Table 1.

Overview of trials included in the integrated evobrutinib safety analyses

Trial identifier	Phase	Indication	Patients randomised, n	Treatment	Duration, weeks	Eligibility	Reference
NCT02975349	II	MS	267	Placebo (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)	48	Adults 18–65 years Relapsing–remitting or secondary progressive MS with superimposed relapses EDSS score ≤6	Montalban et al 23
NCT03233230	IIb	RA	390	Placebo (n=97) Evobrutinib 25 mg QD (n=98) Evobrutinib 75 mg QD (n=96) Evobrutinib 50 mg BID (n=99)	12	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 al 25
NCT02975336	II	SLE	469*	Placebo (n=117) Evobrutinib 25 mg QD (n=118) Evobrutinib 75 mg QD (n=117) Evobrutinib 50 mg BID (n=117)	52	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 al 26

*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.