Table 3

Disease remission at 6 months in GP2017 switchers with SB5 as reference for overall switch cohort and stratified by indication, results of logistic regression analyses

Overall cohortP valueRAP valuePsAP valueAxSpAP value
OR (95% CI)OR (95% CI)OR (95% CI)OR (95% CI)
Main analysis n=1110n=401n=263n=446
 Unadjusted1.12 (0.88 to 1.42)0.3691.22 (0.78 to 1.88)0.3831.02 (0.57 to 1.79)0.9581.25 (0.85 to 1.86)0.261
 Age and gender adjusted1.14 (0.89 to 1.45)0.2941.23 (0.79 to 1.92)0.3521.32 (0.72 to 2.41)0.3731.21 (0.81 to 1.81)0.356
 Fully adjusted*1.72 (1.25 to 2.37)0.0011.81 (1.07 to 3.06)0.0271.79 (0.88 to 3.66)0.1081.87 (1.04 to 3.34)0.036
Sensitivity analysis S1† n=812n=242n=214n=356
 Unadjusted1.00 (0.75 to 1.32)0.9821.08 (0.61 to 1.91)0.8010.89 (0.46 to 1.70)0.7211.29 (0.84 to 1.98)0.252
 Age and gender adjusted1.03 (0.78 to 1.37)0.8191.06 (0.59 to 1.89)0.8441.06 (0.54 to 2.08)0.8631.22 (0.78 to 1.89)0.38
 Fully adjusted*1.59 (1.09 to 2.32)0.0161.65 (0.80 to 3.40)0.1731.78 (0.78 to 4.02)0.1671.77 (0.95 to 3.30)0.07
Sensitivity analysis S2‡ n=709n=261n=161n=287
 Unadjusted1.14 (0.84 to 1.56)0.3991.41 (0.78 to 2.56)0.2551.50 (0.64 to 3.51)0.3531.39 (0.86 to 2.23)0.179
 Age and gender adjusted1.16 (0.85 to 1.59)0.3511.43 (0.79 to 2.60)0.2412.05 (0.82 to 5.09)0.1211.31 (0.80 to 2.15)0.283
 Fully adjusted*1.87 (1.23 to 2.85)0.0031.77 (0.91 to 3.44)0.09NANA1.63 (0.81 to 3.26)0.169
Sensitivity analysis S4§ n=1110n=401n=263n=446
 Unadjusted0.92 (0.72 to 1.18)0.5310.88 (0.58 to 1.32)0.5270.63 (0.38 to 1.03)0.0631.25 (0.85 to 1.86)0.261
 Age and gender adjusted0.93 (0.73 to 1.19)0.5750.86 (0.57 to 1.31)0.4850.79 (0.47 to 1.34)0.3881.21 (0.81 to 1.81)0.356
 Fully adjusted*1.49 (1.07 to 2.08)0.0191.41 (0.81 to 2.46)0.221.34 (0.67 to 2.67)0.4081.87 (1.04 to 3.34)0.036

  • Disease remission defined as Disease Activity Score-28 <2.6 (RA and PsA) and Ankylosing Spondylitis Disease Activity Score <1.3 (AxSpA). Time-windows applied for data capture regarding disease activity at 6 months were +7 days to +365 days after switch date.

  • For patients with missing data on disease remission at 6 months, the following assumptions were made as part of an approximated intention-to-treat analysis: (1) patients, who had withdrawn treatment (0–6 months) due to lack of effect were classified as being not in remission, (2) patients, who had withdrawn (0–6 months) due to remission were classified as being in remission, (3) patients, who were still being treated but had >1 swollen joint at 6 months were classified as being not in remission, (4) patients who were still being treated, but had patient global score >30 mm were classified as being not in remission and (5) patients who still had missing data on disease remission were classified as being (a) excluded, with additional sensitivity analyses, (b) in remission (best case scenario) and (c) not in remission (worst case scenario). Analyses where the ‘rule of 5’ was not met are indicated with NA in the results.

  • *Adjusted for baseline age, gender, current smoking, indication (only for overall switch cohort), baseline disease remission, 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).

  • †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.

  • §S4: Similar to the main analysis except 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.