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Table 2 Change from baseline in patient-reported outcome scores at weeks 24 and 52

From: Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial

Patient-reported outcome

(n) Least square mean ± standard error

 

Week 24

Week 52

 

Placebo + MTX (n = 398)

Sarilumab 150 mg q2w + MTX (n = 400)

Sarilumab 200 mg q2w + MTX (n = 399)

Placebo + MTX (n = 398)

Sarilumab 150 mg q2w + MTX (n = 400)

Sarilumab 200 mg q2w + MTX (n = 399)

PtGA

(253) -15.7 ± 1.4

(312) -28.3 ± 1.3***

(319) -32.9 ± 1.3***

(196) -20.3 ± 1.5

(272) -31.7 ± 1.4***

(272) -32.8 ± 1.4***

Pain VAS

(253) -15.4 ± 1.4

(313) -28.5 ± 1.4***

(321) -31.8 ± 1.3***

(196) -19.3 ± 1.6

(273) -32.7 ± 1.4***

(272) -33.1 ± 1.4***

HAQ-DI

(253) -0.32 ± 0.03

(313) -0.56 ± 0.03***

(316) -0.57 ± 0.03***

(195) -0.27 ± 0.04

(272) -0.62 ± 0.03***

(270) -0.63 ± 0.03***

FACIT-F

(252) 5.8 ± 0.5

(311) 8.6 ± 0.5***

(320) 9.2 ± 0.5***

(195) 6.1 ± 0.5

(270) 9.1 ± 0.5***

(271) 9.2 ± 0.5***

SF-36 component scores

PCS

(246) 5.2 ± 0.5

(299) 8.0 ± 0.5***

(309) 8.4 ± 0.5***

(187) 5.6 ± 0.6

(257) 9.2 ± 0.5***

(263) 9.1 ± 0.5***

MCS

(246) 3.9 ± 0.6

(299) 5.7 ± 0.6*

(309) 8.2 ± 0.6***

(187) 5.5 ± 0.7

(257) 7.1 ± 0.6

(263) 8.4 ± 0.6**

SF-36 domain scores

Physical functioning

(253) 11.9 ± 1.5

(312) 17.5 ± 1.3*

(316) 18.2 ± 1.3**

(195) 13.9 ± 1.6

(272) 21.3 ± 1.4**

(269) 21.3 ± 1.4**

Role physical

(252) 12.8 ± 1.4

(309) 18.7 ± 1.3**

(318) 20.4 ± 1.3***

(194) 15.5 ± 1.5

(266) 20.7 ± 1.3*

(271) 22.5 ± 1.3**

Body pain

(250) 15.3 ± 1.3

(312) 25.3 ± 1.2***

(318) 27.6 ± 1.2***

(192) 16.7 ± 1.5

(272) 28.1 ± 1.3***

(269) 28.0 ± 1.3***

General health

(248) 7.6 ± 1.1

(307) 12.80 ± 1.0**

(319) 15.2 ± 1.0***

(191) 10.5 ± 1.3

(269) 14.5 ± 1.1*

(271) 15.9 ± 1.1**

Vitality

(251) 9.8 ± 1.2

(308) 13.9 ± 1.1*

(320) 18.0 ± 1.0***

(194) 11.4 ± 1.3

(268) 17.5 ± 1.1**

(271) 17.7 ± 1.1**

Social functioning

(252) 9.8 ± 1.4

(312) 17.3 ± 1.2***

(320) 20.8 ± 1.2***

(195) 11.9 ± 1.6

(272) 20.4 ± 1.4***

(271) 20.8 ± 1.4***

Role emotional

(252) 10.3 ± 1.5

(308) 14.6 ± 1.4*

(318) 17.9 ± 1.4***

(193) 14.8 ± 1.6

(264) 17.3 ± 1.4

(269) 21.4 ± 1.4*

Mental health

(251) 7.4 ± 1.1

(308) 10.4 ± 1.0*

(320) 14.0 ± 1.0***

(194) 9.8 ± 1.2

(268) 13.0 ± 1.1*

(271) 14.3 ± 1.1*

  1. q2w every 2 weeks, FACIT-F functional assessment of chronic illness therapy-fatigue scale, HAQ-DI health assessment questionnaire disability index, SF-36 36-item Short Form Health Survey-Version 2, MCS mental component summary, MTX methotrexate, PCS physical component summary, PtGA patient global assessment of disease activity, VAS visual analog scale. *p < 0.05, **p < 0.001, and ***p < 0.0001 versus placebo + MTX