Abstract | BACKGROUND: METHODS: In this post hoc analysis, serum samples were analysed at baseline and prespecified post-treatment timepoints up to week 24 in adults with moderate-to-severe active rheumatoid arthritis intolerant of or inadequate responders to methotrexate from the MONARCH trial (NCT02332590). RESULTS: Greater reductions in C-reactive protein (CRP; - 94.0% vs. -24.0%), serum amyloid A (SAA; - 83.2% vs. -17.4%), total receptor activator of nuclear factor-κB ligand (RANKL; - 18.3% vs. 10.5%) and lipoprotein (a) (- 41.0% vs. -2.8%) were observed at week 24 with sarilumab vs. adalimumab, respectively (adjusted p < 0.0001). Greater increases in procollagen type 1 N-terminal propeptide (P1NP) were observed with sarilumab vs. adalimumab at week 24 (22.8% vs. 6.2%, p = 0.027). Patients with high baseline SAA, CRP and matrix metalloproteinase-3 (MMP-3) were more likely to achieve clinical efficacy, including American College of Rheumatology 20% improvement criteria and Disease Activity Score (28 joints)-CRP < 3.2, and report improvements in patient-reported outcomes, including Health Assessment Questionnaire-Disability Index and pain visual analogue scale, with sarilumab than adalimumab. CONCLUSION:
Sarilumab was associated with greater positive effects on bone remodelling and decreases in biomarkers of the acute-phase response, synovial inflammation and cardiovascular risk vs. adalimumab. High baseline concentrations of SAA, CRP and MMP-3 are predictive of clinical and patient-reported outcome responses to sarilumab treatment and prospective validation is warranted to confirm these results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02332590. Registered on 5 January 2015.
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Authors | Cem Gabay, Gerd R Burmester, Vibeke Strand, Jérôme Msihid, Moshe Zilberstein, Toshio Kimura, Hubert van Hoogstraten, Susan H Boklage, Jonathan Sadeh, Neil M H Graham, Anita Boyapati |
Journal | Arthritis research & therapy
(Arthritis Res Ther)
Vol. 22
Issue 1
Pg. 70
(04 07 2020)
ISSN: 1478-6362 [Electronic] England |
PMID | 32264972
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Biomarkers
- C-Reactive Protein
- Matrix Metalloproteinase 3
- Adalimumab
- sarilumab
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Topics |
- Adalimumab
(therapeutic use)
- Adult
- Aged
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Arthritis, Rheumatoid
(blood, drug therapy, pathology)
- Biomarkers
(blood)
- Bone Remodeling
(drug effects)
- C-Reactive Protein
(analysis)
- Cardiovascular Diseases
(blood, prevention & control)
- Double-Blind Method
- Female
- Humans
- Male
- Matrix Metalloproteinase 3
(blood)
- Middle Aged
- Prospective Studies
- Treatment Outcome
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