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Trivalent chromium versus baricitinib for rheumatoid arthritis treatment: first phase 2/3 randomized controlled
Sally S Hassouna1, Omneya Mohamed-Ayman Abdel-Moniem2
1Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Alexandria University, Alexandria, Egypt. s_hassouna151@alexmed.edu.eg.
Insights
Trivalent chromium (Cr III) shows superior efficacy and safety compared to baricitinib in treating rheumatoid arthritis (RA), demonstrating faster clinical and sonographic improvements with fewer side effects.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Rheumatoid arthritis (RA) is a chronic inflammatory disease managed with disease-modifying antirheumatic drugs (DMARDs).
- Baricitinib, an emerging DMARD, offers anti-rheumatic effects but carries significant side effects.
- Trivalent chromium (Cr III), a natural anti-inflammatory agent, is investigated for RA treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of trivalent chromium (Cr III) in treating RA patients.
- To compare the therapeutic effects of Cr (III) with baricitinib in RA management.
- To assess clinical and sonographic outcomes and side effect profiles of Cr (III) versus baricitinib.
Main Methods:
- A phase 2/3 randomized controlled trial involving RA patients.
- Patients were randomized 2:1 to receive either Cr (III) or baricitinib.
- Disease activity was assessed using DAS28-CRP and DAS28-ESR, ACR scores, and hand ultrasound at baseline, 3 weeks, and 12 weeks.
Main Results:
- Cr (III) demonstrated statistically significant improvements in DAS28-CRP and DAS28-ESR compared to baricitinib (p < 0.001).
- Higher ACR 50 and ACR 70 response rates were observed with Cr (III) versus baricitinib.
- Significant improvements in ultrasound parameters (GLOESS, SH, PDUS, joint effusions) were noted with Cr (III), while baricitinib showed worsening in joint effusions.
Conclusions:
- Trivalent chromium (Cr III) exhibits promising and rapid clinical and sonographic efficacy in RA patients, outperforming baricitinib in several aspects.
- Cr (III) appears to be a potentially safer alternative with fewer side effects compared to baricitinib and other DMARDs.
- Long-term safety data for Cr (III) in RA treatment require further investigation.
Background:
Rheumatoid arthritis (RA) is a debilitating disease mainly treated by DMARDs. Baricitinib is one of the emerging DMARDs with strong anti-rheumatic effects but has serious side effects. Trivalent chromium (Cr III) is a natural element with anti-inflammatory properties. Trivalent chromium (Cr III) is introduced for the first time to study its effect and safety in treatment of RA patients and compared to those of baricitinib.
Methods:
This is a phase 2/3 randomized controlled trial where RA patients were divided in a ratio of 2:1 according to the newly introduced medication either Cr (III) (group A) or baricitinib (group B). Patients attended three visits on day 0, after 3 weeks and 12 weeks, disease activity was scored. Hands ultrasound was done and reassessed. Side effects were monitored throughout the study.
Results:
DAS28-CRP improved by 26.9% and 11.8% on third visit for Cr III and baricitinib, respectively (p = 0.001). DAS28-ESR improved by 25.6% and 7.74% on third visit for Cr III and baricitinib, respectively (p = < 0.001). ACR 50 was 18.8% for Cr III and 5.7% for baricitinib on second visit. ACR 70 was 25% for Cr III and 0% for baricitinib on third visit (P = < 0.001). Ultrasound GLOESS, SH, PDUS, joints effusions improved by 38.9%, 38.4%, 56.7% and 74.8% for Cr III, while by 10.5%, 3.75%, 59.6% and worsening of joints effusions happened with baricitinib on third visit. p = 0.022 and 0.002 between groups for GLOESS and SH improvement, respectively.
Conclusions:
Cr III has shown very promising fast clinical and sonographic results in treating RA patients which were surprisingly superior to baricitinib in most aspects. Furthermore, Cr III is potentially safe with evidently fewer side effects than baricitinib and other DMARDs, however, long-term safety is still not established. (IRB No.: 00012098- FWA No.: 00018699, Serial number: 040457) ClinicalTrials.gov ID: NCT05545020.
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