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Iguratimod in combination with methotrexate in active rheumatoid arthritis

Therapeutic effects

Iguratimod in Kombination mit Methotrexat bei aktiver rheumatoider Arthritis

Therapieeffekte

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Abstract

Background

Rheumatoid arthritis (RA) is a potentially destructive disease that may have a profound impact on patients’ function and quality of life. RA therapy is still a challenge for rheumatologists; however, new antirheumatic drugs may be a treatment option for disease-modifying antirheumatic drug (DMARD)-experienced patients with active RA.

Objectives

The present study is a prospective trial that aims to investigate the effects of therapy with iguratimod plus methotrexate (MTX) in comparison with iguratimod or MTX monotherapy in DMARD-experienced adult patients with active RA.

Methods

A total of 131 patients (24 men, 107 women, mean age 46.63 ± 10.61 years) with a history of being treated with traditional DMARDs were investigated. In all, 44 patients were treated with iguratimod (25 mg, twice daily, orally) plus MTX (a weekly dose of 10 mg, orally), 38 patients received iguratimod (25 mg, twice daily, orally), or 49 patients received MTX (weekly dose of 10 mg, orally) for 24 weeks.

Results

A therapeutic effect with iguratimod was observed between 4 and 10 weeks after treatment initiation and was effective even in patients who had a poor response to previous treatment with DMARDs. The combination of iguratimod with MTX was superior to iguratimod or MTX monotherapy.

Conclusion

The data imply that iguratimod is a welcome addition to the small-molecule drug therapy for DMARD-experienced patients with active RA. Iguratimod (alone or in combination with MTX) is an emerging option for the treatment of DMARD-experienced adult patients with active RA who have had an inadequate response to or are intolerant of other DMARDs.

Zusammenfassung

Hintergrund

Die rheumatoide Arthritis (RA) ist eine potenziell destruktive Erkrankung, die erheblichen Einfluss auf Funktionalität und Lebensqualität haben kann. Ihre Behandlung stellt nach wie vor eine Herausforderung dar, doch neue Antirheumatika sind möglicherweise eine Therapieoption für Patienten mit aktiver RA, die erfahren sind im Umgang mit DMARDs („disease-modifying antirheumatic drugs”) bzw. Basistherapeutika.

Ziele

Die vorgestellte Studie ist eine prospektive Untersuchung zur Erforschung der Therapieeffekte der Kombination Iguratimod plus Methotrexat (MTX) im Vergleich zu einer Iguratimod- oder MTX-Monotherapie bei erwachsenen, DMARD-erfahrenen RA-Patienten.

Methoden

Insgesamt 131 Patienten (24 Männer, 107 Frauen, Durchschnittsalter 46,63 ± 10,61 Jahre) mit einer traditionellen DMARD-Behandlung in der Anamnese wurden in die Studie eingeschlossen. Mit Iguratimod (25 mg, 2-mal täglich, oral) plus MTX (eine wöchentliche Dosis von 10 mg, oral) wurden 44 Patienten behandelt, mit Iguratimod (25 mg, 2-mal täglich, oral) 38 und mit MTX (wöchentliche Dosis, 10 mg, oral) 49, jeweils über 24 Wochen.

Ergebnisse

Zwischen 4 und 10 Wochen nach Beginn der Behandlung mit Iguratimod wurde eine therapeutische Wirkung beobachtet, Iguratimod war sogar effektiv bei Patienten, die zuvor auf DMARDs kaum angesprochen hatten. Die Iguratimod-MTX-Kombination erwies sich als den jeweiligen Monotherapien überlegen.

Schlussfolgerung

Die Daten implizieren, dass Iguratimod für DMARD-erfahrene Patienten mit aktiver RA eine willkommene Ergänzung zur Therapie mit kleinmolekularen Substanzen ist. Iguratimod (allein oder in Kombination mit MTX) kristallisiert sich heraus als Option zur Behandlung DMARD-erfahrener Patienten mit aktiver RA, die auf DMARDs nicht ausreichend ansprechen oder Unverträglichkeiten aufweisen.

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Compliance with ethical guidelines

Conflict of interest. Z. Xia, J. Lyu, N. Hou, L. Song, X. Li, H. Lui state that there are no conflicts of interest.

All studies on humans described in the present manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current, revised form). Informed consent was obtained from all patients included in studies.

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Authors and Affiliations

  1. Department of Rheumatology, Shandong University Qilu Hospital, 107 Wenhua Xi Road, 250012, Jinan, Shandong Province , China

    Z. Xia, N. Hou, L. Song, X. Li & H. Liu

  2. Department of Internal Medicine, Dezhou People’s Hospital, Dezhou, China

    J. Lyu

Authors
  1. Z. Xia
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  2. J. Lyu
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  3. N. Hou
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  4. L. Song
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  5. X. Li
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  6. H. Liu
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Corresponding author

Correspondence to H. Liu.

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Xia, Z., Lyu, J., Hou, N. et al. Iguratimod in combination with methotrexate in active rheumatoid arthritis. Z Rheumatol 75, 828–833 (2016). https://doi.org/10.1007/s00393-015-1641-y

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  • DOI: https://doi.org/10.1007/s00393-015-1641-y

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