Table 2. Outcome of Absolute PASI of 2 or Lower at 12 Months for Secukinumab and Ustekinumab^a .

Data source and missing outcome analysis method	CLEAR trial NRIb	Present BADBIR study
		CCA (n = 265 PS matched; n = 549 PS weighted)	NRI	LOCF (n = 559 PS matched; n = 1106 PS weighted)	IPCW	MI
PS-matched analysis (n = 622)
Estimated proportion on secukinumab achieving PASI ≤2, % (95% CI)	74.9	59.8 (31.5 to 75.6)	24.7 (19.9 to 29.5)	68.6 (63.2 to 74.1)	60.3 (51.1 to 69.5)	59.6 (51.8 to 67.4)
Estimated proportion on ustekinumab achieving PASI ≤2, % (95% CI)	60.6	40.4 (21.8 to 64.2)	17.5 (13.0 to 22.0)	54.7 (48.4 to 61.0)	42.0 (32.7 to 51.3)	42.7 (32.3 to 53.0)
RR (95% CI)	1.24 (1.11 to 1.37)	1.55 (1.19 to 2.01)	1.45 (1.04 to 2.03)	1.26 (1.10 to 1.45)	1.50 (1.14 to 1.96)	1.44 (1.07 to 1.94)
Standardized difference between CLEAR and BADBIR studies for RRc	NA	0.048	0.028	0.009	0.040	0.030
RD, % (95% CI)	14.3 (7.2 to 21.1)	19.5 (0.1 to 31.6)	7.2 (0.4 to 13.9)	14.0 (5.9 to 22.1)	18.3 (5.5 to 31.1)	16.9 (3.3 to 30.6)
Standardized difference between CLEAR and BADBIR studies for RDc	NA	0.024	−0.047	−0.003	0.018	0.011
PS-weighted analysis (n = 1231)
Estimated proportion on secukinumab achieving PASI ≤2, % (95% CI)	74.9	57.4 (48.3 to 66.4)	23.4 (18.5 to 28.2)	67.7 (62.0 to 73.4)	58.2 (48.5 to 67.9)	57.8 (48.5 to 67.1)
Estimated proportion on ustekinumab achieving PASI ≤2, % (95% CI)	60.6	45.5 (40.4 to 50.6)	20.4 (17.6 to 23.2)	58.6 (55.0 to 62.2)	45.9 (40.7 to 51.1)	44.7 (39.5 to 49.9)
RR (95% CI)	1.24 (1.11 to 1.37)	1.28 (1.06 to 1.55)	1.16 (0.91 to 1.48)	1.16 (1.04 to 1.29)	1.29 (1.06 to 1.58)	1.30 (1.04 to 1.62)
Standardized difference between CLEAR and BADBIR studies for RRc	NA	0.012	−0.016	−0.030	0.013	0.013
RD, % (95% CI)	14.3 (7.2 to 21.1)	11.9 (1.6 to 22.1)	2.9 (−2.6 to 8.5)	9.1 (2.4 to 15.8)	12.3 (1.4 to 23.2)	13.1 (1.3 to 24.9)
Standardized difference between CLEAR and BADBIR studies for RDc	NA	−0.012	−0.081	−0.034	−0.010	−0.006
Regulatory agreementd	NA	Yes	Yes (matched); No (weighted)	Yes	Yes	Yes
Estimate agreemente	NA	Yes (weighted); No (matched)	RR: yes (weighted); no (matched) RD: yes (matched); no (weighted)	Yes	RR: yes (weighted); no (matched) RD: yes	RR: yes (weighted); No (matched) RD: yes

Abbreviations: BADBIR, British Association of Dermatologists Biologics and Immunomodulators Register; CCA, complete case analysis; IPCW, inverse probability of censoring weighting; LOCF, last observation carried forward; MI, multiple imputation; NA, not applicable; NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; PS, propensity score; RCT, randomized clinical trial; RD, risk difference; RR, risk ratio.

^aRR and RD were calculated using MedCalc.net.

^bNumbers from the PASI 90 nonresponder imputation outcome at week 52 in the CLEAR study.^7,8

^cStandardized difference was calculated according to the methods in Franklin et al.⁶

^dIndicates whether the study replicates the direction and statistical significance of the CLEAR study^7,8 finding.

^eIndicates whether the study treatment effect is within the 95% CI of the treatment effect estimate from the CLEAR study.^7,8