14 16 There were no reports of demyelination, tuberculosis or malignancy, and there were no statistically significant differences in the incidence of serious AEs, serious infections, opportunistic infections or lupus-like reactions between adalimumab+MTX patients versus MTX alone patients.
There were no significant differences in the risk of serious and non-serious adverse events between groups (Table 3).
There were no significant group differences in the occurrence of serious adverse events between the duloxetine treatment groups and placebo and none of the serious adverse events were determined to be due to treatment with duloxetine.
There were no notable differences in the types of serious TEAEs between treatment groups, and no dose-related trends (the incidence of serious TEAEs was 3.1% for placebo, 6.5% for ESL 800 mg, and 1.4% for ESL 1,200 mg).
There were no statistically significant differences in the incidence of serious adverse events, and no seizures on LY2140023.
There were no differences in the number of serious adverse events (multiple organ dysfunction, heart arrest, shock, etc).
27 It was found that there were no significant differences in the occurrence of serious adverse events.
No differences in the occurrence of serious adverse events were noted and one patient in the placebo group had a colectomy during the intervention period.
There were no significant differences in the rates of serious adverse events (P=0.40), hospitalization (P=0.51), death (P=0.72), or major cardiovascular events.
Collectively, the incidence rates, risk ratio, and risk difference estimates for approved doses of biologic DMARDs do not indicate any significant differences in the risk of serious infections with tofacitinib compared with TNFi and biologic DMARDs in DMARD-IR patients.
