The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands
CONCLUSION: The results showed that the odds of reporting an AEFI after COVID-19 vaccination is significantly higher in the presence of some comorbidities whilst flare-ups are uncommon after receiving COVID-19 vaccination in people with rheumatic disease. In-depth research is needed to validate our results and unravel the observed associations from a mechanistic perspective.PMID:37796980 | DOI:10.1080/14740338.2023.2267971 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 5, 2023 Category: Drugs & Pharmacology Authors: C Ouaddouh J W Duijster T Lieber F P A M van Hunsel Source Type: research

Efficacy and safety of spesolimab for the management of generalized pustular psoriasis: a drug safety evaluation
Expert Opin Drug Saf. 2023 Sep 28. doi: 10.1080/14740338.2023.2265295. Online ahead of print.ABSTRACTINTRODUCTION: Generalized pustular psoriasis (GPP) is a rare form of psoriasis (less of 1% of cases). Currently, GPP is recognized as a clinical entity, distinguished from plaque psoriasis. However, there are not guidelines for GPP management and treatments are often derived from plaque psoriasis. Therefore, conventional systemic drugs are usually used as first-line treatment options, and biologics are still used off label. Recently, spesolimab, an anti-IL36 receptor humanized IgG1 monoclonal antibody, has been specifically...
Source: Expert Opinion on Drug Safety - September 28, 2023 Category: Drugs & Pharmacology Authors: Luca Potestio Elisa Camela Sara Cacciapuoti Fabrizio Martora Luigi Guerriero Luigi Fornaro Angelo Ruggiero Matteo Megna Source Type: research

Comparative effectiveness and safety of drug therapy for chronic urticaria: a network meta-analysis and risk-benefit assessment
CONCLUSION: Regarding risk-benefit assessment, OMA 300 mg emerges as the optimal pharmacological intervention for CU, while OMA 150 mg stands as a secondary alternative compared to H1 antihistamines and cyclosporine.PMID:37750025 | DOI:10.1080/14740338.2023.2262377 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 26, 2023 Category: Drugs & Pharmacology Authors: Tian Qian Xia Jiang Daojun Zhang Yao Song Fei Hao Source Type: research

Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research

Janus kinase inhibitor-Tofacitinib associated with pemphigus: an analysis of the FDA adverse event reporting system data
CONCLUSION: Pemphigus, a rare and potentially fatal adverse event, was found to occur more frequently in patients receiving Tofacitinib. High-risk individuals were identified as female, age between 40-49, or with rheumatoid arthritis. Medication, adverse events, and underlying disease conditions were identified as potential contributing factors. Rheumatology and dermatology specialists should exercise increased vigilance in clinical practice.PMID:37722813 | DOI:10.1080/14740338.2023.2248872 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Li Wang Bin Zhao Source Type: research

Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research

Janus kinase inhibitor-Tofacitinib associated with pemphigus: an analysis of the FDA adverse event reporting system data
CONCLUSION: Pemphigus, a rare and potentially fatal adverse event, was found to occur more frequently in patients receiving Tofacitinib. High-risk individuals were identified as female, age between 40-49, or with rheumatoid arthritis. Medication, adverse events, and underlying disease conditions were identified as potential contributing factors. Rheumatology and dermatology specialists should exercise increased vigilance in clinical practice.PMID:37722813 | DOI:10.1080/14740338.2023.2248872 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Li Wang Bin Zhao Source Type: research

Adverse event profile of CGRP monoclonal antibodies: findings from the FDA adverse event reporting database
CONCLUSION: We identified numerous shared underlying signals (overlapping signals) for CGRP-mAbs as suspected drugs in multiple systems and organs. The unlabeled common signals may indicate potential safety issues. In addition, the underlying safety signals varied among the four CGRP-mAbs, particularly in the cardiovascular system, and further studies are needed to confirm these associations and the potential clinical implications.PMID:37720989 | DOI:10.1080/14740338.2023.2250720 (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 18, 2023 Category: Drugs & Pharmacology Authors: Qi Wang Jingfang Liu Hao Sun YongFei Dong WeiLiang Tan Zaixiang Tang YiGuo Jiang Source Type: research