title: Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational Study.
abstract: OBJECTIVE
  To examine the influence of concomitant methotrexate (MTX) with adalimumab (ADA) on outcomes in patients with psoriatic arthritis (PsA) using data from an observational study of ADA.
  
  
  METHODS
  Data from a German noninterventional study of patients with PsA starting treatment with ADA were analyzed retrospectively for effects of concomitant MTX on key outcomes, including Disease Activity Score-28 joints, tender and swollen joint counts, skin assessments, and safety. Patients were categorized into those with symptoms of axial involvement and those with no symptoms of axial involvement as judged by the examining clinician.
  
  
  RESULTS
  A total of 1455 patients met the study criteria, 296 with axial involvement (ADA monotherapy = 165; plus MTX = 131) and 1159 with no axial involvement (ADA monotherapy = 658; plus MTX = 501). ADA, alone or combined with MTX, resulted in strong and comparable reductions in disease activity measures in patients with and those without axial disease over 24 months of therapy. In multiple regression analyses, concomitant MTX did not affect joint or skin outcomes in either the group with axial manifestations or the group without axial disease. Neither adverse event rates nor withdrawal rates were significantly influenced by concomitant MTX.
  
  
  CONCLUSIONS
  ADA is an effective treatment option for patients with PsA with or without axial involvement. Compared with ADA monotherapy, the use of concomitant MTX with ADA does not improve articular or skin outcomes in patients with PsA regardless of axial symptoms.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01111240.
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Frank
authors.initials: F
authors.lastname: Behrens
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Michaela
authors.initials: M
authors.lastname: Koehm
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Uta
authors.initials: U
authors.lastname: Arndt
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Bianca M
authors.initials: BM
authors.lastname: Wittig
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Gerd
authors.initials: G
authors.lastname: Greger
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Diamant
authors.initials: D
authors.lastname: Thaçi
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Eva
authors.initials: E
authors.lastname: Scharbatke
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Tony
authors.affiliation: From the Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main; Rheumapraxis Hofheim, Hofheim; AbbVie Deutschland GmbH and Co. KG, Wiesbaden; Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck; and Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg, Würzburg, Germany.F. Behrens, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; M. Koehm, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; H. Burkhardt, MD, Division of Rheumatology, University Hospital Frankfurt, Goethe University, and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP; U. Arndt, MD, Rheumapraxis Hofheim; B.M. Wittig, MD, AbbVie Deutschland GmbH and Co. KG; G. Greger, PhD, AbbVie Deutschland GmbH and Co. KG; D. Thaçi, MD, Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus; E. Scharbatke, MD; H.P. Tony, MD, Schwerpunkt Rheumatologie/Klinische Immunologie Medizinische Klinik und Poliklinik II, Universität Würzburg. Harald.Burkhardt@kgu.de.
authors.forename: Harald
authors.initials: H
authors.lastname: Burkhardt
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab; D008727:Methotrexate
keywords: ADALIMUMAB; ANTI-TUMOR NECROSIS FACTOR THERAPY; CONCOMITANT THERAPY; METHOTREXATE; PSORIATIC ARTHRITIS