Efficacy and safety of olokizumab drug are studied:
In non-clinical studies
As part of Phase I and II clinical trials (CTs)
In three international Phase III clinical trials with 2,444 adult patients diagnosed with rheumatoid arthritis of moderate to severe activity (CREDO 1, 2, 3)
Clinical efficacy
In the general, open-label, long-term study in patients who completed one of Phase III clinical trials.
96% of patients decided to continue treatment with olokizumab in the general, open-label, long-term trial
CREDO 2
CREDO 3
CREDO 1
CREDO 4
Phase III, randomized, double-blind, placebo-controlled, multi-center study in parallel groups to assess efficacy and safety of olokizumab safety in patients with moderate to severe rheumatoid arthritis that is not sufficiently controlled with Methotrexate (CREDO 1), protocol No. CL04041022; permission of the Russian Health Ministry No. 324 dd 13/05/2016.

Reference to: National Register of Clinical Studies
Reference to: U.S. National Library of Medicine
Phase III, randomized, double-blind, multi-center study in parallel groups with placebo and active control for assessment of efficacy and safety of olokizumab in patients with moderate to severe rheumatoid arthritis, which is insufficiently controlled with Methotrexate (CREDO 2), protocol No. CL04041023; permission of the Russian Ministry of Health No. 356 dd 24/05/2016.

Reference to: National Register of Clinical Studies
Reference to: U.S. National Library of Medicine
Phase III, randomized, double-blind, placebo-controlled, multi-center study in parallel groups to assess efficacy and safety of olokizumab in patients with moderate to severe rheumatoid arthritis that is not sufficiently controlled with alpha tumor necrosis factor inhibitors (CREDO 3), protocol No. CL04041025; permission of the Russian Ministry of Health No. 389 dd 07/06/2016.

Reference to: National Register of Clinical Studies
Reference to: U.S. National Library of Medicine
Multi-center, open-label, Phase III study to assess olokizumab efficacy and safety in patients with moderate to severely active rheumatoid arthritis (CREDO 4), protocol CL04041024; permission of the Russian Ministry of Health No. 670 dd 20/09/2016.

Reference to: National Register of Clinical Studies
Reference to: U.S. National Library of Medicine
2444 patients from 19 countries with majority from the Russia, US, EU and South American countries
Source
Clinincal
program CREDO
Source
Olokizumab proved its effectiveness and safety in the CREDO clinical program
Patients with a follow-up period of up to 2,5 years
CREDO 1
CREDO 2
CREDO 3
Results for all endpoints were achieved and were statistically significantly superior to placebo, and in CREDO2 were comparable to active control
CREDO 4
continued therapy
No new safety signals compared to other IL-6 drugs.
Low immunogenicity of olokizumab throughout the observation period.
Long-term (up to 106 weeks of observation) retention of patients on therapy and maintenance of the achieved response according to the main effectiveness indicators.
Source
CREDO 1
3 countries:
patients with
insufficient MT efficacy
Phase III, randomized, double-blind, placebo-controlled, multi-center study in parallel groups to assess efficacy and safety of olokizumab safety in patients with moderate to severe rheumatoid arthritis that is not sufficiently controlled with Methotrexate (CREDO 1), protocol No. CL04041022; permission of the Russian Health Ministry No. 324 dd 13/05/2016.
428
Source
Efficacy assesment response dynamics CREDO 1
ACR20
Primary endpoint
ACR50
Secondary endpoint
DAS28 < 3.2
Secondary endpoint
CDAI ≤ 2.8
Secondary endpoint
HAQ-DI
Secondary endpoint
CREDO 1
Olokizumab every 4 week in patients with insufficient response to methotrexate was statistically significantly superior to placebo in all endpoints.
Source
CREDO 2
18 countries, including:
Phase III, randomized, double-blind, multi-center study in parallel groups with placebo and active control for assessment of efficacy and safety of olokizumab in patients with moderate to severe rheumatoid arthritis, which is insufficiently controlled with Methotrexate (CREDO 2), protocol No. CL04041023; permission of the Russian Ministry of Health No. 356 dd 24/05/2016.
patients with insufficient
efficiency of MTX and active (adalimumab) control
1648
Efficacy assesment response dynamics CREDO 2
ACR20
Primary endpoint
ACR50
Secondary endpoint
DAS28 < 3.2
Secondary endpoint
CDAI ≤ 2.8
Secondary endpoint
HAQ-DI
Secondary endpoint
CREDO 2
Olokizumab every 4 week was statistically significantly more effective than placebo and was not inferior to the comparator product (adalimumab) for all endpoints in patients with inadequate response to methotrexate.
Source
CREDO 3
11 countries, including:
Phase III, randomized, double-blind, placebo-controlled, multi-center study in parallel groups to assess efficacy and safety of olokizumab in patients with moderate to severe rheumatoid arthritis that is not sufficiently controlled with alpha tumor necrosis factor inhibitors (CREDO 3), protocol No. CL04041025; permission of the Russian Ministry of Health No. 389 dd 07/06/2016.
patients with insufficient
effectiveness of TNFα
368
Source
Efficacy assesment response dynamics CREDO 3
ACR20
Primary endpoint
DAS28 < 3.2
Secondary endpoint
CDAI ≤ 2.8
Secondary endpoint
HAQ-DI
Secondary endpoint
CREDO 3
Olokizumab 64 mg once every 4 week was statistically significantly superior to placebo in primary endpoint in patients with insufficient response to iTNFα

After switch to OKZ at week 16, patients from the placebo group within 8 weeks achieved the same response as those patients who initially used OKZ.
Source
Dynamics
of C-reactive protein levels at week 12*
Source
CREDO 4
18 countries, including:
Multi-center, open-label, Phase III study to assess olokizumab efficacy and safety in patients with moderate to severely active rheumatoid arthritis (CREDO 4), protocol CL04041024; permission of the Russian Ministry of Health No. 670 dd 20/09/2016.
pacients
2105
Source
Patients with RA who completed a 24-week double-blind treatment period in one of the 3 main studies (CREDO 1, CREDO 2, CREDO 3)
Source
Efficacy assesment response dynamics CREDO 4
ACR20
Primary endpoint
ACR50
Secondary endpoint
DAS28 < 3.2
Secondary endpoint
CREDO 4
Olokizumab 64 mg once every 4 weeks shows long-term up to 106 weeks of follow-up retention of patients on therapy and preservation of the achieved response according to the main performance indicators.
Source
Long-term therapy on olokizumab
provides control
of rheumatoid arthritis according to CREDO 4
Source
Patients maintained low RA activity
for more than
1,5 years