CIMZIA® safety profile in plaque psoriasis

Adverse reactions occurring in ≥1% of CIMZIA-treated patients and more frequently than in placebo groups in psoriasis clinical trials at Week 161a

  CIMZIA
400 mg Q2W
N=342
% (n)		 CIMZIA
200 mg Q2Wf
N=350
% (n)		 Placebo
N=157
% (n)
Upper respiratory tract infectionsb 21.9%
(75)		 19.4%
(68)		 21.0%
(33)
Headachec 3.8%
(13)		 2.9%
(10)		 2.5%
(4)
Injection site reactionsd 3.2%
(11)		 1.7%
(6)		 0.6%
(1)
Cough 3.2%
(11)		 1.1%
(4)		 1.9%
(3)
Herpes infectionse 1.5%
(5)		 1.4%
(5)		 1.3%
(2)
  1. Pooled safety from CIMPASI-1, CIMPASI-2, and CIMPACT through Week 16.
  2. Upper respiratory tract infection cluster includes upper respiratory tract infection, pharyngitis bacterial, pharyngitis streptococcal, upper respiratory tract infection bacterial, viral upper respiratory tract infection, viral pharyngitis, viral sinusitis, and nasopharyngitis.
  3. Headache includes headache and tension headache.
  4. Injection site reactions cluster includes injection site reaction, injection site erythema, injection site bruising, injection site discoloration, injection site pain, and injection site swelling.
  5. Herpes infections cluster includes oral herpes, herpes dermatitis, herpes zoster, and herpes simplex.
  6. CIMZIA 200 mg Q2W patients received loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.

Pooled incidence rates per 100 patient-years for adverse events of interest at Week 165

  CIMZIA
400 mg Q2W
(95% CI)		 CIMZIA
200 mg Q2Wb
(95% CI)		 Placebo
(95% CI)
Serious AEs 15.6
(8.92, 25.34)		 4.7
(1.54, 11.04)		 15.4
(6.19, 31.72)
Serious infectionsa 1.9
(0.23, 6.94)		 0 0
Malignancies 1.0
(0.02, 5.33)		 0 0
See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma.
  1. Serious infections include all serious AEs reported in the system organ class of infections and infestations.
  2. CIMZIA 200 mg Q2W patients received loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
 

In clinical trials, the rates of reported elevated liver enzymes for CIMZIA were 2.3% for the 400 mg group and 4.3% for the 200 mg group compared to 2.5% for placebo1

 

A change in plaque psoriasis into a different psoriasis sub-type (including erythrodermic, pustular, and guttate) was observed in <1% of CIMZIA-treated subjects1

 

There were no new safety signals with longer-term exposure18,19a

AE, adverse event; SMQ, standardized MedDRA query; Q2W, every 2 weeks.

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