Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

binomial distribution

Not adjusted for multiplicity with interim and final analyses

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.

Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.