ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2011

Olokizumab Improves Patient Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate: Results from the Double-Blind, Randomized Controlled Phase III Study

Evgeny Nasonov1, Saeed Fatenejad2, Mariana Ivanova3, Diana Krechikova4, Sofia Kuzkina5, Alexey Maslyanskiy6, Tatiana Plaksina7, Mikhail Samsonov5, Marina Stanislav1, Tamara Tyabut8, Irina Vinogradova9, Sergey Yakushin10, Elena Zonova11 and Mark Genovese12, 1FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow, Russia, 2SFC Medica, LLC, Charlotte, NC, 3UMHAT St. Ivan Rilski, Clinic of Rheumatology, Sofia, Bulgaria, 4Non-governmental Healthcare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"”, Smolensk, Russia, 5JSC “R-Pharm”, Moscow, Russia, 6SBHI "North-West Federal Medical Research Center n.a. V.A.Almazov", Saint Petersburg, Russia, 7SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. P.A.Semashko", Nizhny Novgorod, Russia, 8Belarusian Medical Academy of Postgraduate Education, Minsk, Russia, 9Ulyanovsk Regional Clinical Hospital, Ulyanovsk, Russia, 10Ryazan State Medical University, Ryazan, Russia, 11Novosibirsk State Medical University, State Clinical Polyclinic, Novosibirsk, Russia, 12Stanford University Medical Center, Palo Alto, CA

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Monday, November 9, 2020

Session Title: RA – Treatments IV: New Therapies & Strategies (2008–2012)

Session Type: Abstract Session

Session Time: 5:00PM-5:50PM

Background/Purpose: We previously reported positive efficacy and safety results of olokizumab (OKZ), an interleukin-6-inhibitor, in patients with RA inadequately controlled by MTX (NCT02760368; CREDO-1) [Nasonov E.et al. Arthritis Rheumatol. 2019; 71 (suppl 10); E. Nasonov,et al. 2020; EULAR Abstracts THU0176]. Here we present the patient reported outcomes (PRO) of CREDO-1 study and assess the effect of OKZ treatment comparing to placebo (PBO) on quality of life, work productivity and fatigue in patients with moderate to severe RA who have previously failed MTX therapy.

Methods: We compared PRO between three groups 1) subcutaneous injections of OKZ 64 mg every 2 weeks (q2w), 2) OKZ 64 mg every 4 weeks (q4w) and 3) PBO every q2w.

PRO included change from baseline in: Health Assessment Questionnaire-Disability Index (HAQ-DI); Patient’s Global Assessment of Disease Activity (PtGA), Patient’s Assessment of Arthritis Pain (Pain), Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) components; European Quality of Life- Five-Dimension Questionnaire (EQ-5D), Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) and Work Productivity Survey-Rheumatoid Arthritis (WPS-RA).

Results: 428 patients were enrolled and 396 completed the study. All PRO baseline characteristics were comparable across treatment arms: mean (SD) PtGA was 69.5 (15.5); Pain was 68.6 (17.5); HAQ-DI was 1.7 (0.5); SF-36 PCS was 32.1 (6.5); SF-36 MCS was 42.3 (10.0); EQ-5D was 40.3 (20.0) and FACIT-F was 26.8 (8.7).

Treatment with OKZ 64 mg q2w and 64 mg q4w resulted in significant improvement in PRO measures (Table 1). Improvements in all PRO measures observed at week 12 were sustained over week 24.

Mean improvements in both OKZ groups for PtGA, Pain, HAQ-DI, SF-36 PCS and MCS, and FACIT-F surpassed defined MCIDs for these measures. There were clear differences between both OKZ treatment groups and placebo in all PRO measures, with the exception of some WPS measures where differences between groups were variable. There were statistically significant changes between OKZ treatment groups and placebo for change from baseline in HAQ; however, no formal statistical testing was done for other PRO measures. No notable differences in PRO measures were observed between the two dose regimens of OKZ.

Conclusion:

  1. Treatment with OKZ over a 24-week period was associated with significant improvements in PRO in patients with moderate to severe RA.
  2. There were no discernible differences between the two regimens of OKZ from patient’s perspective.

PtGA, Patient’s Global Assessment of Disease Activity; Pain, Patient’s Assessment of Arthritis Pain; PCS, HAQ-DI, Health Assessment Questionnaire-Disability Index; SF-36, Short Form-36; PSC, Physical Component Score; MCS, Mental Component Score; EQ-5, European Quality of Life-5 Dimensions; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue Scale; WPS-RA, Work Productivity Survey-Rheumatoid Arthritis.

Disclosure: E. Nasonov, Eli Lilly, 5, 8, AbbVie, 8, Pfizer, 8, BIOCAD, 8, R-Pharm, 8; S. Fatenejad, JSC “R-Pharm”, 5; M. Ivanova, JSC “R-Pharm”, 2; D. Krechikova, Janssen, 8, Eli Lilly, 8, Celtrion, 8, R-Pharm, 8; S. Kuzkina, JSC “R-Pharm”, 3; A. Maslyanskiy, R-Pharm, 5; T. Plaksina, R-Pharm, 2; M. Samsonov, JSC “R-Pharm”, 3; M. Stanislav, R-Pharm, 5, Janssen, 2, Celtrion, 2, Sanofi Aventis, 2; T. Tyabut, KRKA, 8, Gedeon Richter, 8, R-Pharm, 2, MEDPACE, 2, ABBVE, 2; I. Vinogradova, R-Pharm, 2, Eli Lilly, 2, GSK, 2, MSD, 2, Yanssen, 2, Bayer, 2; S. Yakushin, R-Pharm, 2; E. Zonova, R-Pharm, 2, Pfizer, 8, Novartis, 8, AbbVie, 8, Bayer, 8; M. Genovese, Abbvie, 2, 5, Eli Lilly and Company, 2, 5, Galapagos, 2, 5, Gilead Sciences Inc., 2, 5, Pfizer, 2, 5, EMD Merck Serono, 2, 5, Genentech/Roche, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, RPharm, 2, 5, Sanofi-Genzyme, 2, UCB, 5, Amgen, 5.

To cite this abstract in AMA style:

Nasonov E, Fatenejad S, Ivanova M, Krechikova D, Kuzkina S, Maslyanskiy A, Plaksina T, Samsonov M, Stanislav M, Tyabut T, Vinogradova I, Yakushin S, Zonova E, Genovese M. Olokizumab Improves Patient Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate: Results from the Double-Blind, Randomized Controlled Phase III Study [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/olokizumab-improves-patient-reported-outcomes-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis-inadequately-controlled-by-methotrexate-results-from-the-double-blind-randomized-con/. Accessed January 15, 2021.

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