Table 1.
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Safety profile related to study agents using IL-6 inhibition in SLE

Study agentDose studiedNumber of study participantsBackground therapy
Any AEaSAEaInfectionaDeatha
Prednisone (% of patients)Immunosuppressants and antimalarials (% of patients)
Tocilizumab [47]Tocilizumab (2, 4, 8 mg/kg)1694%No; HCQ: 75%100%25% (n = 4); all in 8 mg/kg dose81%0%
Sirukumab [48]bPlacebo560%HCQ: 40%; MTX: 20%80% (n = 4)20% (n = 1)20% (n = 1)0%
Sirukumab, 10 mg/kg/2 wk1080%HCQ: 80%; MTX: 0%90% (n = 9)20% (n = 2)70% (n = 7)0%
Sirukumab [49]
Placebo4100%MMF: 75%; AZA: 25%100% (n = 4)0%50% (n = 4)0%
Sirukumab, 10 mg/kg/4 wk2195%MMF: 71%; AZA: 29%100% (n = 21)47.6% (n = 10)85.7% (n = 18)0%
PF-04236921 [50]c
Placebo4569%Immunosuppressants: 44%; antimalarials: 76%Non-infectious AE: 75.6%; infectious AE: 44.4%22.3% (n = 11)44.4% (n = 20)0%
PF-04236921, 10 mg4771%Immunosuppressants: 40%; antimalarials: 78%Non-infectious AE: 75.6%; infectious AE: 42.2%8.8% (n = 4)42.2% (n = 19)2.2% (n = 1)
PF-04236921, 50 mg4677%Immunosuppressants: 45%; antimalarials : 72%non-infectious AE: 68.1%; infectious AE: 48.9%10.6% (n = 5)48.9% (n = 23)0%
PF-04236921, 200 mg4574%Immunosuppressants: 50%; antimalarials : 57%non-infectious AE: 67.4%; infectious AE: 41.3%28.4% (n = 13)41.3% (n = 19)6.5% (n = 3)
Study agentDose studiedNumber of study participantsBackground therapy
Any AEaSAEaInfectionaDeatha
Prednisone (% of patients)Immunosuppressants and antimalarials (% of patients)
Tocilizumab [47]Tocilizumab (2, 4, 8 mg/kg)1694%No; HCQ: 75%100%25% (n = 4); all in 8 mg/kg dose81%0%
Sirukumab [48]bPlacebo560%HCQ: 40%; MTX: 20%80% (n = 4)20% (n = 1)20% (n = 1)0%
Sirukumab, 10 mg/kg/2 wk1080%HCQ: 80%; MTX: 0%90% (n = 9)20% (n = 2)70% (n = 7)0%
Sirukumab [49]
Placebo4100%MMF: 75%; AZA: 25%100% (n = 4)0%50% (n = 4)0%
Sirukumab, 10 mg/kg/4 wk2195%MMF: 71%; AZA: 29%100% (n = 21)47.6% (n = 10)85.7% (n = 18)0%
PF-04236921 [50]c
Placebo4569%Immunosuppressants: 44%; antimalarials: 76%Non-infectious AE: 75.6%; infectious AE: 44.4%22.3% (n = 11)44.4% (n = 20)0%
PF-04236921, 10 mg4771%Immunosuppressants: 40%; antimalarials: 78%Non-infectious AE: 75.6%; infectious AE: 42.2%8.8% (n = 4)42.2% (n = 19)2.2% (n = 1)
PF-04236921, 50 mg4677%Immunosuppressants: 45%; antimalarials : 72%non-infectious AE: 68.1%; infectious AE: 48.9%10.6% (n = 5)48.9% (n = 23)0%
PF-04236921, 200 mg4574%Immunosuppressants: 50%; antimalarials : 57%non-infectious AE: 67.4%; infectious AE: 41.3%28.4% (n = 13)41.3% (n = 19)6.5% (n = 3)
a

Data presented as percentage of participants. As some studies were small, number of events reported as ‘n’ in parenthesis.

b

Part A of the study had patients with cutaneous lupus erythematous. Data from Part A not included here.

c

Non-infectious and infectious adverse effects were reported separately.

AE: adverse event; SAE: serious adverse event.

