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Response to: ‘Correspondence on ‘EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update’ by Fallon et al
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  1. Xenofon Baraliakos1,
  2. Laure Gossec2,3,
  3. Iain McInnes4,
  4. Andreas Kerschbaumer5,
  5. Maarten de Wit6,
  6. Maxime Dougados7,
  7. Jette Primdahl8,9,
  8. Désirée van der Heijde10,11,
  9. Josef S Smolen5
  1. 1Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Nordrhein-Westfalen, Germany
  2. 2Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Universite, Paris, France
  3. 3APHP, Rheumatology Department, Hopital Universitaire Pitie Salpetriere, Paris, France
  4. 4Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  5. 5Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Wien, Austria
  6. 6EULAR past Vice President representing People with Arthritis/Rheumatism in Europe (PARE), Zurich, Switzerland
  7. 7Department of Rheumatology - Hôpital Cochin. Assistance Publique, Hôpitaux de Paris INSERM (U1153): Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité, Université de Paris, Paris, France
  8. 8Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  9. 9Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark
  10. 10Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  11. 11Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  1. Correspondence to Dr Xenofon Baraliakos, Rheumazentrum Ruhrgebiet, Herne 44649, Germany; baraliakos{at}me.com

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We thank Fallon and Jones1 for their correspondence on the European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis (PsA) and their comments on the clarity of the specific recommendation regarding the use of Janus kinase inhibitors (JAKi) in the management of PsA,2 which was based on the associated systematic literature research (SLR).3

We appreciate the support of the authors to provide as much clarification to the wording of our recommendations as possible, since these are the currently most up-to-date literature for the current and future treatment of patients with PsA.

In their remarks, Fallon and Jones refer to recommendation 7 and especially the wording on the safety signals of tofacitinib related to events of venous thromboembolism (VTE, including pulmonary embolism (PE) and deep vein thrombosis (DVT)). Indeed, the conclusions of the available literature, so far, are as they describe: in an interim analysis of a study in patients with rheumatoid arthritis (RA) aged ≥50 years and with ≥1 cardiovascular risk factor, the incidence of PE events has been found to be statistically significantly increased in the group treated with tofacitinib 10 mg two times per day (a dose not approved in PsA or RA), when compared with tumour necrosis factor inhibitors (TNFi); however, while not statistically significantly different from the control arm, the data of the 5 mg arm still show a numerical increase in thromboembolic events and thus are right in between control and 10 mg arms. Similarly, the HR for DVT was 1.7 and 3-fold increased for PE compared with control, as Fallon and Jones show in their table. While no data on patients with PsA with cardiovascular risk factors exist, the task force felt that it was important to make the readers aware of these risks, even if primarily coming from RA. Indeed, the warning by the regulators also does not exempt PsA from the risks. Importantly, recommendation 7 is not only referring to the comparison of JAKi with TNFi but also to the use of JAKi in PsA in general.

Fallon and Jones also comment on the sentence comparing the efficacy of tofacitinib and adalimumab on skin psoriasis in the text accompanying recommendation 7. As they mention, the OPAL Broaden data were fully presented in the SLR.2 However, EULAR recommendations are not solely based on evidence but include experts’ opinion and the discussions among the experts are reflected in the text accompanying the recommendations, as is the case here. Of note, the text clearly said that tofacitinib ‘may’ have ‘numerically lower efficacy in skin psoriasis’ and not ‘has lower efficacy’, reflecting the various positions within the expert committee.

Finally, we fully agree with the remark that it is important for the readers to remember that the Summary of Product Characteristics updates related to VTE are relevant for the treatment of patients with any condition for which tofacitinib is indicated, including patients with RA or PsA.

References

Footnotes

  • Handling editor David S Pisetsky

  • Contributors XB and JSS drafted the text. The other authors reviewed the text and commented. All authors approved the final version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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