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Journal Der Deutschen Dermatologischen... Dec 2023
PubMed: 38082509
DOI: 10.1111/ddg.15253_g -
BMJ Case Reports Dec 2023
Topics: Humans; Nail Diseases; Nails, Malformed
PubMed: 38056926
DOI: 10.1136/bcr-2023-257235 -
BMC Pharmacology & Toxicology Nov 2023Pertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So, we evaluated the safety...
BACKGROUND
Pertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So, we evaluated the safety of pertuzumab by pharmacovigilance analyze based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) and find whether potential or uncertain adverse events were present.
METHODS
In disproportionality analysis, four algorithms were employed to detect the signals of pertuzumab from the FAERS between 2012 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the potential and high-ROR (reporting odds ratio) signals of pertuzumab. We also collected the onset times of pertuzumab-associated AEs.
RESULTS
From January 2012 to December 2022, there are 39,190,598 AEs reported from the FAERS database, of which 14,707 AEs listed pertuzumab as the 'primary suspected (PS)' drug. A total of 115 (46 potential) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained. Finally, we detected that the pertuzumab-induced AEs occurred in 12 organ systems. For pertuzumab, unexpected and significant PTs of AEs were found, including but not limited to below PTs: haematotoxicity, cardiotoxicity, cardiomyopathy, mitral valve incompetence, tachycardia, intestinal perforation, hemorrhoids, erysipelas, dehydration, pneumonitis, skin toxicity, onychomadesis, cyanosis, and circulatory collapse. We found there were 9 strong signals (5 potential safety signals) and 68 medium intensity signals (21 potential safety signals) according to IC (information component). The potential strong signals (IC > 3.0) were myelosuppression, cardiotoxicity, cardiac dysfunction, ejection fraction decreased, interstitial lung disease, and onychomadesis. Excluding unreported or unreasonable onset time reports, a total of 2016 AEs reported onset time and the median onset time was 117 days (4, 96), as median (Q1, Q3). Notably, most of the all AEs (n = 1133, 56%) and cardiac-related events (n = 405, 53%) all occurred within one month after pertuzumab therapy.
CONCLUSION
Analysis of FAERS data identified pertuzumab-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of pertuzumab. A significant association was detected between pertuzumab and some potential adverse events which should be regarded with some care. We have to pay attention to the first month after pertuzumab therapy and prepare emergency measures, especially for the elderly and patients with cardiovascular diseases.
Topics: Humans; Aged; Female; Cardiotoxicity; Adverse Drug Reaction Reporting Systems; Antibodies, Monoclonal, Humanized; Pharmacovigilance; Breast Neoplasms
PubMed: 37957717
DOI: 10.1186/s40360-023-00702-w -
Mayo Clinic Proceedings Nov 2023
Topics: Humans; Nail Diseases
PubMed: 37923530
DOI: 10.1016/j.mayocp.2023.06.006 -
Acta Dermato-venereologica Oct 2023
Topics: Humans; Nail Diseases; Nails, Malformed
PubMed: 37902467
DOI: 10.2340/actadv.v103.18251 -
Journal Der Deutschen Dermatologischen... Dec 2023
Topics: Humans; Pityriasis Lichenoides; Methotrexate; Nail Diseases; Nails, Malformed; Pityriasis
PubMed: 37847905
DOI: 10.1111/ddg.15253 -
Journal of the American Academy of... Feb 2024
Topics: Humans; T-Lymphocytes; Protein C; Antibodies, Bispecific; Multiple Myeloma; Receptors, G-Protein-Coupled
PubMed: 37742842
DOI: 10.1016/j.jaad.2023.08.094 -
Expert Opinion on Drug Safety 2023Guselkumab is an IL-23 inhibitor widely used for the treatment of moderate-to-severe plaque psoriasis. Our study aimed to characterize the profile of adverse events...
BACKGROUND
Guselkumab is an IL-23 inhibitor widely used for the treatment of moderate-to-severe plaque psoriasis. Our study aimed to characterize the profile of adverse events (AEs) associated with guselkumab from the FDA adverse event reporting system (FAERS).
METHODS
Disproportionality analysis including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) algorithms were used to assess the signals of guselkumab related AE.
