therapy, was recorded in the post-marketing setting. Conclusions: This integrated safety analysis provides relevant information for clinicians treating patients with psoriasis, PsA, or axSpA with ixekizumab. No new safety signals were identified in patients receiving ixekizumab.

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Section: Discussionmentioning

confidence: 88%

Section: Introductionmentioning

confidence: 99%

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Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab

Egeberg

Iversen

Kimball

et al. 2021

Journal of Dermatological Treatment

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“…To our knowledge, there are no studies conducted evaluating the safety of tildrakizumab during breast feeding. Due to tildrakizumab's large molecular structure, it is unlikely to be absorbed by the infant and is likely to be metabolized by the infant's gastrointestinal tract ( 132 , 133 ).…”

Section: Safety Profile Of Tildrakizumabmentioning

confidence: 99%

A Review of the Efficacy and Safety for Biologic Agents Targeting IL-23 in Treating Psoriasis With the Focus on Tildrakizumab

et al. 2021

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Psoriasis is a chronic and debilitating inflammatory immune-mediated skin disorder. Several cytokines including interleukin (IL)-23 were demonstrated to play a central role in the pathogenesis of this disease. Treatment options for psoriasis range from topical to systemic modalities, depending on the extent, anatomical locations involved and functional impairment level. Targeting cytokines or their cognate receptors that are involved in disease pathogenesis such as IL-12/23 (i.e., targeting the IL-12p40 subunit shared by these cytokines), IL-17A, IL-17F, IL-17RA, and TNF-α using biologic agents emerged in recent years as a highly effective therapeutic option for patients with moderate-to-severe disease. This review provides an overview of the important role of IL-23 signaling in the pathogenesis of psoriasis. We describe in detail the available IL-23 inhibitors for chronic plaque psoriasis. The efficacy, pharmacokinetic properties, and the safety profile of one of the most recent IL-23 biologic agents (tildrakizumab) are evaluated and reviewed in depth.

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“…Despite the large number of publications to date, not all factors of the etiology and pathogenesis of psoriasis have been definitively elucidated, especially in women of reproductive age depending on hormonal status [6].…”

mentioning

confidence: 99%

Clinical considerations for the management of psoriasis in women with disorders of the menstrual cycle

Dyulmesova-Bilash

2021

J Educ Health Sport

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Introduction. Psoriasis in women of reproductive age is one of the most pressing medical and social problems. The consequence of psoriasis disease is a significant decrease in the quality of life, disability of patients, difficulties in creating a family and deterioration of family relations, significant psychological discomfort. Objective of the study: to increase the effectiveness of treatment of women with psoriasis with menstrual irregularities by means of pathogenetically substantiated therapy based on the study of hormonal changes. Materials and research methods. The study included 130 women who were divided into three groups: the main group – 75 women with psoriasis with menstrual irregularities, who were randomized into 3 subgroups: 1a – 25 patients who will receive standard psoriasis therapy; 1b – 25 patients, in addition to the standard treatment of psoriasis, will receive gestagens for 3 months; 1c – 25 patients, in addition to the standard treatment of psoriasis, will receive a preparation of an dry extract of herb of creeping anchors for 3 months. The comparison group consisted of 25 women with psoriasis without hormonal disorders, comparable in age and social status with the study group. The control group – 30 apparently healthy women, comparable in age and social status with the study group. Research results. In patients of the main group who received standard psoriasis therapy (1a); who received progestogens for 3 months in addition to standard psoriasis treatment (1b) and, in addition to the standard treatment of psoriasis, who received the preparation of an dry extract of herb of anchors creeping for 3 months (1c), before the start of the treatment, the ratio of LH / FSH – luteinizing hormone (LH) and follicle-stimulating hormone (FSH) was below normal, which indicates a certain deficit in LH production relative to FSH values. In parallel, in these cohorts, the production of prolactin was increased, which suppresses the formation of FSH and LH in the pituitary gland. Changes in the production of gonadotropic hormones are a reaction to the existing deficiency or excess of sex hormones. In the main 1a, 1b and 1c in groups, estradiol values were within the normal range with progesterone deficiency in the luteal phase. The testosterone value in all study groups did not deviate from the standard values. Conclusions. The obtained results of the survey indicate the need to increase the effectiveness of treatment of women with psoriasis with menstrual irregularities by involving measures aimed at correcting hormonal status in complex therapy.

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Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper

Cited by 16 publications

References 54 publications

Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab

Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab

A Review of the Efficacy and Safety for Biologic Agents Targeting IL-23 in Treating Psoriasis With the Focus on Tildrakizumab

Clinical considerations for the management of psoriasis in women with disorders of the menstrual cycle

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