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Safety and Dosing: CIMZIA safety profile in nr-axSpA

Safety profile through 52 weeks in the nr-axSpA trial (C-axSpAnd)1,5

TEAEs through Week 52 in C-axSpAnd64

  CIMZIA (n=159) n (%) Placebo (n=158) n (%)
Any TEAE 120 (75.5) 101 (63.9)
Serious TEAEs 8 (5.0) 3 (1.9)
Drug-related TEAEs 48 (30.2) 23 (14.6)
Deaths 0 0
TEAEs of interest    
Opportunistic infections 0 0
Tuberculosis 0 0
Malignant or unspecified tumors 2 (1.3) 1 (0.6)
Serious cardiovascular events 0 0
Hematopoietic cytopenia 0 0
Serious bleeding events 0 0
Hepatic events* 9 (5.7) 4 (2.5)
Hypersensitivity/anaphylactic reactions 0 0
Demyelinating disorders 0 0

Adverse events in ≥5% of patients in C-axSpAnd5

  CIMZIA (n=159) n(%) Placebo (n=158) n(%)
Bronchitis 8 (5.0) 5 (3.2)
Upper respiratory tract infection 30 (18.9) 16 (10.1)
Nasopharyngitis 21 (13.2) 13 (8.2)
CPK increased 8 (5.0) 4 (2.5)
Headache 11 (6.9) 7 (4.4)
Diarrhea 8 (5.0) 10 (6.3)

The adverse events observed in CIMZIA patients with nr-axSpA are consistent with clinical experience1

*The majority of hepatic events were transient in nature and occurred in patients with either a medical history of prior hepatic-related events and/or who were using concomitant medications that are associated with the potential development of hepatic events. The most frequently reported hepatic adverse event in both treatment groups was an increase in ALT (CIMZIA group: 3.1% [5/159], IR=3.5/100 patient-years; placebo group: 1.9% [3/159], IR=3.2/100 patient-years).

ALT: alanine aminotransferase; CPK: creatine phosphokinase; IR: incidence rate; nr-axSpA: non-radiographic axial spondyloarthritis; TEAE: treatment-emergent adverse event.

Two formulation options for flexible dosing1

CIMZIA has two formulations for flexible, at-home administration with prefilled syringes, or in-office injection by a healthcare professional. Select a formulation based on your assessment of a patient’s ability to self-inject and/or whether they have access to a trained caregiver.

At-home Administration

CIMZIA Prefilled Syringe (PFS)

  • Injected by patient or caregiver
  • Covered under pharmacy benefit
  • Covered under Medicare Part D
  • Acquired through specialty pharmacy
OR

In-office Injection

CIMZIA Lyophilized Powder for Reconstitution (LYO)

  • Injected by healthcare professional
  • Covered under medical benefit
  • Covered under Medicare Part B

Prefilled syringe designed for comfort and control in partnership with
OXO, Good Grips®, and the associated logos are registered trademarks of Helen of Troy Limited and are used under license.

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