The Safety Profile of the Short-Term Combination Therapy of Ticagrelor With PPI or H2RA in Patients With Acute STEMI Underwent PCI

2020 ◽  
Author(s):  
Peng Wei ◽  
Bin Zong ◽  
Xue-kui Liu ◽  
Miao-miao Zhang ◽  
Cui Yang ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Safety Profile ◽  
Short Term ◽  
Acute Stemi

Successful Combination Therapy for Amblyopia Secondary to Micro-Esotropia And Anisometropia

2021 ◽  
pp. 195-200
Keyword(s):  
Visual Acuity ◽  
Combination Therapy ◽  
Refractive Error ◽  
Combination Treatment ◽  
Current Treatment ◽  
Short Term ◽  
Eccentric Fixation ◽  
Case Summary ◽  
Vision Therapy ◽  
Spectacle Correction

Background: Micro-esotropia is a small-angle esodeviation typically less than nine prism diopters. Patients with this ocular condition often develop amblyopia due to the presence of a constant unilateral strabismus and an anisometropic refractive error in the deviated eye. Current treatment methods for strabismic and refractive amblyopia include spectacle correction, patching, and vision therapy (VT). Case Summary: A 9-year-old Asian female presented with a constant left primary micro-esotropia with unsteady eccentric fixation, contributing to mild amblyopia and frequent suppression in the left eye. She also had a hyperopic anisometropic refractive error. Combination treatment of in-office VT with short-term patching therapy (two hours per day) was administered, with the goal of improving her binocularity, fixation, and visual acuity. Conclusions: Amblyopia results from binocular dysfunction, therefore monocular patching therapy alone will not improve the underlying issue. VT is necessary to actively treat binocularity and subsequently improve visual acuity, while short-term patching can be used in combination to effectively target monocular accommodation and fixation.

Clinical activity of fianlimab (REGN3767), a human anti-LAG-3 monoclonal antibody, combined with cemiplimab (anti-PD-1) in patients (pts) with advanced melanoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9515-9515
Author(s):  
Omid Hamid ◽  
Ding Wang ◽  
Tae Min Kim ◽  
Sang-We Kim ◽  
Nehal J. Lakhani ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adrenal Insufficiency ◽  
Safety Profile ◽  
Phase 1 ◽  
Objective Response ◽  
Advanced Melanoma ◽  
Clinical Activity ◽  
Dose Escalation Study ◽  
Treatment Naïve ◽  
Grade 3

9515 Background: Fianlimab and cemiplimab are two high-affinity, fully human, hinge-stabilized IgG4 monoclonal antibodies. In a Phase 1 dose escalation study, fianlimab combined with cemiplimab showed an acceptable safety profile and some clinical activity in pts with advanced malignancies. Here, we present safety and clinical activity data from two expansion cohorts of pts with advanced melanoma (anti–programmed cell death/ligand-1 [anti–PD-(L)1] naïve or experienced) who were treated with fianlimab + cemiplimab and had an opportunity for first on-treatment tumor assessment (cut-off date: Jan 4, 2021). Methods: Pts with advanced melanoma who had no prior anti–PD-(L)1 treatment (naïve) or prior anti–PD-(L)1 treatment within 3 months of screening (experienced) received fianlimab 1600 mg + cemiplimab 350 mg by IV infusion every 3 weeks. Tumor measurements were performed every 6 weeks for the first 24 weeks and subsequently every 9 weeks per RECIST v1.1. Results: 48 pts with advanced melanoma were treated with the combination therapy: 33 were anti–PD-(L)1 naïve and 15 were anti–PD-(L)1 experienced (median age: 69 years vs 59 years; male: 66.7% vs 46.7%; Caucasian: 87.9% vs 60%). The safety profile (including immune-related adverse events [AEs]) of fianlimab + cemiplimab combination therapy was similar to that of anti–PD-1 monotherapy with one exception. The rate of adrenal insufficiency, 8.3% (4/48) of pts, is similar to the rate previously observed with anti–PD-1 + anti–cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) combination therapy but higher than that observed with anti–PD-1 monotherapy. Grade ≥3 treatment-emergent AEs (TEAEs) occurred in 35.4% (17/48) of patients; Grade ≥3 serious TEAEs occurred in 22.9% (11/48) of patients; 8.3% (4/48) of patients discontinued treatment due to a TEAE. The most common TEAEs were fatigue (n = 15, 31.3%) and rash (n = 11, 22.9%). By investigator assessment, objective response rate (includes unconfirmed complete [CR] and partial responses [PR]) was 63.6% (3 CRs and 18 PRs) for anti–PD-(L)1 naïve pts and 13.3% (1 CR and 1 PR) for anti–PD-(L)1 experienced pts. Median progression-free survival and median duration of response for the anti–PD-(L)1 treatment naïve cohort have not been reached. Prognostic clinical markers and tumor biomarkers such as expression of LAG-3, PD-L1, and major histocompatibility complex II are being evaluated. Recruitment is ongoing. Conclusions: The safety profile of fianlimab + cemiplimab is similar to that observed with cemiplimab monotherapy and other anti–PD-1s, with the exception of higher rate of adrenal insufficiency. Fianlimab + cemiplimab combination has shown clinical activity for pts with advanced melanoma that is similar to anti–PD-1 + CTLA-4 combination therapy, but with lower demonstrated rates of TEAEs. Clinical trial information: NCT03005782.

