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  1. Malcolm
  2. General Nephrology Questions
  3. Friday, 27 February 2015
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In general, can biologic drugs be used safely in patients with renal disease. Namely, I'm referring to patients with impaired renal function.

 
Responses (2)
Accepted Answer Pending Moderation
Just wondering if you had a link to the paper on Humira and renal insufficiency-had a patient enquring about this recently.   Many thanks
  1. more than a month ago
  2. General Nephrology Questions
  3. # 1
Accepted Answer Pending Moderation
Biologic drugs comprise a large group of complex medications. It is difficult to generalize their safety as a class in patients with chronic kidney disease. Many of these drugs have in common large physical size owing to the fact that they are complex macromolecules. As such they would not be freely filtered at the level of the glomerulus nor easily secreted into the renal tubules, and therefore, the impact of renal clearance on their removal is likely less than for drugs which are small in molecular size and more easily filtered.

There are a number of commonly used Biologics in dermatologic, rheumatologic and gastrointestinal conditions where some information is known. I summarize a few of these below - though admittedly, the data are sparse:

Humira - In a small study of patients with renal insufficiency including some on maintenance hemodialysis, the use of Humira was not associated with an increase in adverse events nor was there any impact on renal function in those taking it.

Etanercept - In another small study of patients on hemodialysis, the pharmacokinetics of this etanercept (a soluble TNF-alpha receptor fusion protein) were similar to those with normal renal function.

Ustekinumab - A case report reports the successful use of this monoclonal antibody directed against interleukin 12 and interleukin 23 in a single patient with hemodialysis.

Rituximab - This monoclonal antibody to CD20 appears to be safe in patients with renal disease. In one case report, rituximab levels in a patient on hemodialysis were comparable to those seen in patients with normal kidney function. Furthermore, in the same study, no significant removal of the drug by hemodialysis was observed.
References
  1. http://onlinelibrary.wiley.com/enhanced/doi/10.1177/0091270011413894
  2. http://onlinelibrary.wiley.com/doi/10.1111/ijd.12163/abstract
  1. more than a month ago
  2. General Nephrology Questions
  3. # 2
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