RESULTS
A total of 22,950,014 reports were collected from the FAERS database, of which 24,312 reports regarding guselkumab as the 'primary suspected (PS)' AEs were identified. AEs induced by guselkumab were distributed in 27 organ systems. In this study, 205 significant disproportionality preferred terms (PTs) that matched four algorithms simultaneously were obtained for analysis. Unexpected significant AEs such as onychomadesis, malignant melanoma in situ, endometrial cancer, and erectile dysfunction were observed.
CONCLUSION
The clinical observed AEs, along with potential new AE signals associated with guselkumab were identified based on the analysis of FAERS data, which could provide valuable evidence for clinical monitoring, risk identification, and further safety studies of identification.
Topics: Male; Humans; United States; Drug-Related Side Effects and Adverse Reactions; Bayes Theorem; Antibodies, Monoclonal, Humanized; Skin Neoplasms; Adverse Drug Reaction Reporting Systems; United States Food and Drug Administration; Pharmacovigilance
PubMed: 37294594
DOI: 10.1080/14740338.2023.2223956 -
Clinical Breast Cancer Jun 2023Nail changes are among the most common dermatological adverse events in paclitaxel-receiving patients. Although effective, low-temperature prophylactic cryotherapy is...
BACKGROUND
Nail changes are among the most common dermatological adverse events in paclitaxel-receiving patients. Although effective, low-temperature prophylactic cryotherapy is discomforting and a potential cause of side effects, resulting in low patients' adherence.
PATIENTS AND METHODS
A phase II single-arm study evaluating mild cryotherapy for the reduction of 12-week, grade 2 nail toxicity was conducted on 67 taxane-naïve breast cancer patients (age 18-74 years) undergoing weekly adjuvant chemotherapy with paclitaxel. Instant-ice packs were fixed over the fingers and toes for a total of 70 minutes during paclitaxel infusion at a temperature between -5 °C and +5 °C. Nail toxicity was evaluated weekly (CTCAE vs 4.03), including grade 2 (ie, onycholysis, subungual hematoma, onychomadesis) and grade 1 nail toxicities.
RESULTS
Twelve patients experienced grade 2 nail toxicities (17.9%, 95% confidence interval [CI] 9.6%-29.2%; median time to onset: 56 days): onycholysis was the most frequent grade 2 toxicity (13.4%), followed by subungual hematoma (9.0%) and onychomadesis (1.5%). Grade 1 toxicity occurred in 33 patients (63.5%, 95% CI 49.0%-76.4%) with nail discoloration representing by far the most frequent toxicity (59.6%). Seventeen patients (25.4%) reported no nail toxicity. 62.7% of patients reported no pain and 22.4% suffered moderate pain. No patient experienced severe pain or others adverse effects.
CONCLUSIONS
Instant-ice pack is a feasible prophylactic intervention for nail toxicity, well tolerated by patients and with limited impact on routine workload. It could be considered for patients refusing (or interrupting) cryotherapy, and it can be implemented when frozen gloves management is not feasible.
Topics: Adolescent; Adult; Aged; Female; Humans; Middle Aged; Young Adult; Breast Neoplasms; Cryotherapy; Ice; Nail Diseases; Onycholysis; Paclitaxel
PubMed: 36997403
DOI: 10.1016/j.clbc.2023.03.004 -
Cureus Dec 2022Nail changes elicited by Ibrutinib are relatively infrequent but are reported in the literature. Herein, we report on two cases that developed Ibrutinib-induced nail...
Nail changes elicited by Ibrutinib are relatively infrequent but are reported in the literature. Herein, we report on two cases that developed Ibrutinib-induced nail toxicities. A 63-year-old female, with relapsing mantle cell lymphoma on Ibrutinib 560mg/day for seven months developed paronychia, onychomadesis, Beau's lines, nail fragility, and brittleness over fingernails and toenails. On the other hand, an 80-year-old male with chronic lymphoid leukemia developed a bloody papule with hemorrhagic crust and nail-plate abnormalities. Skin toxicities manifested eight months after initiating Ibrutinib therapy. From a clinical perspective, Ibrutinib-induced chronic paronychia and PG have been established. All other PG triggers have been ruled out. After the cessation of Ibrutinib, the PG improved for both cases. The exact pathogenesis of PG induced by Ibrutinib is not yet understood but it had been compared to retinoid-related changes. Thus, further research and reporting of similar cases should be done to further understand the pathophysiology of such manifestations.
PubMed: 36712781
DOI: 10.7759/cureus.32943