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Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis : patient-reported outcomes from a phase III trial . OBJECTIVE To assess patient-reported outcomes ( PROs ) for tofacitinib , an oral JAK inhibitor for the treatment of rheumatoid arthritis ( RA ) , in a 6-month , phase III , randomized controlled trial . METHODS Patients ages ≥18 years with active RA with an inadequate response to ≥1 tumor necrosis factor inhibitor ( TNFi ) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily , or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3 . PROs measured at month 3 included patient global assessment of disease activity ( PtGA ) , pain , Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , Medical Outcomes Study ( MOS ) Short Form 36 Health Survey version 2 ( SF-36v2 ; acute ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , and MOS Sleep Scale . RESULTS Patients received tofacitinib 5 mg ( n = 133 ) or 10 mg ( n = 134 ) or placebo advanced to tofacitinib 5 mg ( n = 66 ) or 10 mg ( n = 66 ) . HAQ DI ( reported previously ) , PtGA ( P < 0.0001 ) , and SF-36v2 physical and mental component summary ( P < 0.05 ) scores were improved for both tofacitinib doses versus placebo . Furthermore , improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib-treated patients versus placebo for PtGA ( P < 0.05 ) , pain ( P < 0.0001 ) , HAQ DI ( P < 0.05 ) , SF-36v2 physical and mental component summary scores ( P < 0.05 ) , and FACIT-F ( P < 0.001 for 5 mg twice daily ) . No statistical differences were observed in the MOS Sleep Scale . CONCLUSION Tofacitinib treatment resulted in significant , clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi .
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Intervention_Pharmacological
Tofacitinib with methotrexate
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Outcome_Pain
included patient global assessment of disease activity ( PtGA )
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Outcome_Pain
pain
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Outcome_Pain
Health Assessment Questionnaire ( HAQ ) disability index ( DI )
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Outcome_Pain
Medical Outcomes Study ( MOS ) Short Form 36 Health Survey version 2 ( SF-36v2 ; acute )
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Outcome_Pain
Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F )
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Outcome_Pain
MOS Sleep Scale
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Outcome_Other
66
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Outcome_Physical
HAQ DI ( reported previously ) , PtGA ( P < 0.0001 ) , and SF-36v2 physical and mental component summary ( P < 0.05 ) scores were improved
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Outcome_Other
for PtGA
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Outcome_Physical
0.0001 ) , HAQ
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Outcome_Mental
0.05 ) , SF-36v2 physical and mental component summary scores
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Outcome_Other
and FACIT-F
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Outcome_Other
daily
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Outcome_Other
No statistical differences
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Outcome_Mental
the MOS Sleep Scale
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Participant_Condition
patients with active rheumatoid arthritis
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Participant_Age
Patients ages ≥18 years