title: Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials.
abstract: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA.
  
  
  
  Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient's Assessment of Arthritis Pain (PAAP), Patient's Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
  
  
  
  In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24.
  
  
  
  In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.
authors.affiliation: Pfizer Inc, Groton, CT, USA. gene.wallenstein@pfizer.com.
authors.forename: Gene V
authors.initials: GV
authors.lastname: Wallenstein
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Keith S
authors.initials: KS
authors.lastname: Kanik
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Bethanie
authors.initials: B
authors.lastname: Wilkinson
authors.affiliation: Metroplex Clinical Research Center, Dallas, TX, USA.
authors.forename: Stanley
authors.initials: S
authors.lastname: Cohen
authors.affiliation: University of Genoa, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cutolo
authors.affiliation: Metroplex Clinical Research Center, Dallas, TX, USA.
authors.forename: Roy
authors.initials: RM
authors.lastname: Fleischmann
authors.affiliation: Stanford University, Stanford, CA, USA.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.affiliation: Hospital Clinico Universitario, Santiago de Compostela, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Gomez Reino
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: David
authors.initials: D
authors.lastname: Gruben
authors.affiliation: Albany Medical College, Albany, NY, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Kremer
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Sriram
authors.initials: S
authors.lastname: Krishnaswami
authors.affiliation: Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Eun Bong
authors.initials: EB
authors.lastname: Lee
authors.affiliation: Instituto Nacional de Ciencias Médicas y Nutrición-Salvador Zubirán, Mexico City, Mexico.
authors.forename: Virginia
authors.initials: V
authors.lastname: Pascual-Ramos
authors.affiliation: Stanford University, Stanford, CA, USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Samuel H
authors.initials: SH
authors.lastname: Zwillich
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D018771:Arthralgia / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D060467:Disease Resistance; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D053612:Janus Kinases / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D010880:Piperidines; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D053612:Janus Kinases