Evidence map›Paper›PMID 39065754›Full record

ArticlePharmaceuticals (Basel, Switzerland)2024

Pregnancy Recommendations Solely Based on Preclinical Evidence Should Be Integrated with Real-World Evidence: A Disproportionality Analysis of Certolizumab and Other TNF-Alpha Inhibitors Used in Pregnant Patients with Psoriasis.

Mario Gaio, Maria Giovanna Vastarella, Maria Giuseppa Sullo, Cristina Scavone, Consiglia Riccardi, Maria Rosaria Campitiello, Liberata Sportiello, Concetta Rafaniello

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. A review of core immuno-inflammatory mechanisms and key regulatory targets in psoriasis.American journal of clinical and experimental immunology · 2026
    Review
  5. Article
  6. Article
  7. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mario GaioCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.ORCID 0000-0003-4287-5510
Maria Giovanna VastarellaDepartment of Women, Child and General and Special Surgery, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.
Maria Giuseppa SulloAOU Policlinico, Università degli Studi della Campania "L. Vanvitelli", 80138 Naples, Italy.
Cristina ScavoneCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.ORCID 0000-0002-9216-922X
Consiglia RiccardiCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
Maria Rosaria CampitielloDepartment of Obstetrics and Gynaecology and Physiopathology of Human Reproduction, ASL Salerno, 84124 Salerno, Italy.
Liberata SportielloCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
Concetta RafanielloCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment for pregnant women with psoriasis is limited by the lack of information typically related to clinical trials. While anti-tumor necrosis factor (TNF) drugs offer therapeutic benefits, their safety during pregnancy is a concern. Notably, certolizumab is comparatively safer than adalimumab, etanercept, infliximab, and golimumab according to the current recommendations. Thus, this study aimed to conduct a pharmacovigilance comparative analysis of maternal and neonatal outcomes associated with certolizumab versus other anti-TNF drugs by using data from EudraVigilance. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with an anti-TNF drug and related to the pregnant patients with psoriasis from 2009 and 2023, focusing our analysis on the specific pregnancy outcomes and fetal/neonatal disorders. The most common pregnancy-related adverse event was spontaneous abortion, predominantly related to adalimumab and certolizumab. Certolizumab was also reported in cases of caesarean section, gestational diabetes, abortion, fetal death, fetal distress syndrome, pre-eclampsia, and premature separation of placenta. Generally, the findings from our study depicted a safety profile that overlapped for each anti-TNF drug, both in maternal/neonatal outcomes and other adverse events, suggesting no substantial differences between treatments. We advocate for further investigations before making concrete recommendations.

Indexed as

adalimumabcertolizumabetanerceptgolimumabinfliximabpharmacovigilancepregnancypsoriasissafetyTNF-alpha

Identifiers

PMID39065754
PMCPMC11279583

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Registered trials

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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.