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Abstract Number: 1528

Unique Changes in Hemoglobin with Sarilumab Versus Adalimumab Are Independent of Better Disease Control in Patients with Rheumatoid Arthritis (RA)

Gerd R. Burmester1, Owen Hagino2, Qunming Dong3, Marina Stanislav4, Antonio Gomez-Centeno5, Carlo Selmi6, Tom W.J. Huizinga7, Erin Mangan8, Cem Gabay9 and Mark C. Genovese10, 1Charité – University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, 2Sanofi Genzyme, Bridgewater, NJ, 3Sanofi, Bridgewater, NJ, 4Scientific Research Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation, 5Corporació Sanitària Parc Taulí, Barcelona, Spain, 6Rheumatology and Clinical Immunology Unit, Humanitas Research Hospital, Rozzano (MI), Italy, 7Leiden University Medical Center, Leiden, Netherlands, 8Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 9University Hospitals of Geneva, Geneva, Switzerland, 10Stanford University Medical Center, Palo Alto, CA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Anemia, Biologic drugs, IL-6, rheumatoid arthritis (RA) and tumor necrosis factor (TNF)

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Session Information

Date: Monday, October 22, 2018

Title: Rheumatoid Arthritis – Treatments Poster II: PROs, Safety and Comorbidity

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

Anemia (WHO criteria: Hemoglobin [Hb] levels <12.0 g/dL [females] or <13.0 g/dL [males]) is a common finding associated with increased joint inflammation in patients with RA and changes in Hb levels are associated with changes in disease activity; therefore, the influence of sarilumab on Hb is of clinical interest. This post hoc analysis assessed potential relationships between Hb, disease activity, and physical function in the adalimumab-controlled MONARCH study (NCT02332590).

Methods:

In the MONARCH study, adult patients intolerant of, inappropriate for, or inadequate responders to methotrexate were randomized to SC sarilumab 200 mg q2w or adalimumab 40 mg q2w monotherapy for 24 wks. The primary endpoint was change from baseline in DAS28-ESR at Wk 24.  Post hoc analyses were conducted on changes in Hb using a mixed-effects model for repeated measures assuming an unstructured covariance structure: Model = baseline, treatment, region, visit, and treatment-by-visit interaction. Missing data were not imputed. Proportion of anemic patients was summarized by visit. Relationships between Hb and efficacy measures were explored.

Results:

At baseline, mean Hb levels were 13.0 g/dL in sarilumab (n=184) and adalimumab (n=185) groups and 25% of patients had anemia (WHO criteria). For the primary endpoint of change from baseline in DAS28‑ESR, sarilumab was superior to adalimumab (−3.28 vs −2.20; P<0.0001). Compared with adalimumab, at Wks 12 and 24, sarilumab resulted in larger increases in Hb (Wk 24 least squares mean change from baseline 0.591 vs 0.075 g/dL; least squares mean difference 0.516 [95% CI: 0.319, 0.713]; nominal P<0.001 [Figure]).  By Wk 24, 16.2% of adalimumab-treated and 10.9% of sarilumab-treated patients were classified with anemia.  In the adalimumab group, at Wk 24, correlations between increases in Hb and decreases in markers of disease activity and physical disability were noted (Figure). In the sarilumab group, increases in Hb and decreases in disease activity and physical disability were not correlated. Most common adverse events were neutropenia and injection-site reactions (sarilumab) and headache and worsening RA (adalimumab). There were three adverse event reports of anemia (none were serious or led to treatment discontinuation): 1 report of microcytic anemia (adalimumab) and 2 of worsening of anemia (sarilumab). Decreases from baseline in hepcidin and ferritin were similar for sarilumab and adalimumab at Wk 2, but not measured thereafter.

Conclusion:

Sarilumab treatment was associated with larger increases in Hb and reductions in patients with anemia than adalimumab, unrelated to its better control of RA disease activity.  Sarilumab appears to be a good treatment choice in patients with RA and anemia.

Acknowledgements

Study funding and medical writing support (Sarah Feeny, Adelphi Communications) provided by Sanofi and Regeneron Pharmaceuticals, Inc.


Disclosure: G. R. Burmester, AbbVie, Pfizer, UCB, Roche, 2,AbbVie, Lilly, MSD, Pfizer, Sanofi, Roche, UCB, 5, 8; O. Hagino, Sanofi Genzyme, 1, 3; Q. Dong, Sanofi Genzyme, 1, 3; M. Stanislav, R-Pharm, 5; A. Gomez-Centeno, Boehringer Ingelheim, Celltrion, Galapagos-Gilead, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, YL Biologics, 2,Abbvie, Biogen, BMS, Celgene, Gebro, Hospira, Lilly, MSD, Pfizer, Roche, Rubio, Sandoz, Sanofi, 5,Abbvie, BMS, Gebro, Janssen, Lilly, Menarini, MSD, Pfizer, Roche, Rubio, UCB, Sanofi, 8; C. Selmi, AbbVie, Janssen, MSD, Novartis, Pfizer, 2,AbbVie, Alfa-Sigma, Biogen, Bristol-Myrs Squibb, Celgene, Eli-Lilly, GlaxoSmithKline, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, 5, 8; T. W. J. Huizinga, Abblynx, Roche and Sanofi, 2, 5; E. Mangan, Regeneron Pharmaceuticals Inc., 1, 3; C. Gabay, AB2 Bio, Pfizer and Roche, 2,AB2 Bio, AbbVie, Bristol Myers Squibb, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB, 5, 8; M. C. Genovese, Sanofi/Genzyme, Genentech/Roche, RPharm, 2, 5.

To cite this abstract in AMA style:

Burmester GR, Hagino O, Dong Q, Stanislav M, Gomez-Centeno A, Selmi C, Huizinga TWJ, Mangan E, Gabay C, Genovese MC. Unique Changes in Hemoglobin with Sarilumab Versus Adalimumab Are Independent of Better Disease Control in Patients with Rheumatoid Arthritis (RA) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/unique-changes-in-hemoglobin-with-sarilumab-versus-adalimumab-are-independent-of-better-disease-control-in-patients-with-rheumatoid-arthritis-ra/. Accessed .
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