Patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) who receive treatment with tofacitinib are at increased risk for herpes zoster (HZ) infection; however, these events are typically mild to moderate in severity and can be managed with antiviral therapy and/or temporary discontinuation of tofacitinib, according to findings from a post hoc analysis published in Rheumatology and Therapy.
The objective of the current study was to determine the outcomes and management of HZ events in patients with PsA and RA treated with tofacitinib.
Using data from 21 RA clinical studies and 3 PsA clinical studies, a post hoc analysis was conducted to assess the outcomes of HZ events and changes to tofacitinib treatment following the first and second HZ events.
One or more HZ events were recorded among 783 of 7061 patients (11.1%) with RA who received tofacitnib, with an incidence rate of 3.6 per 100 patient-years (95% CI, 3.4-3.9 per 100 patient-years). No significant differences in baseline demographic and clinical characteristics was reported between 720 patients who experienced a single HZ event and 63 patients who experienced multiple HZ events.
Treatment with tofacitinib in patients with RA was temporarily discontinued in response to the first HZ event in 42.8% of patients, while in 47.3% of patients, treatment remained unchanged, and in 9.1% of patients, tofacitinib was permanently discontinued. Of the 783 patients with HZ, 87.5% received antiviral treatment following their first HZ event and 90.5% received antiviral treatment following their second HZ event.
For patients with PsA, 1 or more HZ event was recorded in 36 of 783 patients (4.6%) who received tofacitinib. In all patients, except 1, a single HZ event was recorded. Treatment with tofacitinib was temporarily discontinued in response to the first HZ event in 66.7% of patients, while in 30.6% of patients, treatment remained unchanged, and in 2.8% of patients, tofacitinib was permanently discontinued.
First HZ events were resolved in 97.6% of patients with RA (median time to resolution, 22 days) and in 94.4% of patients with PsA (median time to resolution, 20.5 days). Second HZ events resolved in 96.8% and 100% of patients with RA and PsA, respectively.
Among patients with RA, median time-to-resolution to first HZ events was numerically shorter for patients with a history of HZ prior to tofacitinib than those without a history of HZ (16.5 vs 22 days) and shorter for single dermatomal than multidermatomal cases (21.0 vs 25 days), those with antiviral use within 3 days than no use (18.0 vs 24.0 days), and with corticosteroid use than no use (21.0 vs 23.0 days).
Among patients with PsA, time-to-resolution was numerically lower for single dermatomal than multidermatomal cases (median, 19.0 vs 24.0 days) and with antiviral use than no use (median, 19.5 vs 51.5 days), but it was numerically higher for patients with corticosteroid use within 14 days prior to the event than no treatment (median, 25.5 vs 19.5 days) and those receiving an average dose of tofacitinib 10 mg twice daily compared with 5 mg twice daily (median, 28.0 vs 19.0 days).
The study had several limitations, including small sample sizes, the analysis of time to HZ resolution not accounting for whether antiviral treatment was received, and limited follow-up period.
“In patients receiving tofacitinib treatment for RA or PsA, the majority of first or recurrent HZ events reported were nonserious, mild or moderate in severity, and were clinically manageable (eg, with use of antiviral therapy and/or temporary discontinuation of tofacitinib treatment), resolving in most patients,” the researchers concluded.
Disclosure: This research was supported by Pfizer Inc. Please see the original reference for a full list of authors’ disclosures
Winthrop KL, Curtis JR, Yamaoka K, et al. Clinical management of herpes zoster in patients with rheumatoid arthritis or psoriatic arthritis receiving tofacitinib treatment. Rheumatol Ther. Published online December 6, 2021. doi:10.1007/s40744-021-00390-0