Table 2

One-year comparative treatment withdrawal in GP2017 versus SB5 for overall switch cohort and stratified by indication, results of crude and adjusted Cox regression analyses

	Overall cohort	P value	RA	P value	PsA	P value	AxSpA	P value
	HR (95% CI)	P value	HR (95% CI)	P value	HR (95% CI)	P value	HR (95% CI)	P value
Main analysis	n=1318		n=467		n=321		n=530
Unadjusted	0.69 (0.49 to 0.97)	0.034	0.50 (0.28 to 0.91)	0.023	1.00 (0.49 to 2.03)	0.991	0.74 (0.42 to 1.32)	0.305
Age and gender adjusted	0.66 (0.47 to 0.94)	0.02	0.50 (0.28 to 0.90)	0.021	0.97 (0.46 to 2.02)	0.927	0.75 (0.42 to 1.33)	0.317
Fully adjusted*	0.60 (0.42 to 0.86)	0.005	0.48 (0.26 to 0.88)	0.019	NA	NA	0.68 (0.38 to 1.22)	0.187
Sensitivity analysis S1†	n=982		n=283		n=274		n=425
Unadjusted	0.66 (0.43 to 1.02)	0.06	0.61 (0.28 to 1.33)	0.208	1.14 (0.48 to 2.71)	0.761	0.51 (0.25 to 1.05)	0.068
Age and gender adjusted	0.64 (0.41 to 0.99)	0.046	0.61 (0.28 to 1.34)	0.209	1.08 (0.44 to 2.63)	0.857	0.48 (0.23 to 0.99)	0.048
Fully adjusted*	0.59 (0.37 to 0.92)	0.021	NA	NA	NA	NA	NA	NA
Sensitivity analysis S2:‡	n=825		n=295		n=191		n=339
Unadjusted	0.68 (0.43 to 1.08)	0.103	0.65 (0.31 to 1.35)	0.24	1.10 (0.39 to 3.08)	0.846	0.58 (0.26 to 1.30)	0.176
Age and gender adjusted	0.69 (0.43 to 1.09)	0.111	0.66 (0.32 to 1.37)	0.256	1.16 (0.40 to 3.34)	0.764	0.56 (0.25 to 1.28)	0.163
Fully adjusted*	0.63 (0.40 to 1.02)	0.058	NA	NA	NA	NA	NA	NA
Sensitivity analysis S3§	n=1318		n=467		n=321		n=530
Unadjusted	0.73 (0.50 to 1.08)	0.117	0.58 (0.30 to 1.14)	0.111	1.02 (0.45 to 2.31)	0.954	0.74 (0.40 to 1.38)	0.335
Age and gender adjusted	0.70 (0.48 to 1.04)	0.074	0.57 (0.29 to 1.12)	0.098	1.02 (0.44 to 2.37)	0.952	0.73 (0.39 to 1.38)	0.336
Fully adjusted*	0.64 (0.43 to 0.94)	0.024	NA	NA	NA	NA	NA	NA
Sensitivity analysis S4¶	n=1318		n=467		n=321		n=530
Unadjusted	0.69 (0.49 to 0.97)	0.034	0.50 (0.28 to 0.91)	0.023	1.00 (0.49 to 2.03)	0.991	0.74 (0.42 to 1.32)	0.305
Age and gender adjusted	0.66 (0.47 to 0.94)	0.02	0.50 (0.28 to 0.90)	0.021	0.97 (0.46 to 2.02)	0.927	0.75 (0.42 to 1.33)	0.317
Fully adjusted*	0.59 (0.41 to 0.84)	0.004	0.47 (0.26 to 0.86)	0.016	NA	NA	0.68 (0.38 to 1.22)	0.187

*Adjusted for baseline age, gender, current smoking, indication (only for overall switch cohort), baseline disease remission (Disease Activity Score-28/Ankylosing Spondylitis Disease Activity Score), PASS, number of previous biological disease-modifying antirheumatic drugs (bDMARDs), treatment duration for originator adalimumab treatment, number of comorbidities (0 and ≥1). For patients with RA: Also baseline concomitant methotrexate (MTX). NA: Analyses where assumptions of proportional hazards or the ‘rule of 5’ were not met (see methods for details).
†S1: Randomised clinical trial inclusion and exclusion criteria: inclusion of patients with no more than one prior bDMARD treatment apart from originator adalimumab. Exclusion of patients >75 years, prior malignancy, >2 comorbidities and patients with RA not receiving concomitant MTX.
‡S2: Restricted to patients, who scored PASS=yes at baseline.
§S3: Only discontinuation due to lack of effect and/or adverse events was considered an event.
¶S4: Similar to the main analysis except baseline disease remission defined by Clinical Disease Activity Index <2.9 (RA and PsA).
AxSpA, axial spondyloarthritis; PASS, Patient Acceptable Symptom State; ; PsA, psoriatic arthritis; RA, rheumatoid arthritis.