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Deutscher Rheumatologiekongress 2022, 50. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 36. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 32. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

31.08. - 03.09.2022, Berlin

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Add-on or withdrawal of methotrexate do not impact efficacy of IL12/23 inhibition in active PsA: Data from the multicenter investigator-initiated randomized placebo-controlled MUST trial

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  • Michaela Köhm - Rheumatology department, Goethe-University Frankfurt and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main
  • Tanja Rossmanith - Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main
  • Ann Christina Foldenauer - Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main
  • Herbert Kellner - Praxis Prof. Dr. Kellner, München
  • Uta Kiltz - Rheumazentrum Ruhrgebiet, Herne
  • Jürgen Rech - Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen
  • Gerd-Rüdiger Burmester - Charite Universitätsmedizin Berlin and DRFZ, Berlin, Berlin
  • David Kofler - Universitätsklinikum Köln, Med. Klinik I für Innere Medizin Immunologische Ambulanz, Köln
  • Jan Brandt-Jürgens - Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz, Berlin
  • Jürgen Braun - Rheumazentrum Ruhrgebiet, Herne
  • Stephanie Finzel - Division of Rheumotology and Clinical Immunology, University Medical Centre Freiburg, Freiburg im Breisgau
  • Raoul Bergner - Klinikum Ludwigshafen, Medical Clinic A Hematology and Oncology, Nephrology, Rheumatology, Internal Medicine and Infectious Disease (HIV), Ludwigshafen
  • Maren Sieburg - Rheumatologische Fachpraxis, Magdeburg
  • Peter Kästner - MVZ Ambulantes Rheumazentrum Erfurt, Praxis für Innere Medizin und Rheumatologie, Erfurt
  • Christin Jonetzko - Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main
  • Harald Burkhardt - Rheumatology department, Goethe-University Frankfurt and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main
  • Frank Behrens - Rheumatology department, Goethe-University Frankfurt and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. Deutscher Rheumatologiekongress 2022, 50. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 36. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 32. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Berlin, 31.08.-03.09.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. DocSpA.59

doi: 10.3205/22dgrh187, urn:nbn:de:0183-22dgrh1877

Veröffentlicht: 31. August 2022

© 2022 Köhm et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

Introduction: Methotrexate (MTX) is used as first-line DMARD-therapy in active psoriatic arthritis (PsA) according to local guidelines, but its value for a combination therapy with bDMARDs has remained unclear to date. Here we report the results of an investigator-initiated, randomized, placebo-controlled trial (IIT) in active PsA to clarify whether MTX increases the efficacy of IL12/23 inhibition with ustekinumab (UST) alone.

Methods: Out of 186 patients with active PsA (defined as TJC≥4, SJC≥4 [68/66 joint count] and DAS28≥3.2) screened, 173 were randomized to UST+MTX (new or ongoing) or UST+PBO. Patients were stratified according to previous MTX therapy. Demographic data and disease activity status (joint count [TJC/SJC], enthesitis [LEI], dactylitis count, PASI, BSA), QoL (EQ5D, DLQI) and function (HAQ) were compared between groups. The primary outcome, non-inferiority of DAS28-ESR at week 24 for UST monotherapy (UST+PBO) vs UST+MTX was assessed in concordance with a stratified van Elteren test with alpha=2.5% and tested by a non-inferiority margin of 12.5% according to the underlying stratified Mann-Whitney estimator (MWE).

Results: Baseline (BL) data were well-balanced between treatment groups (UST+MTX, n=87; UST+PBO, n=79) including sex (42.5% vs 40.5% female) and mean values for age (49.2 vs 47.2 years), BMI (29.4 vs 28.9 kg/m2), SJC (8 vs 8), TJC (12 vs 12), DAS28-CRP (4.6 vs 4.4), DAPSA (36.7 vs 34.9), PASI (2.8 vs 2.4), enthesitis (LEI >0: 50.57% vs 50.63%), and other domains. Minor BL differences were seen in dactylitis (24.1% vs 19.0%), BSA (2.9% vs 1.0%), and DLQI (8.6 vs 6.9). At week 24, mean DAS28-ESR decreased to 3.1 (SD 1.42) for UST+MTX vs 2.9 (SD 1.31) for UST+PBO with a stratified MWE for the treatment comparison of 0.5426 (95% CI 0.4545, 0.6307) demonstrating non-inferiority of UST+PBO.

Conclusion: This IIT shows that UST is an effective treatment for active PsA that works independently of MTX. The data indicate that the addition of MTX has no impact on the efficacy of UST for all important outcomes: arthritis, enthesitis, dactylitis, skin, QoL and function. Thus, there is no evidence that there is no need to either add MTX or maintain ongoing MTX when starting UST.

Disclosures: None declared.

Figure 1 [Fig. 1]