title: Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis.
abstract: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this study was to explore the safety and efficacy of open-label tofacitinib following blinded treatment with adalimumab or tofacitinib for moderate to severe RA.
  
  
  
  Analyses included patients treated with adalimumab 40 mg once every 2 weeks or tofacitinib 10 mg twice daily (BID) with background methotrexate (MTX) in a 12-month randomized study (NCT00853385), who subsequently received tofacitinib 10 mg BID (with/without background MTX) in an open-label extension (NCT00413699). Patients with treatment-related serious adverse events (AEs) and serious or recurrent infections in the index study were excluded from the extension study. Exposure-adjusted incidence rates of safety-related events were assessed in 3-month and 12-month periods in the year before and in the year after switching. Efficacy was assessed 3 months before, at the time of, and 3 months after switching.
  
  
  
  There were 233 (107 adalimumab to tofacitinib 10 mg BID, 126 blinded to open-label tofacitinib 10 mg BID) patients included in these analyses. Patients in both treatment sequences had similar incidence rates (per 100 patient-years) of discontinuation due to AEs, serious AEs, and serious infections in the year before and in the year after switching. Incidence rates of AEs were increased in the first 3 months after switching compared with the last 3 months before switching in both treatment groups. Switching from either blinded adalimumab or tofacitinib to open-label tofacitinib resulted in numerically higher incidence of responders for signs and symptoms of disease and improved physical function.
  
  
  
  Treatment can be directly switched from adalimumab to tofacitinib. A similar safety and efficacy profile was seen when patients received open-label tofacitinib after receiving either blinded adalimumab or tofacitinib.
  
  
  
  ClinicalTrials.gov Identifiers: NCT00853385 , registered 27 February 2009; NCT00413699 , registered 18 December 2006.
authors.affiliation: Division of Rheumatology, Stanford University, Palo Alto, CA, USA.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.affiliation: Unit for Clinical Therapy Research, Inflammatory Diseases, Karolinska Institute, Stockholm, Sweden.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Bethanie
authors.initials: B
authors.lastname: Wilkinson
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Lisy
authors.initials: L
authors.lastname: Wang
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Samuel H
authors.initials: SH
authors.lastname: Zwillich
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: David
authors.initials: D
authors.lastname: Gruben
authors.affiliation: Pfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA.
authors.forename: Pinaki
authors.initials: P
authors.lastname: Biswas
authors.affiliation: Pfizer Inc, Groton, CT, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Riese
authors.affiliation: Pfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA. Liza.Takiya@pfizer.com.
authors.forename: Liza
authors.initials: L
authors.lastname: Takiya
authors.affiliation: Pfizer Inc, 500 Arcola Drive, F5352, Collegeville, PA, 19426, USA.
authors.forename: Thomas V
authors.initials: TV
authors.lastname: Jones
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D057915:Drug Substitution; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D010880:Piperidines; D011743:Pyrimidines; D011758:Pyrroles; C479163:tofacitinib; D000068879:Adalimumab
keywords: Adalimumab; Drug switching; Efficacy; Rheumatoid arthritis; Safety; Tofacitinib