. 2023 Feb 8;159(3):289–298. doi: 10.1001/jamadermatol.2022.6325

Table 4. Pooled Incidence and RR of Outpatient Infections During Off-label Years (2009-2015) Compared With Postapproval Years (2016-2021), After Propensity Score Decile Stratification.

Outcome	Ustekinumab vs etanercept		Ustekinumab vs methotrexate		Etanercept vs methotrexate
Outcome	Ustekinumab^a	Etanercept	Ustekinumab^a	Methotrexate	Etanercept	Methotrexate
Off-label years (2009-2015): outpatient infection^b
No. of patients	50	443	53	724	313	685
No. of person-years	20	185	22	297	131	281
No. of events	7	78	8	128	54	120
Rate per 1000 person-years	350.0	421.6	363.6	431.0	412.2	427.1
RR (95% CI)	0.83 (0.38-1.80)	1 [Reference]	0.84 (0.41-1.72)	1 [Reference]	0.97 (0.70-1.33)	1 [Reference]
Postapproval years (2016-2021): outpatient infection
No. of patients	329	336	341	456	358	636
No. of person-years	133	134	139	185	148	260
No. of events	32	61	38	81	50	102
Rate per 1000 person-years	240.6	455.2	273.4	437.8	337.8	392.3
RR (95% CI)	0.53 (0.34-0.81)	1 [Reference]	0.62 (0.42-0.92)	1 [Reference]	0.93 (0.64-1.36)	1 [Reference]

Abbreviation: RR, rate ratio.

^{^a}

Included ustekinumab users who contributed to 1 or more pairwise comparisons.

^{^b}

Outpatient infection was defined as an outpatient physician visit for a bacterial or viral infection with a filled prescription for an antibiotic or antiviral agent within 3 days after the diagnosis. The years 2009 to 2015 correspond to off-label use of these medications in pediatric patients. The years 2016 to 2021 correspond to the years after approval of biologic agents etanercept and ustekinumab for pediatric patients.