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document
Application of the Itch Severity Score in patients with moderate-to-severe plaque psoriasis : Clinically important difference and responder analyses . The Itch Severity Score ( ISS ) , a 0-10 numeric rating scale , was used to assess pruritus due to psoriasis in a Phase 2 b trial of tofacitinib , a novel oral Janus kinase inhibitor . 197 patients with moderate-to-severe plaque psoriasis were randomized to tofacitinib 2 , 5 or 15 mg twice daily , or placebo . The ISS was recorded daily from baseline to week 2 and at study visits . Following good and recommended research practice , we performed analyses to examine the clinically important differences ( CID ) ( between-group difference or within-group difference ) and clinically important responders ( CIR ) ( within-patient change ) for the ISS . The CID and CIR were defined using Patient Global Assessment of psoriasis as an anchor and were estimated with a longitudinal model . A CID on the ISS was 1.64 and , by day 10 , the mean changes from baseline in ISS values for the tofacitinib doses ( placebo-adjusted ) exceeded CID . A CIR on the ISS was a 30 % improvement from baseline and , at week 12 , 87.2 % to 100 % of patients receiving tofacitinib reached ≥30 % improvement versus 29.4 % of patients receiving placebo ( p < 0.0001 ) . Overall , the CID and CIR analyses play vital roles in the interpretation of the treatment effects measured by ISS .
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Intervention_Pharmacological
tofacitinib
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Intervention_Pharmacological
tofacitinib
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Outcome_Other
baseline in ISS values
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Participant_Condition
patients with moderate-to-severe plaque psoriasis :
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Participant_Condition
inhibitor
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Participant_Sample-size
197 patients
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Participant_Condition
plaque psoriasis