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Effect of Ozoralizumab Administration with or without Methotrexate in Patients with Rheumatoid Arthritis: A Post-Hoc
Yoshiya Tanaka1, Nobuko Horiuchi2, Cosmo Sasajima2
1The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Kitakyushu, Fukuoka, 807-8555, Japan. tanaka@med.uoeh-u.ac.jp.
Introduction:
Ozoralizumab (OZR) is a novel tumor necrosis factor (TNF) inhibitor that was launched in Japan for treating patients with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. This post-hoc analysis aimed to compare the efficacy of OZR administered without methotrexate (MTX) with placebo or OZR administration in combination with MTX.
Methods:
We analyzed the OZR group (30 mg) in the NATSUZORA trial (non-MTX, open trial) (OZR group; n = 94) and the placebo group (MTX group; n = 75) and the 30-mg OZR group (OZR + MTX group; n = 152) in the OHZORA trial (combined MTX, double-blind trial), and the covariates were adjusted by propensity score matching. Subsequently, the American College of Rheumatology (ACR) 20/50/70 response rates from baseline to 24 or 52 weeks were compared. Furthermore, to compare longitudinal data on disease activity indicators, a mixed-effects model for repeated-measures analyses was used.
Results:
Comparing the OZR and MTX groups, 52 patients were matched in each group. The OZR group showed improvements in the ACR20 (OZR group, 67.3% vs. MTX group, 34.6%, p = 0.001), ACR50 (51.9% vs. 17.3%, p < 0.001), and ACR70 (26.9% vs. 11.5%, p = 0.047) response rates compared to those in the MTX group. Comparing the OZR and OZR + MTX groups, 77 patients were matched in each group. No significant difference was observed in the ACR20 response rate (OZR group, 58.4% vs. OZR + MTX group, 70.1%, p = 0.130). However, the OZR + MTX group showed higher ACR50 (44.2% vs. 62.3%, p = 0.024) and ACR70 (29.9% vs. 45.5%, p = 0.046) response rates.
Conclusion:
OZR administration without MTX was associated with an improvement in the signs and symptoms of RA compared to placebo administration (continuation of MTX monotherapy). OZR and MTX administration showed better efficacy than OZR administration alone.
Insights
Ozoralizumab (OZR) monotherapy improved rheumatoid arthritis (RA) symptoms compared to placebo. Combining OZR with methotrexate (MTX) demonstrated superior efficacy over OZR alone for moderate to severe RA.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Ozoralizumab (OZR) is a novel biologic therapy targeting tumor necrosis factor (TNF).
- OZR is approved in Japan for rheumatoid arthritis (RA) patients with inadequate response to existing treatments.
- This study evaluates OZR efficacy with and without methotrexate (MTX).
Purpose of the Study:
- To compare the efficacy of Ozoralizumab (OZR) monotherapy versus placebo (MTX continuation).
- To compare the efficacy of OZR in combination with methotrexate (MTX) versus OZR monotherapy.
- To assess treatment outcomes in rheumatoid arthritis patients.
Main Methods:
- Post-hoc analysis of NATSUZORA (OZR monotherapy) and OHZORA (OZR + MTX) trial data.
- Propensity score matching used to adjust for covariates between treatment groups.
- American College of Rheumatology (ACR) 20/50/70 response rates and mixed-effects models for repeated measures analyzed.
Main Results:
- OZR monotherapy showed significantly higher ACR20, ACR50, and ACR70 response rates compared to placebo (MTX continuation).
- No significant difference in ACR20 response between OZR and OZR + MTX groups.
- The OZR + MTX combination therapy demonstrated significantly higher ACR50 and ACR70 response rates compared to OZR monotherapy.
Conclusions:
- Ozoralizumab monotherapy provides significant clinical improvement in RA symptoms compared to placebo.
- Combination therapy with Ozoralizumab and methotrexate is more effective than Ozoralizumab alone for rheumatoid arthritis.
- These findings support OZR as a valuable therapeutic option for RA, with enhanced benefits when combined with MTX.
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