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Rheumatoid arthritis is a chronic inflammatory joint disease that manifests it as joint damage, pain, and dysfunction, and can lead to associated complications and increased mortality, while early active treatment can significantly improve outcomes.
has been controversial about the best first-line treatments for early-stage rheumatoid arthritis patients, particularly whether bio-disease improvement drugs should be included in treatment options.
currently, treatment recommendations in Europe and the United States promote the early treatment of conventional slow-synthetic disease improvement drugs with methotrexate as an anchoring drug.
addition of low to medium doses of corticosteroids (called active routine therapy) to methotrexate in the short term may optimize treatment effectiveness.
bio-disease-improved rheumatoids with different forms of action have been introduced, and the most commonly used drugs used in the early stages of the disease are TNF-α, T-cell costulant inhibitors and IL-6 inhibitors.
previous studies have shown that first-time patients treated with the biopharmaceline combination methotrexate were more effective than those treated with methotrexate and placebo alone.
There are several biological drugs that can be used for the disease, and their efficacy needs to be compared with each other in untreated patients, and more research is needed to determine whether one or more biological agents are more beneficial or safer, or more suitable for different subgroups of rheumatoid arthritis patients.
As a result, researchers from Scandinavia and the Netherlands conducted a randomized trial that looked at the relative benefits and safety of biologic and conventional drugs in untreated rheumatoid arthritis patients.
the first part of this trial, their goal was to evaluate and compare the efficacy and safety of different therapies after 24 weeks.
Where conventional treatments are methotrexate combined oral corticosteroids or methotrexate combined liver injection therapy, as well as corticosteroids and other conventional synthetic anti-rheumatoid drugs, three biological therapies are methotrexate combined with TNF inhibitors (Setobede monoantigen), T-cell co-stimulation blockers (Abahip) and IL-6 inhibitors (toad monoantigen).
They randomly divided 812 eligible patients into four groups in a 1:1:1:1 ratio, with all participants initially receiving (a) methotrexate combined routine treatment (pyrithione gradually reduced to 5 mg/day, or lysovine sulfonamide in combination with hydroxychloroquine and intra-joint injection corticosteroids), (b) methotrexate monoantitor, (c) abahip, or (d) tobasin.
outcome was that the groups adjusted for the remission of clinical disease activity indicators at 24 weeks compared to conventional treatment (CDAI≤2.8).
key secondary outcomes and analyses include CDAI mitigation at 12 weeks and beyond, other mitigation criteria, non-poor performance analysis, and hazards.
age of 812 patients was 54.3 years (standard deviation 14.7) and 68.8 per cent for women.
28 joints had a baseline disease activity score of 5.0 (standard deviation 1.1).
the CDAI remission rate after 24 weeks was 42.7% (95% confidence interval 36.1% to 49.3%), the Setoju monoantigroup was 46.5% (39.9% to 53.1%), and the Abaaz group was 52.0% (45.5% to 58.6%), The toad was 42.1% (35.3% to 48.8%).
absolute difference was 3.9 per cent (95 per cent confidence interval to 13.2 per cent), 9.4 per cent (0.1 to 18.7 per cent) in the Abassip group and -0.6 per cent (-10.1% to 8.9%) in the to-bead single resistance group.
key secondary outcomes show no significant differences between the four therapies.
differences in CDAI mitigation rates (excluding Abasip) between active conventional treatment and Cyto-bead monoantigen (excluding Abasip) are still within the predetermined 15% non-inferior range (by programme population).
total number of serious adverse events in routine treatment was 13 (5.6 percent of patients who experienced at least one event), 20 (8.4 percent) for cytojub, 10 (4.9 percent) for Abahip, and 10 (4.9 percent) for toads.
11 patients treated with abahip stopped treatment earlier than 20-23 patients in other groups.
four treatments achieved high remission rates.
compared with active conventional treatment, the Abahip group observed a higher CDAI remission rate, while the cyto-pearl mono-anti-group and the to-bead mono-resistance group did not see a higher CDAI remission rate.
non-poor performance analysis shows that the active conventional treatment is no less than the cyto-pearl mono-resistance and the to-bead mono-resistance, but can not be compared with Abahip.
the results highlighted the effectiveness and safety of active conventional therapy based on a combination of methotrexate and corticosteroids, but Abrasip's treatment was significantly better in early treatment of rheumatoid arthritis.
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