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Sarilumab monotherapy vs sarilumab and methotrexate combination therapy in patients with rheumatoid arthritis.
Burmester, Gerd R; Bykerk, Vivian P; Buch, Maya H; Tanaka, Yoshiya; Kameda, Hideto; Praestgaard, Amy; van Hoogstraten, Hubert; Fernandez-Nebro, Antonio; Huizinga, Thomas.
Afiliação
  • Burmester GR; Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
  • Bykerk VP; Department of Rheumatology, Inflammatory Arthritis Center, Hospital for Special Surgery, New York, NY, USA.
  • Buch MH; Division of Musculoskeletal & Dermatological Sciences, Centre for Musculoskeletal Research, Faculty of Biology, Medicine & Health, University of Manchester.
  • Tanaka Y; NIHR Manchester Biomedical Research Centre, Manchester, UK.
  • Kameda H; The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
  • Praestgaard A; Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.
  • van Hoogstraten H; Department of Biostatistics, Sanofi, Cambridge, MA.
  • Fernandez-Nebro A; Department of, Global Medical Affairs, Sanofi, Bridgewater, NJ, USA.
  • Huizinga T; Department of Rheumatology, UGC Rheumatology, Institute of Biomedical Research in Malaga (IBIMA), Regional University Hospital of Malaga, University of Málaga, Málaga, Spain.
Rheumatology (Oxford) ; 61(6): 2596-2602, 2022 05 30.
Article em En | MEDLINE | ID: mdl-34508594
ABSTRACT

OBJECTIVE:

Sarilumab, as monotherapy or in combination with conventional synthetic DMARDs, such as MTX, has demonstrated improvement in clinical outcomes in patients with RA. The primary objective of this post hoc analysis was to compare the efficacy of sarilumab (200 mg every 2 weeks) monotherapy (MONARCH study) with that of sarilumab and MTX combination therapy (MOBILITY study) at week 24.

METHODS:

The endpoints assessed were mean change from baseline in the Clinical Disease Activity Index (CDAI), 28-joint Disease Activity using CRP (DAS28-CRP), CRP, haemoglobin (Hb), pain visual analogue scale (VAS) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Least square (LS) mean change from baseline (95% CI) at week 24 for all endpoints was compared between the treatment arms for adjusted comparisons.

RESULTS:

This analysis included 184 patients on sarilumab monotherapy and 399 patients on sarilumab plus MTX. Differences (P < 0.05) were observed in ethnicity, region, body mass index group, rheumatoid factor, anti-cyclic citrullinated peptide antibodies, swollen joint count, CRP, CDAI and oral glucocorticoid use between these treatment groups. After adjusting for these differences in a mixed-effect model repeated measure, LS mean change from baseline for all assessments was similar between the treatment groups with overlapping CIs CDAI, -28.79 vs -26.21; DAS28-CRP, -2.95 vs -2.81; CRP, -18.31 vs -16.46; Hb, 6.59 vs 8.09; Pain VAS, -33.62 vs -31.66; FACIT-Fatigue, 9.90 vs 10.24.

CONCLUSION:

This analysis demonstrated that the efficacy of sarilumab monotherapy was similar to that of sarilumab and MTX combination therapy.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Artrite Reumatoide / Antirreumáticos Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Revista: Rheumatology (Oxford) Assunto da revista: REUMATOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Artrite Reumatoide / Antirreumáticos Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Revista: Rheumatology (Oxford) Assunto da revista: REUMATOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Alemanha