scholarly journals Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data

2019 ◽  
Vol 51 (1) ◽  
pp. 149-157 ◽  
Author(s):  
Timothy Card ◽  
Ryan Ungaro ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Gary Hantsbarger ◽  
...  
Keyword(s):  
Study Results ◽  
Post Marketing ◽  
Marketing Data

scholarly journals P724 Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S483-S484
Author(s):  
T Card ◽  
R Ungaro ◽  
F Bhayat ◽  
A Blake ◽  
G Hantsbarger ◽  
...  
Keyword(s):  
Study Results ◽  
Post Marketing ◽  
Marketing Data

scholarly journals Su1835 – Vedolizumab Use is Not Associated with Increased Malignancy Incidence: Gemini Long-Term Safety Study Results and Post-Marketing Data

2019 ◽  
Vol 156 (6) ◽  
pp. S-628 ◽  
Author(s):  
Timothy Card ◽  
Ryan C. Ungaro ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Gary Hantsbarger ◽  
...  
Keyword(s):  
Safety Study ◽  
Study Results ◽  
Post Marketing ◽  
Marketing Data

scholarly journals Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan

Breast Cancer ◽  
2021 ◽  
Author(s):  
Yucherng Chen ◽  
Satoshi Noma ◽  
Yoshio Taguchi ◽  
Masashi Takahashi ◽  
Junji Tsurutani ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Age Distribution ◽  
Metastatic Breast ◽  
Advanced Age ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Marketing Data

Abstract Background This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan. Methods Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data. Results Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status. Conclusion Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data

2016 ◽  
Vol 46 (2) ◽  
pp. 238-245 ◽  
Author(s):  
Maria Hoeltzenbein ◽  
Evelin Beck ◽  
Richa Rajwanshi ◽  
Carina Gøtestam Skorpen ◽  
Erhan Berber ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Safety Database ◽  
Post Marketing ◽  
Marketing Data ◽  
In Pregnancy

scholarly journals Progress in the Treatment of Migraine Attacks: From Traditional Approaches to Eptinezumab

2021 ◽  
Vol 14 (9) ◽  
pp. 924
Author(s):  
Damiana Scuteri ◽  
Giacinto Bagetta
Keyword(s):  
Chronic Migraine ◽  
Specific Treatment ◽  
Episodic Migraine ◽  
Migraine Treatment ◽  
Acute Migraine ◽  
Bothersome Symptom ◽  
Post Marketing ◽  
Marketing Data ◽  
Artery Disease ◽  
Traditional Approaches

Migraine is the second cause of disability and of lost years of healthy life worldwide. Migraine is characterized by recurrent headache attacks and accompanying disabling symptoms lasting 4–48 h. In episodic migraine, attacks occur in less than 15 days per month and in chronic migraine, in more than 15 monthly days. Whilst successful translation of pharmacological discoveries into efficacious therapeutics has been achieved in the preventative therapy of chronic migraine, treatment of acute migraine suffers the lack of effective advancements. An effective treatment affords complete freedom from pain two hours after therapy and provides the absence of the most bothersome symptom (MBS) associated with migraine after 2 h. However, available anti-migraine abortive treatments for acute attacks do not represent an effective and safe treatment for all the populations treated. In particular, the most used specific treatment is represented by triptans that offer 2-h sustained freedom from pain achieved in 18–50% of patients but they are contraindicated in coronary artery disease, stroke and peripheral vascular disease due to the vasoconstriction at the basis of their pharmacologic action. The most novel therapies, i.e., gepants and ditans, are without sufficient post-marketing data for secure use. Here, an attempt is proposed to analyse the rational basis and evidence in favour of investigating the efficacy and safety in acute migraine attacks of eptinezumab, i.e., monoclonal antibody (mAb) directed towards calcitonin gene-related peptide (CGRP) unique for intravenous infusion administration.

scholarly journals 2494. Real-World Use of Ibalizumab in Physician Office Infusion Centers (POICs)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S865-S865 ◽  
Author(s):  
Richard C Prokesch ◽  
Claudia P Schroeder ◽  
Thomas C Hardin ◽  
Lucinda J Van Anglen
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Real World ◽  
Clinical Trial Data ◽  
Cd4 Count ◽  
Drug Classes ◽  
Post Marketing ◽  
Marketing Data ◽  
Hiv 1

