An Integrated Analysis of Tofacitinib Safety Save

Since its US approval in 2012, tofacitinib has become a widely used treatment for rheumatoid arthritis (RA).

Whether you're impressed with its efficacy, or distressed with its side effects, its track record is voluminous and has been recently reviewed.

An integrated analysis of data from global clinical trials of tofacitinib in phases I–III and long term extension studies was done and extends upon the previous safety reports for tofacitinib which focused on specific adverse events (AEs). This analysis includes patients with up to 8.5 years of tofacitinib exposure, allowing estimation of rates for safety events of interest. Data were collected for all treatment-emergent AEs and serious AEs (SAEs) and independend experts evaluated the results.

Out of 6194 patients who received tofacitinib, the most common AEs (all causality) were nasopharyngitis, upper respiratory tract infection and urinary tract infection (UTI).

Pneumonia, herpes zoster (HZ), UTI and cellulitis were among the most often reported serious infections. Duration of treatment had no effect on incidence rate.

HZ was seen in 703 patients and 92%of the cases involved one dermatome only.

Malignancies (excluding non-melanoma skin cancer, NMSC) occurred in 173 patients and NMSC in 118 patients. Age-adjusted and sex-adjusted SIR for all malignancies (excluding NMSC) was was 1.0 (95% CI, 0.8 to 1.1) compared to the  SEER database. The SIRs (95% CI) for lymphoma, lung cancer and breast cancer were 2.6 (1.6 to 4.1), 1.4 (1.0 to 2.0) and 0.5 (0.3 to 0.7), respectively.

Twenty-two patients experienced GI perforations. All received concomitant therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.

This analysis of tofacitinib safety profile across the RA clinical programm with >6000 patients treated for up to 8.5 years demonstrated that AEs were stable oer time and no new safety signals were observed.