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THU0176 (2020)
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 (CREDO-1)
E. Nasonov1, M. Ivanova2, M. Samsonov3, T. Tyabut4, M. C. Genovese5, on behalf of Saeed Fatenejad (United States of America), Diana Krechikova, Sofia Kuzkina, Alexey Maslyansky, Tatiana Plaksina, Marina Stanislav, Sergey Yakushin, Elena Zonova (Russian Federation).
1SRI of Rheumatology n.a. V.A. Nasonova”, Moscow, Russian Federation
2University Hospital “St. Ivan Rilski”, Sofia, Bulgaria
3JSC “R-Pharm”, Moscow, Russian Federation
4Belarusian Medical Academy of Postgraduate Education, Minsk, Belarus
5Stanford University, Stanford, United States of America

Background: We previously reported positive efficacy and safety results of olokizumab (OKZ), an interleukin-6-inhibitor, in patients with Rheumatoid Arthritis (RA) inadequately controlled by methotrexate (MTX) (NCT02760368; CREDO-1) 1 . Here we present the patient reported outcomes (PRO) of CREDO-1 study.


Objectives: To 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 persistent up to week 24.

Changes from baseline at 12 week and 24 week for PRO measures

Score , LSM change from baseline (SE) LSM difference vs PBO 97.5% CI for LSM difference Week 12 Week 24
OKZ q2w (n=143) OKZ q4w (n=142) OKZ q2w (n=143) OKZ q4w (n=142)
PtGA -30.6 (1.72) -17.5 -23.0, -12.0 -31.0 (1.73) -17.9 -23.4, -12.4 -32.1 (1.92) -12.7 -18.8, -6.6 -36.3 (1.96) -16.8 -23.0, -10.6
Pain -31.6 (1.82) -18.7 -24.6, -12.9 -31.8 (1.83) -19.0 -24.8, -13.1 -34.5 (2.05) -13.0 -19.5, -6.5 -37.1 (2.08) -15.7 -22.3, -9.1
HAQ-DI† -0.54 (0.04) -0.34*** -0.47, -0.21 -0.56 (0.04) -0.36*** -0.49, -0.23 -0.55 (0.05) -0.27 -0.43, -0.12 -0.65 (0.05) -0.37 -0.53, -0.22
SF-36 PCS 6.72 (0.57) 4.53 2.72, 6.33 6.03 (0.57) 3.84 2.01, 5.67 7.84 (0.67) 4.30 2.19, 6.41 8.73 (0.68) 5.20 3.04, 7.35
SF-36 MCS 6.48 (0.73) 3.01 0.69, 5.33 7.04 (0.73) 3.57 1.23, 5.92 6.21 (0.79) 3.72 1.23, 6.22 8.86 (0.80) 6.37 3.82, 8.92
EQ-5D Health Today Score 19.7 (1.69) 12.2 6.8, 17.6 18.7 (1.72) 11.2 5.8, 16.7 20.9 (1.95) 12.6 6.5, 18.7 23.6 (2.01) 15.3 8.9, 21.7
FACIT-F 8.2 (0.67) 4.6 2.4, 6.8 8.7 (0.68) 5.1 2.9, 7.3 8.5 (0.80) 4.8 2.3, 7.3 10.6 (0.81) 6.9 4.3, 9.5

†, secondary endpoint; *** P‹0.0001.

PRO changes were analyzed using ANCOVA model adjusted for the baseline value of the corresponding parameter. Missing data resulted from study withdrawal imputed based on the return to baseline assumption.

Mean improvements in both OKZ groups over PBO for PtGA, Pain, HAQ-DI, SF-36 PCS and MCS, and FACIT-F surpassed defined MCIDs for these measures. No notable differences in PRO measures were observed between the two dose regimens of OKZ.


Conclusion:

  1. 1. Treatment with OKZ over a 24-week period was associated with significant improvements in PRO in patients with moderate to severe RA.

  2. 2. There were no discernible differences between the two regimens of OKZ from patient’s perspective.


REFERENCES:

[1]Nasonov E.et al. Arthritis Rheumatol. 2019; 71 (suppl 10).


Acknowledgments: All patients and investigators of CREDO-1 study.


Disclosure of Interests: Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm, Mariana Ivanova Grant/research support from: R-Pharm, Mikhail Samsonov Employee of: R-Pharm, Tamara Tyabut: None declared, Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme

Citation: Ann Rheum Dis, volume 79, supplement 1, year 2020, page 300
Session: Rheumatoid arthritis - biological DMARDs (Poster Presentations)