Table 2

Summary of safety during the LTE study in the overall cohort treated with tofacitinib

Overall cohort (N=225)*
Patients with AEs, n (%)201 (89.3)
Total number of AEs1213
Patients with SAEs, n (%)34 (15.1)
Total number of SAEs39†
Patients who permanently discontinued due to AEs, n (%)29 (12.9)
Patients who temporarily discontinued or had dose reduced due to AEs, n (%)83 (36.9)
Most common AEs (≥5% by MedDRA Preferred Term), n (%)
 Upper respiratory tract infection48 (21.3)
 JIA exacerbation28 (12.4)
 Nasopharyngitis27 (12.0)
 Arthralgia22 (9.8)
 Viral infection22 (9.80)
 Urinary tract infection21 (9.3)
 Headache20 (8.9)
 Fever20 (8.9)
 Cough19 (8.4)
 Vomiting19 (8.4)
 Abdominal pain19 (8.4)
 Sinusitis17 (7.6)
 Influenza17 (7.6)
 SARS-CoV-2 test positive16 (7.1)
 COVID-1915 (6.7)
 Oropharyngeal pain15 (6.7)
 Arthritis14 (6.2)
 Nausea14 (6.2)
 Disease progression13 (5.8)
 Pharyngitis13 (5.8)
 Bronchitis12 (5.3)
 Ear infection12 (5.3)
AEs of special interest, n (%); IR‡ (95% CI)
 Deaths0; 0.00 (0.00 to 0.53)
 Active uveitis§2 (0.9); —
 Serious infections10 (4.4); 1.44 (0.69 to 2.65)
 Renal events8 (3.6); 1.16 (0.50 to 2.29)
 Herpes zoster (non-serious and serious)¶4 (1.8); 0.58 (0.16 to 1.47)
 Adjudicated opportunistic infections (excluding tuberculosis)**2 (0.9); 0.29 (0.04 to 1.03)
 Adjudicated tuberculosis0; 0.00 (0.00 to 0.53)
 Adjudicated gastrointestinal perforation0; 0.00 (0.00 to 0.53)
 Adjudicated hepatic events0; 0.00 (0.00 to 0.53)
 Adjudicated MAS††0; 0.00 (0.00 to 15.72)
 Adjudicated interstitial lung disease0; 0.00 (0.00 to 0.53)
 Adjudicated malignancies (excluding NMSC)0; 0.00 (0.00 to 0.53)
 Adjudicated NMSC0; 0.00 (0.00 to 0.53)
 Adjudicated MACE0; 0.00 (0.00 to 0.53)
 Adjudicated DVT0; 0.00 (0.00 to 0.53)
 Adjudicated PE0; 0.00 (0.00 to 0.53)
 ATE0; 0.00 (0.00 to 0.53)
Laboratory test abnormalities, n (%)‡‡
 Haemoglobin <0.8× LLN9 (4.0)
  <0.8× LLN23 (10.2)
  >1.2× ULN3 (1.3)
 AST >3.0× ULN0
 ALT >3.0× ULN6 (2.7)
 Cholesterol >1.3× ULN‡‡5 (2.3)
 Creatine kinase >2.0× ULN28 (12.4)
  • The safety analysis set included all patients with pcJIA, jPsA or ERA.

  • Safety assessments were reported from LTE baseline through to data cut-off. AEs and SAEs were assessed up to 365 days after the last dose of tofacitinib. Laboratory abnormalities were recorded up until the patient stopped treatment or the lag time expired.

  • *Mean total duration of tofacitinib treatment (median; range) was 36.7 (41.6; 1–103) months.

  • †By MedDRA System Organ Class, these were: gastrointestinal disorders (n=4); general disorders and administration site conditions (n=3); hepatobiliary disorders (n=2); infections and infestations (n=10); injury, poisoning and procedural complications (n=1); musculoskeletal and connective tissue disorders (n=5); nervous system disorders (n=2); pregnancy, puerperium and perinatal conditions (n=2); psychiatric disorders (n=8); renal and urinary disorders (n=1); reproductive system and breast disorders (n=1); and skin and subcutaneous tissue disorders (n=1).

  • ‡Number of patients with first event per 100 patient-years. For IRs, only patients with events during the risk period were included in the numerator. The risk period extended from the patient’s first dose of tofacitinib until the date of last dose of tofacitinib plus 28 days, last contact date or data cut-off, whichever occurred first.

  • §One patient had active uveitis at month 12; one patient had uveitis at month 27.

  • ¶Three patients with serious cases and one patient with a non-serious case.

  • **Two serious cases of herpes zoster were adjudicated as opportunistic infections.

  • ††Applicable to patients with sJIA without active systemic features only (N=11).

  • ‡‡Cholesterol was evaluated in 221 patients.

  • AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ATE, arterial thromboembolism; DVT, deep vein thrombosis; ERA, enthesitis-related arthritis; IR, incidence rate (patients with events per 100 patient-years); JIA, juvenile idiopathic arthritis; jPsA, juvenile psoriatic arthritis; LLN, lower limit of normal; LTE, long-term extension; MACE, major adverse cardiovascular event(s); MAS, macrophage activation syndrome; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients with events; N, number of patients evaluated; NMSC, non-melanoma skin cancer; pcJIA, polyarticular course juvenile idiopathic arthritis; PE, pulmonary embolism; SAEs, serious adverse events; sJIA, systemic juvenile idiopathic arthritis; ULN, upper limit of normal.