Anti-inflammatory Drugs

 

Baricitinib

QT EFFECTs of Baricitinib in New Drug Application (FDA.gov)

Baricitinib is a low-potency blocker of the hERG channel (IC50=60 μg/mL). No significant QTc prolongation effect of 40 mg single dose baricitinib was detected in a dedicated TQT study. The largest upper bound of the 2-sided 90% CI for the mean difference between baricitinib and placebo was below 10 ms, the threshold for regulatory concern as described in the ICH E14 guideline.

 

Sarilumab

Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis

Paul Emery, Juan Rondon, Janie Parrino, Yong Lin, Claudia Pena-Rossi, Hubert van Hoogstraten, Neil M H Graham, Nancy Liu, Anne Paccaly, Richard Wu, Alberto Spindler, Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis, Rheumatology, Volume 58, Issue 5, May 2019, Pages 849–858, https://doi.org/10.1093/rheumatology/key361

No QT effects reported.

Pharmaceutical Approval Update (Sarilumab)

Kaufman M. B. (2017). Pharmaceutical Approval Update. P & T : a peer-reviewed journal for formulary management42(9), 562–580.

No QT effects reported.

Sarilumab Clinical Review (FDA.org)

A formal QT study was not required as biologic products like sarilumab are generally not expected to interact with cardiac ion channels. The QT interval was evaluated in the clinical trials that were part of the RA clinical development program. No clinical safety signals related to the QT interval were identified.