Abstract Background Ibalizumab-uiyk (IBA) was recently approved for the treatment of multi-drug-resistant HIV-1 infection in patients (pts) failing other antiretroviral regimens. Clinical trial data demonstrated a decrease in HIV-1 viral load in 83% and 43% of patients (n = 40) receiving IBA for 2 and 25 weeks (weeks), respectively. Real-world post marketing data are needed. This pilot study reports the experience of IBA utilization in POICs. Methods Medical records of patients receiving intravenous IBA from approval through April 2019 were reviewed. Data collected include demographics, infection and treatment history, IBA regimen and adverse events. Plasma HIV-1 RNA viral load (log10 copies/mL) and CD4 count (cells/µL) were collected at baseline and as available during therapy. Based on available follow-up (FU) labs, response was assessed at 4–10 weeks (FU 1), 14–22 weeks (FU 2), and 24–37 weeks (FU 3). Results Nine patients (mean age: 48 ± 11 years, 67% male) from 7 POICs received IBA for a median duration of 33 weeks (range 4–43). Median length of HIV-1 diagnosis was 22 years (range 8–25). Resistance to ≥1 drug in at least 3 drug classes was reported in 56%. All patients received at least one concurrent anti-retroviral agent. IBA was initiated at 2000 mg followed by 800 mg every 2 weeks. All patients received infusions as scheduled (151 total infusions) except for one requiring a second loading dose. Baseline mean CD4 count and viral load were 49 cells/µL and 4.9 log10 copies/mL, respectively. Labs obtained at FU 1 indicated a decrease in viral load of at least 0.5 log10 copies/mL in 6/8 patients (75%); a mean reduction of 2.1 ± 1.8 log10 copies/mL (Table 1). Mean HIV-1 titers available for patients at FU 2 (n = 6) and FU 3 (n = 7) were 3.1 ± 2.0 and 3.2 ± 2.6 log10 copies/mL, respectively. Mean CD4 counts were 65 ± 57 cells/µL at FU 1, 96 ± 61 cells/µL at FU 2 and 88 ± 82 cells/µL at FU 3. Adverse events were reported in 8 patients (89%), most common itching/rash, diarrhea and abdominal pain. None resulted in discontinuation of IBA. Conclusion This study confirms the antiviral activity of IBA in patients with advanced HIV-1 infection in the real-world setting. We observed well-tolerated therapy with an early reduction in HIV-1 viral load of 75%, followed by a 43% reduction ≥24 weeks, consistent with the clinical trial. Disclosures All authors: No reported disclosures.

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

scholarly journals Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Tigran Makunts ◽  
Ila M. Saunders ◽  
Isaac V. Cohen ◽  
Mengxing Li ◽  
Talar Moumedjian ◽  
...  
Keyword(s):  
Cancer Immunotherapy ◽  
Immune Checkpoint ◽  
Kinase Inhibitor ◽  
Checkpoint Inhibitors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Post Marketing ◽  
Marketing Data ◽  
Cancer Types ◽  
Tumor Types

AbstractAntibodies targeting the PD-1, PD-L1, and CTLA-4 immune checkpoint axis have been used in a variety of tumor types. They achieve anti-tumor activity through activating the patient’s own immune system to target immune response evading cancer cells. However, this unique mechanism of action may cause immune-related adverse events, irAEs. One of these irAEs is myocarditis which is associated with an alarming mortality rate. In this study we presented clinical cases of myocarditis from safety trial datasets submitted to the U.S. Food and Drug Administration, FDA. Additionally, we analyzed over fourteen million FDA Adverse Event Reporting System, FAERS, submissions. The statistical analysis of the FAERS data provided evidence of significantly increased reporting of myocarditis in patients administered immune checkpoint inhibitors alone, in combination with another immune checkpoint inhibitor, the kinase inhibitor axitinib, or chemotherapy, for all cancer types, when compared to patients administered chemotherapy. All combination therapies led to further increased reporting odds ratios of myocarditis. We further analyzed the occurrence of myocarditis by stratifying the reports into sub-cohorts based on specific cancer types and treatment/control groups in major cancer immunotherapy efficacy trials and confirmed the observed trend for each cohort.

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