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Tofacitinib treatment led to small, reversible serum creatinine increases in RA patients
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Patients with rheumatoid arthritis who underwent treatment with tofacitinib experienced small, reversible mean increases in serum creatinine that plateaued early, according to study results.
Researchers pooled serum creatinine (SCr) values and renal adverse event data from five phase 3 and two long-term extension studies, exploring dose-response relationships and associations with inflammation using phase 2 data before confirming with phase 3 data.
Study results showed that in phase 3, least squares mean SCr differences from placebo to month 3 were 0.02 mg/dl for tofacitinib 5 mg twice daily and 0.04 mg/dl for tofacitinib 10 mg twice daily. The researchers also confirmed that 33% or greater increases in SCr from baseline were reported in 17 patients who received tofacitinib 5 mg twice daily and in 23 patients who received tofacitinib 10 mg twice daily during months 0 to 3.
Throughout the phase 3 and long-term extension studies, the researchers found SCr elevation plateaued and remained within normal limits. Small, reversible effects of tofacitinib on mean SCr were demonstrated by exposure-response modeling and significant effects of C-reactive protein (CRP) on model parameters.
Patients with higher baseline CRP or greater CRP decreases following tofacitinib treatment had the largest increases in SCr, according to the researchers. Overall, 22 patients treated with tofacitinib experienced clinical acute renal failure; however, this occurred mostly in patients who had concurrent serious illness.
Disclosure: See the study for a full list of all authors’ relevant financial disclosures.
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