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Table 1 Adjusted mean change from baseline in PROs at weeks 16 (all patients) and 24 (non-EE responder analysis) in patients treated with abatacept or placebo and stratified by baseline CRP level or prior TNFi use

From: Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial

Subpopulation Week 16 (before EE) Week 24 (non-EE responders)
CRP > ULN Abatacept Placebo Adjusted mean difference (95% CI) Abatacept Placebo Adjusted mean difference (95% CI)
HAQ-DI −0.34 (0.05),*n = 139 −0.19 (0.05), n = 115 −0.15 (−0.28 to −0.02) −0.41 (0.07), n = 86 −0.23 (0.08), n = 59 −0.18 (−0.37 to 0.01)
SF-36 PCS 4.97 (0.70),*n = 139 2.50 (0.75), n = 112 2.47 (0.63 to 4.31) 6.41 (0.83), n = 86 4.04 (0.95), n = 58 2.37 (0.13 to 4.61)
SF-36 MCS 4.54 (0.86),*n = 139 1.39 (0.94), n = 112 3.14 (0.85 to 5.44) 4.05 (1.05), n = 86 2.71 (1.24), n = 58 1.34 (−1.54 to 4.22)
FACIT-F −5.19 (0.83),*n = 139 −2.81 (0.88), n = 116 −2.38 (−4.57 to −0.19) −6.44 (1.03), n = 87 −5.44 (1.21), n = 60 −1.00 (−3.81 to 1.80)
DLQI −2.72 (0.42),*n = 141 −1.48 (0.45), n = 116 −1.24 (−2.35 to −0.13) −2.74 (0.55),*n = 87 −0.42 (0.64), n = 60 −2.32 (−3.80 to −0.83)
CRP ≤ ULN Abatacept Placebo Adjusted mean difference (95% CI) Abatacept Placebo Adjusted mean difference (95% CI)
HAQ-DI −0.08 (0.06), n = 62 −0.08 (0.06), n = 70 0.01 (−0.14 to 0.15) −0.12 (0.08), n = 37 −0.08 (0.08), n = 39 −0.04 (−0.26 to 0.19)
SF-36 PCS 1.33 (0.91), n = 62 1.56 (0.88), n = 72 −0.23 (−2.63 to 2.18) 3.04 (1.03), n = 37 3.10 (1.04), n = 39 −0.06 (−2.88 to 2.77)
SF-36 MCS −1.95 (1.20), n = 62 0.85 (1.17), n = 72 −2.80 (−6.00 to 0.40) −0.69 (1.29), n = 37 1.67 (1.31), n = 39 −2.37 (−5.94 to 1.21)
FACIT-F −0.58 (1.03), n = 66 −2.47 (1.02), n = 78 1.89 (−0.86 to 4.63) −0.77 (1.24), n = 38 −3.22 (1.28), n = 39 2.45 (−0.99 to 5.89)
DLQI −1.28 (0.57), n = 63 −1.04 (0.56), n = 71 −0.24 (−1.77 to 1.28) −1.60 (0.72), n = 38 −0.92 (0.75), n = 38 −0.69 (−2.70 to 1.33)
TNFi-naïve Abatacept Placebo Adjusted mean difference (95% CI) Abatacept Placebo Adjusted mean difference (95% CI)
HAQ-DI −0.24 (0.06), n = 80 −0.15 (0.06), n = 75 −0.08 (−0.25 to 0.08) −0.29 (0.06), n = 50 −0.17 (0.07), n = 35 −0.12 (−0.30 to 0.06)
SF-36 PCS 3.63 (0.89), n = 82 2.05 (0.91), n = 78 1.58 (−0.79 to 3.95) 4.70 (0.97), n = 49 2.92 (1.08), n = 34 1.78 (−0.91 to 4.46)
SF-36 MCS 2.98 (1.06),* n = 82 −0.02 (1.08), n = 78 3.00 (0.19 to 5.81) 2.54 (1.17), n = 49 2.79 (1.38), n = 34 −0.25 (−3.60 to 3.10)
FACIT-F −4.08 (1.01), n = 81 −2.17 (1.02), n = 79 −1.91 (−4.57 to 0.76) −4.14 (1.21), n = 51 −4.65 (1.41), n = 35 0.51 (−0.29 to 3.93)
DLQI −1.87 (0.51), n = 83 −0.92 (0.52), n = 79 −0.95 (−2.31 to 0.41) −1.52 (0.67), n = 51 −0.23 (0.75), n = 34 −1.29 (−3.16 to 0.57)
TNFi-exposed Abatacept Placebo§ Adjusted mean difference (95% CI) Abatacept Placebo§ Adjusted mean difference (95% CI)
HAQ-DI −0.25 (0.05), n = 122 −0.13 (0.05), n = 112 −0.12 (−0.25 to 0.01) −0.35 (0.06), n = 74 −0.18 (0.07), n = 63 −0.16 (−0.33 to 0.00)
SF-36 PCS 3.50 (0.70), n = 120 1.68 (0.74), n = 108 1.82 (−0.02 to 3.66) 5.02 (0.86), n = 75 3.70 (0.93), n = 63 1.32 (−0.95 to 3.59)
SF-36 MCS 2.03 (0.94), n = 120 1.97 (0.99), n = 108 0.06 (−2.41 to 2.53) 2.46 (1.16), n = 75 2.37 (1.24), n = 63 0.09 (−2.95 to 3.13)
FACIT-F −3.34 (0.86), n = 121 −2.96 (0.89), n = 110 −0.39 (−2.64 to 1.86) −4.61 (1.09), n = 75 −4.13 (1.16), n = 64 −0.48 (−3.34 to 2.38)
DLQI −2.68 (0.45), n = 122 −1.61 (0.48), n = 110 −1.07 (−2.27 to 0.12) −2.76 (0.59),*n = 75 −0.71 (0.63), n = 64 −2.04 (−3.59 to −0.49)
  1. Data are adjusted mean change (SE) unless otherwise indicated. A positive change in SF-36 PCS and SF-36 MCS and a negative change in FACIT-F, HAQ-DI and DLQI corresponded to an improvement
  2. CI confidence interval, CRP C-reactive protein, DLQI Dermatology Life Quality Index, EE early escape, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue scale, HAQ-DI Health Assessment Questionnaire-Disability Index, MCS mental component summary, PCS physical component summary, PRO patient-reported outcome, SE standard error, SF-36 Short Form-36, TNFi tumour necrosis factor inhibitor, ULN upper limit of normal
  3. *95% CI of difference versus placebo did not cross 0
  4. At least 70% of the TNFi-exposed subpopulation were TNFi failures
  5. Prior TNFi use, n (%): 1 TNFi, 94 (44.1); 2 TNFi, 31 (14.6); ≥ 3 TNFi, 4 (1.9)
  6. §Prior TNFi use, n (%): 1 TNFi, 92 (43.6); 2 TNFi, 36 (17.1); ≥ 3 TNFi, 2 (0.9)