medwireNews: Researchers have evaluated the risk for developing cancer or serious infection among rheumatoid arthritis (RA) patients receiving treatment with Janus kinase (JAK) inhibitors.
“Although several randomized controlled trials have shown the efficacy of JAK inhibitors compared with methotrexate, there are many concerns about their safety,” Maria Lopez-Olivo (The University of Texas MD Anderson Cancer Center, Houston, USA) told delegates at the EULAR 2018 meeting in Amsterdam, the Netherlands.
She added that malignancies and infections have been reported among patients receiving treatment with the first two JAK inhibitors to be approved, tofacitinib and baricitinib.
To assess the risk for these adverse events, Lopez-Olivo and colleagues conducted a systematic review and meta-analysis of data from more than 13,000 patients who participated in 36 randomized trials of JAK inhibitors that are currently approved or in phase III testing. JAK inhibitors were compared with placebo, methotrexate, or adalimumab in these trials.
Reported rates of malignancies ranged from 0% to 1.90%, with the most common types being lung and nonmelanoma skin cancer, while 0.40–5.45% of patients developed serious infections.
There was no statistically significant difference in the risk for malignancy among patients treated with JAK inhibitors alone or in combination with methotrexate versus methotrexate monotherapy, but “patients in the JAK inhibitor groups had higher rates,” said Lopez-Olivo.
We will probably only have a final answer when we have an update in 5 years' time
She noted that there were also numerically higher rates of malignancy among patients treated with JAK inhibitors versus adalimumab, but rates were comparable among those treated with JAK inhibitors compared with placebo.
The team found that a similar proportion of patients given JAK inhibitors versus control treatment developed serious infections, defined in the majority of trials as life-threatening infections or those resulting in hospitalization. However, Lopez-Olivo pointed out that there was a trend towards higher risk for serious infection with higher doses of tofacitinib, baricitinib, or upadacitinib.
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