Table.

Rates of all treatment-emergent AEs through week 252.

 N = 127
Total PY of follow-up465.1
No. of events, per 100 PY of follow-up
Any AE969 (208.4)
SAEs36 (7.7)a
AEs leading to discontinuation30 (6.5)
Infectionsb428 (92.0)
      Serious infections18 (3.9)
      Opportunistic infectionsc2 (0.4)
      Tuberculosis1 (0.2)
Malignancies1 (0.2)d
Infusion reactions11 (2.4)e
Deaths1 (0.2)f
AEs occurring in ≥ 5% of participants
      URI37 (29.1)
      Nasopharyngitis30 (23.6)
      Gastroenteritis17 (13.4)
      Urinary tract infection12 (9.4)
      Pharyngitis11 (8.7)
      Tonsillitis10 (7.9)
      Varicella8 (6.3)
      Viral URI8 (6.3)
      Respiratory tract infection7 (5.5)
      Rhinitis7 (5.5)
      Nausea16 (12.6)
      Vomiting14 (11.0)
      Abdominal pain10 (7.9)
      Upper abdominal pain8 (6.3)
      Diarrhea8 (6.3)
      JIA28 (22.0)
      Arthritis11 (8.7)
      Headache19 (15.0)
      Epistaxis8 (6.3)
      Allergic conjunctivitis9 (7.1)
      Increased ALT8 (6.3)

  • Values are expressed as n (%).

  • ↵a Cellulitis, pneumonia, sepsis, and varicella (each event occurred in 2 participants), as well as disseminated tuberculosis, Escherichia infection, furuncle, disseminated herpes zoster, infective exacerbation of bronchiectasis, streptococcal pneumonia, septic shock, tonsillitis, constipation, Crohn disease, gastritis, calcinosis, drug intolerance, temperature regulation disorder, myopericarditis, supraventricular tachycardia, glaucoma, retinal detachment, generalized anxiety disorder, major depression, suicidal ideation, hypersensitivity, clavicle fracture, systemic lupus erythematosus, cutaneous T cell lymphoma, hydronephrosis, pleural effusion, and cyanosis (each event occurred in 1 patient).

  • ↵b Infection as assessed by investigators.

  • ↵c Opportunistic infections were identified using a standardized MedDRA version 25.0 query of opportunistic infections with the scope of narrow.38

  • ↵d Stable, stage 1A cutaneous T cell lymphoma (verbatim term: mycosis fungoides) reported 55 days after the third GOL infusion in a participant with a JIA duration of 0.9 years with eczema and skin lesions at study entry who had no prior biologic or Janus kinase inhibitor use and had discontinued MTX after week 8.

  • ↵e Eleven infusion reactions occurred over 10 infusions.

  • ↵f One death due to septic shock was reported at week 78. AE: adverse event; ALT: alanine aminotransferase; GOL: golimumab; JIA: juvenile idiopathic arthritis; MedDRA: Medical Dictionary for Regulatory Activities; MTX: methotrexate; PY: patient-years; SAE: serious adverse event; URI: upper respiratory tract infection.