stent or significantdisability/incapacity) was 0.5% in the 3 mg/kg infliximab group, 1.9% in the placebo group,and 1.6% in the 5 mg/kg infliximab group.
Among patients in the 2 Phase 3 studies, 12.4% of patients receiving infliximab 5 mg/kgevery 8 weeks through 1 year of maintenance treatment experienced at least 1 SAE in Study I.
In Study II, 4.1% and 4.7% of patients receiving infliximab 3 mg/kg and 5 mg/kg every8 weeks, respectively, through 1 year of maintenance treatment experienced at least 1 SAE.
One death due to bacterial sepsis occurred 25 days after the second infusion of 5 mg/kginfliximab. Serious infections included sepsis, and abscesses. In Study I, 2.7% of patientsreceiving infliximab 5 mg/kg every 8 weeks through 1 year of maintenance treatmentexperienced at least 1 serious infection. In Study II, 1.0% and 1.3% of patients receivinginfliximab 3 mg/kg and 5 mg/kg, respectively, through 1 year of treatment experienced atleast 1 serious infection. The most common serious infection (requiring hospitalization) wasabscess (skin, throat, and peri-rectal) reported by 5 (0.7%) patients in the 5 mg/kg infliximabgroup.
Two active cases of tuberculosis were reported: 6 weeks and 34 weeks after startinginfliximab.
In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who receivedinfliximab at any dose were diagnosed with at least one NMSC compared to 0 of 334 patientswho received placebo.
In the psoriasis studies, 1% (15/1373) of patients experienced serum sickness or acombination of arthralgia and/or myalgia with fever, and/or rash, usually early in thetreatment course. Of these patients, 6 required hospitalization due to fever, severe myalgia,arthralgia, swollen joints, and immobility.
Other Adverse Reactions
Safety data are available from 4779 adult patients treated with infliximab, including 1304with rheumatoid arthritis, 1106 with Crohn’s disease, 484 with ulcerative colitis, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 1373 with plaque psoriasis and 17 withother conditions. [For information on other adverse reactions in pediatric patients, seeAdverse Reactions (6.1)]. Adverse reactions reported in ≥ 5% of all patients with rheumatoidarthritis receiving 4 or more infusions are in Table 2. The types and frequencies of adversereactions observed were similar in rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis, plaque psoriasis and Crohn’s disease patients treated with infliximab except forabdominal pain, which occurred in 26% of patients with Crohn’s disease. In the Crohn’sdisease studies, there were insufficient numbers and duration of follow-up for patients whonever received infliximab to provide meaningful comparisons.
Table 2 Adverse reactions occurring in 5% or more of patients receiving 4 or moreinfusions for rheumatoid arthritis
Placebo Infliximab
(n = 350) (n = 1129)
Average weeks of follow-up 59 66
Gastrointestinal
Nausea 20% 21%
Abdominal pain 8% 12%
Diarrhea 12% 12%
Dyspepsia 7% 10%
Respiratory
Upper respiratory tract infection 25% 32%
Sinusitis 8% 14%
Pharyngitis 8% 12%
Coughing 8% 12%
Bronchitis 9% 10%
Skin and appendages disorders
Rash 5% 10%
Pruritus 2% 7%
Body as a whole-general disorders
Fatigue 7% 9%
Pain 7% 8%
Resistance mechanism disorders
Fever 4% 7%
Moniliasis 3% 5%
Central and peripheral nervous system disorders
Headache 14% 18%
Musculoskeletal system di |
