Artikel
Impact of Methotrexate on disease pattern in active psoriatic arthritis patients eligible for a randomized clinical trial with Ustekinumab (UST): Comparative baseline data from multicentre investigator-initiated MUST trial
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Autoren
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Tanja Rossmanith
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD
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Michaela Köhm
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD; Rheumatology Department, Goethe-University Hospital Frankfurt
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Uta Kiltz
- Rheumazentrum Ruhrgebiet, Herne
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Jürgen Rech
- Rheumatology Department, University Erlangen
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Gerd Rüdiger Burmester
- Department for Rheumatology and Immunology, Universitätsmedizin Charité
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Herbert Kellner
- Rheumapraxis, München
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Anita Bulczak-Schadendorf
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD
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Ann Christina Foldenauer
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD
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Harald Burkhardt
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD; Rheumatology Department, Goethe-University Hospital Frankfurt
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Frank Behrens
- Fraunhofer IME, Translational Medicine & Pharmacology TMP; Fraunhofer Cluster of Excellence Immune-mediated Diseases CIMD; Rheumatology Department, Goethe-University Hospital Frankfurt
| Veröffentlicht: | 9. September 2020 |
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Gliederung
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Introduction: Methotrexate (MTX) as csDMARD is initiated as first-line therapy (after NSAID) in active psoriatic arthritis (PsA). Randomized clinical trials mostly require treatment failure or intolerance of csDMARD/MTX therapy before initiation of a biological treatment. We designed an investigator-initiated (IIT) randomised blinded study comparing PsA patients starting open label UST combined with blinded MTX or placebo (PLC) stratified regarding previous MTX therapy (MTX-pre-treated – group A or MTX-naïve – group B).
Methods: 186 patients with active PsA were screened for eligibility at Baseline (BL) whereof 173 starting open label UST were randomised to receive MTX or PLC. Demographics, PsA and PsO disease activity, previous medication, quality of life (QoL) and function (using DLQI, HAQ) and subject’s pain assessment (VAS-pain) were collected.
Results: Preliminary blinded data export comprised all documented and released data for BL until January 2020 - in total 154 randomized patients (78 in A, 76 in B). BL characteristics were well balanced in age and BMI. More patients were male in B. Median disease duration in A was 2,9 y but only 0,3 y in B. More patients in A had failed previous biological therapy due to tolerability or ineffectiveness.
Mean values for DAS28 was 4,5 for both groups, SGA, PGA were comparable as well as mean LEI. Mean number of digits with dactylitis were slightly higher in B.
PASI and mtNAPSI were higher in B (7,2 vs. 3,3 and 5,0 vs. 3,0). In DLQI in A more patients experienced “no effect” (22% vs. 7%) whereas more patients in B see a “moderate” to “extreme large effect” of their skin disease on QoL.
Conclusion: Our results give important information about comparability of patient on MTX or without MTX eligible for trial with biologicals. Despite a comparable disease activity, skin diseases activity was more pronounced in MTX naïve patients. Nevertheless, number of dactylitis affected digits was higher in MTX naïve patients whereas impact on enthesitis seems to be neglectable.
Disclosures: All authors: Grant/research support from Janssen.
