Latest news with #methotrexate
Medscape
3 hours ago
- Health
- Medscape
Year-Long Methotrexate Not Helpful for Inflammatory Knee OA
Compared with placebo, low-dose methotrexate administered weekly at doses up to 15 mg for 52 weeks did not relieve knee pain or reduce the size of effusion-synovitis in patients with inflammatory knee osteoarthritis (OA). METHODOLOGY: Researchers in China conducted a multicenter, clinical trial between July 2019 and January 2023 to examine whether low-dose methotrexate can reduce knee pain and effusion-synovitis in knee OA. They included 215 patients (mean age, 60.6 years; 89% women) with inflammatory knee OA and effusion-synovitis who were randomly assigned to receive either methotrexate or placebo, with weekly 5 mg folic acid supplementation given 1 day after treatment. Participants continued their regular medications (except corticosteroids and anti-synovitis drugs), did not take trimethoprim, and avoided alcohol during the trial. Primary outcomes were changes in knee pain on the visual analog scale (VAS) and inflammation measured by the effusion-synovitis maximal area on MRI over 52 weeks. Secondary outcomes were assessment of pain, stiffness, and physical function; changes in infrapatellar fat pad signal intensity; and evaluation of response to the assigned treatment. TAKEAWAY: At week 52, no significant difference was found between methotrexate and placebo groups in terms of VAS pain and effusion-synovitis maximal area (between-group difference, 0.3 mm; 95% CI, -6.7 to 7.3 mm and 0.1 cm 2 ; 95% CI, -0.8 to 1.0 cm 2 , respectively). ; 95% CI, -0.8 to 1.0 cm , respectively). No significant differences were observed between the two groups in terms of any of the prespecified secondary outcomes. The frequency of experiencing at least one adverse event was comparable between the methotrexate and placebo groups (29.6% and 24.3%, respectively); however, elevated concentrations of liver enzymes were more common in the methotrexate group. IN PRACTICE: 'Given the lack of efficacy of MTX [methotrexate] across knee OA studies and the known potential adverse events, it is not recommended for the treatment of painful, inflammatory knee OA. We now need to focus our attention on treatments that can both inhibit joint inflammation and stimulate chondrocytes within the cartilage to synthesize replacement matrix. The future of pharmaceuticals for knee OA needs to move past MTX,' Nancy E. Lane, MD, UC Davis Health, Sacramento, California, wrote in an accompanying editorial. SOURCE: This study was led by Zhaohua Zhu, PhD, Zhujiang Hospital, Southern Medical University, Guangzhou, China. It was published online on June 2, 2025, in JAMA Internal Medicine . LIMITATIONS: This study was conducted during COVID-19 shutdowns, which delayed recruitment and potentially increased loss to follow-up and nonadherence rates. The findings may not be fully generalizable because most participants were women, and racial and ethnic diversity was limited. The relatively small number of participants in each subgroup may have limited the ability to detect significant benefits in specific populations. DISCLOSURES: This study received funding from the National Key Research and Development Program of China, the National Natural Science Foundation of China, and the Clinical Research Startup Program of Southern Medical University. One author reported providing consulting advice on scientific advisory boards for various pharmaceutical companies outside the submitted work.
Medscape
3 days ago
- Business
- Medscape
Tocilizumab, Alone or With Methotrexate, Potent in Active RA
Subcutaneous tocilizumab, either as monotherapy or in combination with methotrexate, demonstrated greater efficacy than methotrexate alone and was well tolerated in patients with active rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). METHODOLOGY: Researchers conducted a phase 3 trial at 19 sites in China between July 2017 and August 2022 to evaluate the efficacy of subcutaneous tocilizumab, administered either as monotherapy or in combination with methotrexate, in 340 patients with moderate to severe active RA (mean age, 47.5 years; 86.5% women). The patients had a diagnosis of RA for ≥ 6 months, had received methotrexate for ≥ 12 weeks, experienced treatment failure with at least one csDMARD (including methotrexate), had at least six swollen joints and at least eight tender joints, and had either a high-sensitivity C-reactive protein level ≥ 4 mg/L or an erythrocyte sedimentation rate ≥ 28 mm/h. Patients were randomly assigned to receive tocilizumab-methotrexate combination therapy (n = 136), tocilizumab monotherapy with placebo (n = 136), or methotrexate monotherapy with placebo (n = 68) for 24 weeks. Tocilizumab (162 mg) was administered subcutaneously once every 2 weeks, and methotrexate (10-25 mg) was administered orally once every week. Patients achieving a Disease Activity Score in 28 joints of ≤ 3.2 after 24 weeks continued their randomly assigned treatment, whereas those with a score > 3.2 switched to unblinded tocilizumab-methotrexate treatment. The primary efficacy endpoint was the proportion of patients who achieved a ≥ 20% improvement in the American College of Rheumatology (ACR20) response criteria at 24 weeks, with long-term efficacy analyzed at 48 weeks and safety monitored for 56 weeks. TAKEAWAY: The ACR20 response rate at 24 weeks was higher in the tocilizumab-methotrexate combination therapy (52.9%) and tocilizumab monotherapy (50.0%) groups than in the methotrexate monotherapy group (25.0%), with significant differences of 27.9 and 25.0 percentage points, respectively ( P < .001 for both). < .001 for both). Long-term efficacy analysis at 48 weeks showed maintained or improved efficacy in patients continuing tocilizumab monotherapy or tocilizumab-methotrexate combination therapy, with an improved disease status in those who switched to unblinded tocilizumab-methotrexate treatment at 24 weeks. Tocilizumab was well tolerated as both monotherapy and in combination with methotrexate, with no new safety signals. IN PRACTICE: 'Subcutaneous tocilizumab, both as monotherapy and in combination with methotrexate, had clinically significant efficacy compared with methotrexate monotherapy in Chinese patients with moderate to severe active RA,' the authors wrote. SOURCE: This study was led by Tian Liu, MD, Peking University People's Hospital in Beijing, China. It was published online on May 19, 2025, in JAMA Network Open . LIMITATIONS: Only Chinese patients were included, thus limiting the generalizability of the findings. Researchers did not include imaging analysis. The recruitment was extended over a period of 4 years owing to the COVID-19 pandemic, which resulted in missing the efficacy assessments and tocilizumab administration in some patients. DISCLOSURES: This study received funding from and was conducted in collaboration with F. Hoffmann-La Roche Ltd. Three authors reported receiving grants from various pharmaceutical companies, including Roche. Two authors reported being employed by Roche (China) Holding.