scholarly journals Safety profile of nivolumab (NIVO) and ipilimumab (IPI) combination therapy in patients (pts) with advanced melanoma (MEL)

2016 ◽  
Vol 27 ◽  
pp. vi385 ◽  
Author(s):  
M. Sznol ◽  
P.F. Ferrucci ◽  
D. Hogg ◽  
M. Atkins ◽  
P. Wolter ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Safety Profile ◽  
Advanced Melanoma

scholarly journals Pharmacokinetics and pharmacodynamics of natalizumab in pediatric patients with RRMS

2019 ◽  
Vol 6 (5) ◽  
pp. e591 ◽  
Author(s):  
Angelo Ghezzi ◽  
Giancarlo Comi ◽  
Luigi Maria Grimaldi ◽  
Lucia Moiola ◽  
Carlo Pozzilli ◽  
...  
Keyword(s):  
Safety Profile ◽  
Time Course ◽  
Pediatric Patients ◽  
Short Term ◽  
Elimination Phase ◽  
Relapsing Remitting ◽  
Distribution Phase

ObjectiveThis phase I study investigated pharmacokinetic (PK) and pharmacodynamic (PD) profiles of natalizumab in pediatric patients with relapsing-remitting MS (RRMS).MethodsPediatric patients with RRMS who were prescribed natalizumab 300 mg IV every 4 weeks were enrolled. Blood samples were collected on days 1, 2, 8, 15, and 22 and at weeks 4, 8, 12, and 16 to estimate PK parameters; PD properties were evaluated by measuring α4-integrin saturation and lymphocyte counts over time. Natalizumab's safety profile was also evaluated.ResultsPK parameters were similar to those reported in adult patients; natalizumab concentrations peaked approximately 1 day after infusion in most of the participants (Cmax 142.9 μg/mL, AUClast 47389.4 hr*μg/mL), followed by a biphasic decline with a rapid distribution phase and a slow elimination phase, with a terminal half-life of 215.1 hours. In terms of PD, both time course and magnitude of α4-integrin saturation and increase in lymphocyte counts were similar to those observed in adults. During the 16-week study follow-up, 3 adverse events attributed to natalizumab were observed; no unexpected safety events occurred.ConclusionsPK profile, α4-integrin saturation, lymphocyte counts, and safety observed in these pediatric patients are comparable to those reported in adults.Classification of evidenceThis study provides Class I evidence that natalizumab PK/PD parameters and safety profile are similar in adults and pediatric patients in the short term. Longer studies, also including a larger number of younger subjects (aged 10–12 years), are required to further inform about long-term PK and PD parameters in pediatric patients with MS.

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