Table 1

Overview of trials included in the integrated evobrutinib safety analyses

Trial identifierPhaseIndicationPatients randomised, nTreatmentDuration, weeksEligibilityReference
NCT02975349IIMS267Placebo (Week 0–24) + evobrutinib 25 mg QD (Week 25–48) (n=54)
Evobrutinib 25 mg QD (n=52)
Evobrutinib 75 mg QD (n=53)
Evobrutinib 75 mg BID (n=54)
Dimethyl fumarate (n=54, open-label reference arm; patients in this treatment arm were not included in the integrated safety analysis)
  • Adults 18–65 years

  • Relapsing–remitting or secondary progressive MS with superimposed relapses

  • EDSS score ≤6

Montalban et al23
NCT03233230IIbRA390Placebo (n=97)
Evobrutinib 25 mg QD (n=98)
Evobrutinib 75 mg QD (n=96)
Evobrutinib 50 mg BID (n=99)
  • Adults 18–75 years

  • Confirmed diagnosis of RA ≥6 months duration prior to screening

  • Active moderate to severe RA at screening and randomisation (≥6 swollen joints and ≥6 tender joints)

  • An hsCRP ≥5.0 mg/L (≥0.50 mg/dL) from two samples collected during screening

  • Patients had received methotrexate treatment 7.5–25 mg/week for ≥16 weeks at stable dose for ≥8 weeks

Peterfy et al25
NCT02975336IISLE469*Placebo (n=117)
Evobrutinib 25 mg QD (n=118)
Evobrutinib 75 mg QD (n=117)
Evobrutinib 50 mg BID (n=117)
  • Adults 18–75 years

  • Diagnosed with SLE by either the SLICC criteria, or at least four of the ACR criteria ≥6 months prior to screening

  • At screening, patients must have a SLEDAI-2K score ≥6, including a SLEDAI-2K clinical score ≥4, and be auto-antibody positive (a positive test result for anti-double-stranded DNA antibody and/or antinuclear antibody (human epithelial cell-2 antinuclear antibody ≥1:80) and/or anti-Smith antibody)

  • Vaccination against Streptococcus pneumoniae and influenza was required, as per local guidelines

Wallace et al26
  • *The primary analysis from the SLE trial was conducted before all patients had completed the trial. Therefore, the integrated analysis reports the safety analysis set that included all patients (n=480).

  • ACR, American College of Rheumatology; BID, twice daily; EDSS, Expanded Disability Status Scale; hsCRP, high-sensitivity C-reactive protein; MS, multiple sclerosis; QD, once daily; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index-2000; SLICC, Systemic Lupus International Collaborating Clinics.