Table 1.
Open in new tab

Safety profile related to study agents using IL-6 inhibition in SLE

Study agentDose studiedNumber of study participantsBackground therapy
Any AEaSAEaInfectionaDeatha
Prednisone (% of patients)Immunosuppressants and antimalarials (% of patients)
Tocilizumab [47]Tocilizumab (2, 4, 8 mg/kg)1694%No; HCQ: 75%100%25% (n = 4); all in 8 mg/kg dose81%0%
Sirukumab [48]bPlacebo560%HCQ: 40%; MTX: 20%80% (n = 4)20% (n = 1)20% (n = 1)0%
Sirukumab, 10 mg/kg/2 wk1080%HCQ: 80%; MTX: 0%90% (n = 9)20% (n = 2)70% (n = 7)0%
Sirukumab [49]
Placebo4100%MMF: 75%; AZA: 25%100% (n = 4)0%50% (n = 4)0%
Sirukumab, 10 mg/kg/4 wk2195%MMF: 71%; AZA: 29%100% (n = 21)47.6% (n = 10)85.7% (n = 18)0%
PF-04236921 [50]c
Placebo4569%Immunosuppressants: 44%; antimalarials: 76%Non-infectious AE: 75.6%; infectious AE: 44.4%22.3% (n = 11)44.4% (n = 20)0%
PF-04236921, 10 mg4771%Immunosuppressants: 40%; antimalarials: 78%Non-infectious AE: 75.6%; infectious AE: 42.2%8.8% (n = 4)42.2% (n = 19)2.2% (n = 1)
PF-04236921, 50 mg4677%Immunosuppressants: 45%; antimalarials : 72%non-infectious AE: 68.1%; infectious AE: 48.9%10.6% (n = 5)48.9% (n = 23)0%
PF-04236921, 200 mg4574%Immunosuppressants: 50%; antimalarials : 57%non-infectious AE: 67.4%; infectious AE: 41.3%28.4% (n = 13)41.3% (n = 19)6.5% (n = 3)
Study agentDose studiedNumber of study participantsBackground therapy
Any AEaSAEaInfectionaDeatha
Prednisone (% of patients)Immunosuppressants and antimalarials (% of patients)
Tocilizumab [47]Tocilizumab (2, 4, 8 mg/kg)1694%No; HCQ: 75%100%25% (n = 4); all in 8 mg/kg dose81%0%
Sirukumab [48]bPlacebo560%HCQ: 40%; MTX: 20%80% (n = 4)20% (n = 1)20% (n = 1)0%
Sirukumab, 10 mg/kg/2 wk1080%HCQ: 80%; MTX: 0%90% (n = 9)20% (n = 2)70% (n = 7)0%
Sirukumab [49]
Placebo4100%MMF: 75%; AZA: 25%100% (n = 4)0%50% (n = 4)0%
Sirukumab, 10 mg/kg/4 wk2195%MMF: 71%; AZA: 29%100% (n = 21)47.6% (n = 10)85.7% (n = 18)0%
PF-04236921 [50]c
Placebo4569%Immunosuppressants: 44%; antimalarials: 76%Non-infectious AE: 75.6%; infectious AE: 44.4%22.3% (n = 11)44.4% (n = 20)0%
PF-04236921, 10 mg4771%Immunosuppressants: 40%; antimalarials: 78%Non-infectious AE: 75.6%; infectious AE: 42.2%8.8% (n = 4)42.2% (n = 19)2.2% (n = 1)
PF-04236921, 50 mg4677%Immunosuppressants: 45%; antimalarials : 72%non-infectious AE: 68.1%; infectious AE: 48.9%10.6% (n = 5)48.9% (n = 23)0%
PF-04236921, 200 mg4574%Immunosuppressants: 50%; antimalarials : 57%non-infectious AE: 67.4%; infectious AE: 41.3%28.4% (n = 13)41.3% (n = 19)6.5% (n = 3)
a

Data presented as percentage of participants. As some studies were small, number of events reported as ‘n’ in parenthesis.

b

Part A of the study had patients with cutaneous lupus erythematous. Data from Part A not included here.

c

Non-infectious and infectious adverse effects were reported separately.

AE: adverse event; SAE: serious adverse event.

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