scholarly journals Pharmacoethnicity of docetaxel-induced severe neutropenia: integrated analysis of published phase II and III trials

2011 ◽  
Vol 18 (1) ◽  
pp. 96-104 ◽  
Author(s):  
Ryoichi Yano ◽  
Aya Konno ◽  
Kyohei Watanabe ◽  
Hitoshi Tsukamoto ◽  
Yuichiro Kayano ◽  
...  
2021 ◽  
Vol 8 (1) ◽  
pp. e000464
Author(s):  
Raj Tummala ◽  
Gabriel Abreu ◽  
Lilia Pineda ◽  
M Alex Michaels ◽  
Rubana N Kalyani ◽  
...  

ObjectiveIn phase II and III trials, anifrolumab, a human monoclonal antibody that binds type I interferon receptor subunit 1, has shown efficacy in adults with moderate to severe SLE. We evaluated the safety and tolerability of anifrolumab using data pooled from these trials to more precisely estimate the rate and severity of adverse events (AEs).MethodsData were pooled from patients receiving monthly intravenous anifrolumab 300 mg or placebo in MUSE, TULIP-1 and TULIP-2. Key safety endpoints included percentages and exposure-adjusted incidence rates (EAIRs) of patients who experienced AEs, serious AEs (SAEs), AEs leading to discontinuation and AEs of special interest.ResultsDuring treatment, 86.9% of patients receiving anifrolumab 300 mg (n=459) experienced AEs (≥1) versus 79.4% receiving placebo (n=466), and 4.1% versus 5.2% experienced an AE leading to discontinuation of investigational product. SAEs (≥1) were experienced by 11.8% and 16.7% of patients receiving anifrolumab and placebo, respectively (EAIR risk difference (95% CI) −7.2 (−12.5 to –1.9)), including lupus exacerbations classified as SAEs (1.5% and 3%, respectively). Infections occurred in 69.7% and 55.4% of patients receiving anifrolumab and placebo, respectively; difference in reported rates was driven by herpes zoster (HZ) and mild and moderate respiratory (excluding pneumonia) infections. The risk of HZ was increased with anifrolumab versus placebo (6.1% vs 1.3%, respectively; EAIR risk difference (95% CI) 5.4 (2.8 to 8.4)); most HZ events were mild or moderate, cutaneous and resolved without treatment discontinuation. Serious infections occurred in 4.8% and 5.6% of patients receiving anifrolumab and placebo, respectively.ConclusionsIn this pooled analysis of 925 patients with moderate to severe SLE, monthly intravenous anifrolumab 300 mg was generally well tolerated over 52 weeks with an acceptable safety profile. Anifrolumab was associated with an increased incidence of HZ and respiratory tract infections and lower reported rate of SLE worsening as SAEs.


2016 ◽  
Vol 48 ◽  
pp. e93-e94
Author(s):  
R. Pencek ◽  
K. Lutz ◽  
T. Marmon ◽  
L. Macconell ◽  
L.A. Picaro ◽  
...  

2016 ◽  
Vol 2 (1) ◽  
pp. 91-114 ◽  
Author(s):  
William W. Busse ◽  
Leslie Andersen ◽  
Lucy Frith ◽  
Catherine Harvey ◽  
Loretta Jacques

2012 ◽  
Vol 20 (11) ◽  
pp. 2661-2668 ◽  
Author(s):  
Linda T. Vahdat ◽  
Eva S. Thomas ◽  
Henri H. Roché ◽  
Gabriel N. Hortobagyi ◽  
Joseph A. Sparano ◽  
...  

2013 ◽  
Vol 35 (2) ◽  
pp. 190-197 ◽  
Author(s):  
Mugdha Sitole ◽  
Matthew Silva ◽  
Linda Spooner ◽  
Morgan K. Comee ◽  
Michael Malloy

2018 ◽  
Vol 53 (4) ◽  
pp. 413-418 ◽  
Author(s):  
Sree S. Kolli ◽  
Sarah D. Gabros ◽  
Adrian Pona ◽  
Abigail Cline ◽  
Steven R. Feldman

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.


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