ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1214

Association Between Changes in C-reactive Protein at Week 12 and Patient-Reported Outcomes at Week 24 with Sarilumab Therapy Across Three Pivotal Phase 3 Studies

John Tesser1, Grace Wright2, Vibeke Strand3, Jeffrey Kaine4, Karina Maslova5, Gregory St John6, Kerri Ford5, Amy Praestgaard5 and Ernest Choy7, 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2Association of Women in Rheumatology, New York, NY, 3Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 4Independent Rheumatology Consultant, Sapphire, NC, 5Sanofi, Cambridge, MA, 6Regeneron Pharmaceuticals Inc, Tarrytown, NY, 7CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Sunday, November 8, 2020

Title: RA – Treatments Poster III: PROs, Biomarkers, Systemic Inflammation & Radiographs

Session Type: Poster Session C

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

Background/Purpose: Evaluation of response to RA therapy at 12 weeks after initiation is recommended in treatment guidelines. CRP response after 12 weeks of therapy may indicate favorable subsequent improvement in patient-reported outcomes (PROs). Here, we describe the association between CRP response to sarilumab at Week 12 and PRO improvements at Week 24, using data from 3 pivotal studies.

Methods: The analysis included patients with RA who took part in MOBILITY (NCT01061736), TARGET (NCT01709578), or MONARCH (NCT02332590) and were treated with sarilumab 200 mg every 2 weeks (q2w) or adalimumab 40 mg q2w (MONARCH only). Patients who achieved a CRP response at Week 12 (defined as serum concentration ≤3 mg/L) were evaluated for PROs at Week 24. Response for PROs was defined as an improvement from baseline in visual analog scale score of ≥10 mm for pain, sleep, and morning stiffness, and an improvement of ≥4 points for the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score. Odds ratios (ORs) and 95% confidence intervals (CIs) were generated for the likelihood of achieving PRO responses at Week 24, based on patients’ achievement of CRP response at Week 12.

Results: Data for pain and fatigue were available in all 3 trials, for morning stiffness in TARGET and MONARCH only, and for sleep in MOBILITY only. After 12 weeks of treatment with sarilumab 200 mg every 2 weeks, CRP ≤3 mg/L was attained in 74% (137/184), 78% (311/399), and 80% (148/184) of patients from TARGET, MOBILITY, and MONARCH, respectively; in MONARCH, treatment with adalimumab 40 mg q2w was associated with CRP response in 35% (64/185) of patients. Across all 3 trials and all 4 PROs assessed, attainment of CRP ≤3 mg/L at Week 12 was associated with a higher proportion of PRO responders at Week 24 (Figure). These data suggest higher odds of achieving Week 24 PRO response in sarilumab-treated patients who did versus those who did not attain CRP ≤3 mg/L at Week 12 (Table). In MONARCH, sarilumab-treated patients who attained CRP ≤3 mg/L at Week 12 had numerically higher odds of achieving Week 24 PRO response than their adalimumab-treated counterparts (Table).

Conclusion: This post hoc analysis suggests that, in patients with moderate to severe RA treated with sarilumab 200 mg q2w or adalimumab 40 mg q2w, attainment of a CRP level ≤3 mg/L at Week 12 could predict improvements in pain, sleep, morning stiffness, or fatigue at Week 24.

Figure

Table

Disclosure: J. Tesser, Janssen, 1, 2, 3, Abbvie, 1, 2, 3, Sun Pharma, 1, 2, 3, Novartis, 1, 2, Lilly, 1, 2, 3, BMS, 1, 2, 3, Pfizer, 1, 2, 3, Amgen, 1; G. Wright, Exagen, 5, 8, AbbVie, 5, 8, Amgen, 5, 8, Bristol-Myers Squibb, 5, 8, Eli Lilly and Company, 5, 8, Myriad Autoimmune, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Regeneron Pharmaceuticals, Inc., 5, 8, Sanofi Genzyme, 5, 8, UCB, 5, 8; V. Strand, AbbVie, 5, Amgen, 5, Celltrion, 5, Janssen, 5, Merck, 5, Novartis, 5, Regeneron, 5, Sanofi, 5, UCB, 5, Genentech/Roche, 5, GSK, 5, Pfizer, 5, Bayer, 5, Bristol-Myers Squibb, 5, Boehringer Ingelheim, 5, Galapagos, 5, Lilly, 5, Gilead, 5, Samsung, 5, Servier, 5, Setpoint, 5, Arena, 5, AstraZeneca, 5, Horizon, 5, Ichnos, 5, Inmedix, 5, Sandoz, 5; J. Kaine, Eli Lilly, 8, Merck, 8, Sanofi, 8, Regeneron, 8; K. Maslova, Sanofi, 1, 3; G. St John, Regeneron, 3, Intercept Pharmaceuticals, Inc, 3, 4; K. Ford, Sanofi Genzyme, 1, 2; A. Praestgaard, Sanofi, 3; E. Choy, Abbvie, 2, 8, Amgen, 2, 8, AstraZeneca, 2, 8, Biogen, 2, 8, Bio-Cancer, 2, 8, Boehringer Ingelheim, 2, 8, Bristol-Myers Squibb, 2, 8, Celgene, 2, 8, Chugai Pharma, 2, 8, Eli Lilly, 2, 8, Ferring Pharmaceuticals, 2, 8, GlaxoSmithKline, 2, 8, Janssen, 2, 8, Novartis, 2, 8, Novimmune, 2, 8, ObsEva, 2, 8, Pfizer, 2, 8, R-Pharm, 2, 8, Roche, 2, 8, SynAct Pharma, 2, 8, Tonix, 2, 8, UCB, 2, 8, Synovate, 2, 8, Sanofi, 2, 8, Regeneron, 2, 8, Napp, 2, 8, Hospira, 2, 8, Merck Sharp & Dohme, 2, 8.

To cite this abstract in AMA style:

Tesser J, Wright G, Strand V, Kaine J, Maslova K, St John G, Ford K, Praestgaard A, Choy E. Association Between Changes in C-reactive Protein at Week 12 and Patient-Reported Outcomes at Week 24 with Sarilumab Therapy Across Three Pivotal Phase 3 Studies [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/association-between-changes-in-c-reactive-protein-at-week-12-and-patient-reported-outcomes-at-week-24-with-sarilumab-therapy-across-three-pivotal-phase-3-studies/. Accessed .

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