In the double-blind portion of the pivotal Phase 3 trial (Study JIA-I), infection was the most commonly reported adverse reaction (44.3%). The infections were generally mild to moderate in severity. ¹

• In the integrated safety population, 7 patients had serious infections during treatment with tofacitinib within the reporting period (up to 28 days after the last dose of study medication), representing an incidence rate of 1.92 patients with events per 100 patient-years: pneumonia, epidural empyema (with sinusitis and subperiosteal abscess), pilonidal cyst, appendicitis, escherichia pyelonephritis, abscess limb, and UTI.¹

The most common serious adverse reactions in RA clinical trials were serious infections.¹

Overall, the safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in patients with RA treated with XELJANZ.¹

• In the RA long-term safety all exposure population, the most common serious infections included pneumonia, herpes zoster, urinary tract infection, cellulitis, gastroenteritis and diverticulitis. Cases of opportunistic infections have been reported.¹
• The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.¹
• Combination therapy, 6, 12 or 24-month trials, rates of serious infections: 3.6 patients with events per 100 patient-years for XELJANZ 5mg twice daily plus DMARD vs. 1.7 per 100 patient-years for placebo plus DMARD.¹
• Monotherapy, 6-month and 24-month controlled clinical studies, rates of serious infections: 1.7 patients with events per 100 patient-years for XELJANZ 5mg twice daily vs. 1.9 per 100 patient-years for MTX.¹
• Long-term safety all-exposure population, rate of serious infections: 2.4 patients with events per 100 patient-years for XELJANZ 5mg twice daily.¹

• The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with XELJANZ monotherapy treatment groups.¹

• Events of gastrointestinal perforation have been reported in clinical studies although the role of JAK inhibition in these events is not known. 
• XELJANZ should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g. patients with a history of diverticulitis, patients with concomitant use of corticosteroids and/or non-steroidal anti-inflammatory drugs).¹
• Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.¹