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Baricitinib Treatment Yielded Similar Infection Risk as Other Therapies for RA
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In patients with active rheumatoid arthritis, treatment with baricitinib appeared to yield an incidence of serious infection events comparable to that incurred in placebo-treated patients, according to a study presented at the EULAR Annual Congress in Madrid.
“The main finding is that the infection rate was similar to what we have seen with other [Janus kinase] JAK inhibitors, as well as biologics,” researcher Kevin L. Winthrop, MD, assistant professor at Oregon Health and Science University told Healio Rheumatology. “There is an increased risk of serious infection, but it is similar to that of other types of therapy used in [rheumatoid arthritis] RA.”
In the analysis, researchers assessed 3,492 patients with active RA treated with baricitinib across eight completed studies (four Phase 3, three Phase 2 and one Phase 1) and one ongoing long-term extension (LTE) study. An all baricitinib (ALL BARI) analysis set included patients exposed to any dose of the drug, with exposure up to 5 years; the BARI vs. placebo (PBO) comparison was based on six studies with BARI 4-mg once daily (QD) treatment arms and PBO arms up to week 24. Four studies were used to determine base response assessment, with BARI 2-mg QD and 4-mg QD arms up to week 24.
The researchers found that in six trials, during the first 24 weeks of treatment, the BARI 4-mg group had a serious incident event (SIE) incident rate of 3.8 per 100 patient-years. The placebo arms had an SIE incident rate of 4.2 per 100 patient-years. Moreover, the study found that in a set of four clinical trials, the BARI 2-mg group had an SIE incident rate of 4.2 per 100-patient years and the 4-mg BARI group had an SIE incident rate of 5.7 per 100 patient years vs. 5.1 per 100 patient-years in the placebo group.
The most prevalent SIEs documented in the ALL BARI RA set (n=3,492; 5,133 patient-years of exposure) were pneumonia, herpes zoster, urinary tract infection and cellulitis (all less than 1%), and two deaths occurred in patients with SIEs (incidence rate 0.04 per 100 patient-years). Between weeks 0 and 24, analysis of the six studies showed similar rates of SIEs in the BAR 4-mg (n=997; 417 per 100 patient-years) and placebo groups (n=1,070; 403 patient-years of exposure). The four-study set showed similar rates of SIEs between the BARI 2-mg group (n=479; 192 patient years of exposure) and the BARI 4-mg (n=479; 194 patient years of exposure) dose groups.
The following were identified as key risk factors in the development of SIEs: concomitant use of corticosteroids; previous use of biologics; BMI outside the normal range; Asian region of study enrollment; and advancing age.
Analyses of the LTE study demonstrated continued efficacy and benefit at 2 years. One analysis found that at 2 years, patients treated with BARI throughout the entire 2 years had significantly less progression of structural joint damage vs. those treated with placebo or methotrexate. In a second analysis, researchers reported that in patients treated with BARI for up to 3 years, the percentage of patients with low disease activity at 24 weeks in different treatment groups across trials remained stable or increased up to 3 years.
“It is reassuring that with baricitinib, the instance and types of infection seen and the risk factors for infection are similar to those we have seen with other RA therapies.” Winthrop said. – by Jennifer Byrne
For more information:
Winthrop KL, et al. Abstract #OP0248. Presented at: EULAR Annual Congress; July 14-17, 2017; Madrid.
Disclosure: Winthrop reports he receives grant/research support from Pfizer and Bristol-Myers Squibb, and consultancy for Pfizer, UCB, AbbVie, Eli Lilly, Amgen and Bristol-Myers Squibb.