Safety and tolerability of tildrakizumab, an anti–interleukin-23p19 monoclonal antibody, in patients with chronic plaque psoriasis over two years of treatment: Results from long-term extensions of two phase III clinical studies (reSURFACE 1 and reSURFACE 2)

2018 ◽  
Vol 79 (3) ◽  
pp. AB251
Keyword(s):  
Monoclonal Antibody ◽  
Plaque Psoriasis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Treatment Results ◽  
Chronic Plaque Psoriasis ◽  
Two Phase

scholarly journals Clinical Efficacy or Tildrakizumab in Patients with Chronic Plaque Psoriasis Over 2 Years of Treatment: Results from Long-Term Extensions to 2 Phase 3 Clinical Studies

2018 ◽  
Vol 2 ◽  
pp. S4 ◽  
Author(s):  
Kim Papp ◽  
Kristian Reich ◽  
Andrew Blauvelt ◽  
Diamant Thaci ◽  
Rodney Sinclair ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Plaque Psoriasis ◽  
Clinical Studies ◽  
Treatment Results ◽  
Chronic Plaque Psoriasis ◽  
Phase 3

Abstract not available. Study supported by Merck & Co., Inc.

Bezlotoxumab: Could This be the Answer for Clostridium difficile Recurrence?

2017 ◽  
Vol 51 (9) ◽  
pp. 804-810 ◽  
Author(s):  
Ryan W. Chapin ◽  
Tiffany Lee ◽  
Christopher McCoy ◽  
Carolyn D. Alonso ◽  
Monica V. Mahoney
Keyword(s):  
Monoclonal Antibody ◽  
Clostridium Difficile ◽  
English Language ◽  
Adverse Drug Events ◽  
Data Extraction ◽  
Standard Of Care ◽  
Phase Iii ◽  
Relative Reduction ◽  
Two Phase ◽  
Mesh Terms

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of bezlotoxumab (BEZ), a novel monoclonal antibody against Clostridium difficile toxin B. Data Sources: A PubMed search was conducted for data between 1946 and April 2017 using MeSH terms bezlotoxumab, MK-6072, or MDX-1388 alone and the terms Clostridium difficile combined with monoclonal antibody or antitoxin. Study Selection and Data Extraction: The literature search was limited to English-language studies that described clinical efficacy, safety, and pharmacokinetics in humans and animals. Abstracts featuring prepublished data were also evaluated for inclusion. Data Synthesis: BEZ is indicated for adult patients receiving standard-of-care (SoC) antibiotics for C difficile infection (CDI) to prevent future recurrence. Two phase III trials—MODIFY I (n = 1452) and MODIFY II (n = 1203)—demonstrated a 40% relative reduction in recurrent CDI (rCDI) with BEZ compared with placebo (16.5% vs 26.6%, P < 0.0001). The most common adverse drug events associated with BEZ were mild to moderate infusion-related reactions (10.3%). Conclusions: In patients treated with SoC antibiotics, BEZ is effective in decreasing rCDI. BEZ has no apparent effect on treatment of an initial CDI episode. In light of increasing rates of CDI, BEZ is a promising option for preventing recurrent episodes. The greatest benefit has been demonstrated in high-risk patients, though the targeted patient population is yet to be defined.

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