The biggest trial in rheumatoid arthritis last year was the ORAL Start trial of tofactinib monotherapy in RA, according to Graeme Jones from the Menzies Institute in Tasmania.
After giving delegates some amusing ways of remembering the different nomenclatures we have for DMARDs these days — BO (you stink) and BS (we probably don’t need to spell this one out) Jones said results from the ORAL Start trial showed that tofacitinib monotherapy beat MTX for both signs and symptoms of RA and x-ray progression.
“We now have two agents that work well as monotherapy however if we are to look at tofacitinib in terms of efficacy we’ve also got to look at it in terms of toxicity,” he told a packed plenary session called the Year in Review and The Year to Come.
A summary from phase 3 trials showed that with all biologics the serious infection rate was around 5 per 100 patient years with two exceptions — abatacept and etanercept.
“There seem to be two that are safer in the longer term and I think most of us would accept this,” he told delegates.
With tofacitinib the serious infection rate was 3 per 100 patient years, a figure that Jones said looked reassuring from an overall infection rate.
However the elephant in the room was herpes zoster, he said.
Data published last year showed the rate of herpes zoster in biologic naïve patients in Australia was about 1% per annum, for patients on an anti-TNF was about 2% per annum and about 3% for patients on tofacitinib.
“This is not a generalised form of zoster, it tends to be localised, but in my view patients should all be vaccinated prior to going on this particular therapy,” he said.