Tofacitinib is effective as monotherapy in some patients with psoriatic arthritis following withdrawal of background methotrexate, Australian-led research shows.
A 12-month sub-study of 180 patients found no clinically meaningful differences in efficacy in those taking tofacitinib 5mg twice daily as monotherapy with those taking the JAK inhibitor alongside continued methotrexate.
Patients taking part in the study had already had completed 24 months or more of tofacitinib treatment alongside methotrexate as part of the OPAL Balance trial before they were randomised.
Reporting the results in The Lancet Rheumatology, investigators led by Professor Peter Nash of Griffith University, Queensland, said the safety profile was similar in each treatment group but a greater proportion of patients taking tofacitinib plus methotrexate had increases in concentrations of liver enzymes.
It is the first randomised controlled trial to assess tofacitinib as a monotherapy and in addition to providing further evidence of the efficacy of the drug in psoriatic arthritis, it also suggests that some patients who are in a stable disease state might be able to discontinue methotrexate “without an adverse effect on their overall disease activity or health-related quality of life”, they concluded.
They pointed out that treat-to-target, including withdrawal or tapering of medication is as yet an emerging concept in psoriatic arthritis and the effect of background methotrexate in combination with advanced therapies has been an area of interest.
More research is needed on the assessments of tofacitinib monotherapy in patients reporting flare or worsening of psoriatic arthritis, they added.
Current guidance is somewhat conflicting with some clinical guidelines recommending treating patients with biological disease-modifying antirheumatic drugs but the 2019 EULAR guidelines recommend continuing methotrexate with a bDMARD in patients who tolerate it well and reducing the methotrexate dose in those showing a good response.
Speaking with the limbic, study co-author Dr Laura Coates, NIHR Clinician Scientist at the Oxford Psoriatic Arthritis Centre, said currently tofacitinib has to be used alongside methotrexate because that is how the original trials were done.
“This study doesn’t change the label (unfortunately) but does give reassurance that if people do well, you can taper the methotrexate in stable patients without a significant risk of flare in any domains of disease.
“Unfortunately we don’t yet have any data on people starting tofacitinib monotherapy right from the beginning – it would be interesting to see if people really need the MTX or not.”
She added that a fair number of patients can’t tolerate methotrexate either due to intolerance or safety concerns like fatty liver which is a big issue for our patients in terms of comorbidities.
“But the licence still says it has to be prescribed alongside methotrexate so we are still restricted despite this data.”
The study was funded by Pfizer, maker of tofacitinib.