Reuters Health Information: Noninvasive test may detect worsening fibrosis in some psoriasis patients on methotrexate
Noninvasive test may detect worsening fibrosis in some psoriasis patients on methotrexate
Last Updated: 2017-08-31
By Marilynn Larkin
NEW YORK (Reuters Health) - NASH FibroSure, a noninvasive test for nonalcoholic steatohepatitis, may be useful for monitoring changes in hepatic fibrosis among patients with psoriasis who are receiving methotrexate therapy, researchers suggest.
Methotrexate is widely used as a first-line therapy for severe, long-term psoriasis. However, it can cause hepatic fibrosis over the long term, requiring monitoring by liver biopsy, according to Dr. Clayton Green of Marshfield Clinic, in Wisconsin, and colleagues.
The team investigated whether a noninvasive approach to fibrosis monitoring - NASH FibroSure (LabCorp), a blood test similar to the FibroTest but specifically developed for patients with nonalcoholic fatty liver disease - might be an effective alternative to biopsy for detecting NASH in patients with psoriasis.
The researchers retrospectively analyzed records for 129 psoriasis patients receiving methotrexate treatment at Marshfield Clinic, as reported in JAMA Dermatology, online August 23.
Of the 69 patients who underwent NASH FibroSure testing before starting methotrexate, 19 (28%) had elevated fibrosis scores and 54 (78%) had elevated steatosis scores.
The 107 patients (57 women, 50 men; mean age, 83) who underwent NASH FibroSure testing while taking methotrexate were eligible for correlation analyses. Among this group, the cumulative methotrexate dose corresponded, in women only, to a significant association with a higher NASH FibroSure hepatic fibrosis score.
The combination of age 65 or older and worsening hepatic fibrosis scores did not correlate significantly with cumulative methotrexate dose; however, again in women only, there was a statistically significant worsening of fibrosis scores for those with a body-mass index of 28 or higher. The authors suggest that, for women, obesity influences the progression of fibrosis scores.
Score-based patient management varied, including switching to another agent or methotrexate dose reduction. Only one patient underwent a liver biopsy that confirmed steatosis but did not detect fibrosis.
The authors conclude, "The NASH FibroSure test may be used for monitoring of hepatic fibrosis scores in patients with psoriasis who are taking methotrexate; worsening fibrosis scores can indicate the need to switch to an alternative systemic agent without performing a liver biopsy."
Dr. Green told Reuters Health by email, "More research is needed, as this test is not FDA-approved for methotrexate monitoring, and randomized controlled clinical trials comparing the performance of the NASH FibroSURE test to hepatic biopsy or to hepatic imaging have not yet been performed."
Dr. Roger Ho, assistant professor in the Ronald O. Perelman Department of Dermatology at NYU Langone in New York City, said "There is certainly an unmet need to find better ways to monitor for potential liver toxicity in psoriasis patients who are being treated with methotrexate."
"Liver biopsy has always been the gold standard, but that is invasive, has risks, and is subject to sampling error," he told Reuters Health by email. "It would be nice to have a noninvasive or serum blood test that can be performed prior to and during methotrexate treatment to see if the status of the patient's liver is suitable for (such) treatment and if the patient is developing liver fibrosis secondary to methotrexate treatment, respectively."
"It's interesting to suggest the use of the NASH FibroSure risk score in our psoriasis patients treated with methotrexate," he said. "However, I would be cautious in using it to accomplish either or both objectives."
"This risk score was developed and validated for patients with NAFLD," he noted. "While many of our psoriasis patients have some degree of NAFLD, not all psoriasis patients have it, so strictly speaking the results are not going to be valid or accurate for all our psoriasis patients."
"Even when we single out its use on psoriasis patients with pre-existing NAFLD," he continued, "the sensitivity and specificity, as provided in the article, for detecting risks of significant fibrosis or steatosis is pretty low."
"Finally, the risk score is calculated based on a number of different variables, including the patient's age, weight, glucose and triglycerides levels, all of which change with time," he noted. "So, any changes in the risk score cannot solely be attributed to the increase in cumulative methotrexate dose."
"Until this risk score is refined to be more generalizable to all populations with greater sensitivity and specificity, and a controlled trial of its use in psoriasis versus non-psoriasis patients, or methotrexate-treated psoriasis patients versus non-methotrexate-treated patients is performed," he concluded, "I have reservations about formulating my management plan based on it."
JAMA Dermatol 2017.