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Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid
Background:
Many patients with rheumatoid arthritis (RA) do not achieve adequate and safe responses with disease-modifying antirheumatic drugs (DMARDs). Tofacitinib is a novel, oral, Janus kinase inhibitor that treats RA.
Objective:
To evaluate the efficacy and safety of tofacitinib in combination with nonbiologic DMARDs.
Design:
1-year, double-blind, randomized trial (ClinicalTrials.gov: NCT00856544).
Setting:
114 centers in 19 countries.
Patients:
792 patients with active RA despite nonbiologic DMARD therapy.
Intervention:
Patients were randomly assigned 4:4:1:1 to oral tofacitinib, 5 mg or 10 mg twice daily, or placebo advanced to tofacitinib, 5 mg or 10 mg twice daily.
Measurements:
Primary end points were 20% improvement in American College of Rheumatology (ACR20) criteria; Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6; DAS28-4(ESR)-defined remission, change in Health Assessment Questionnaire Disability Index (HAQ-DI) score, and safety assessments.
Results:
Mean treatment differences for ACR20 response rates (month 6) for the 5-mg and 10-mg tofacitinib groups compared with the combined placebo groups were 21.2% (95% CI, 12.2% to 30.3%; P < 0.001) and 25.8% (CI, 16.8% to 34.8%; P < 0.001), respectively. The HAQ-DI scores (month 3) and DAS28-4(ESR) less than 2.6 response rates (month 6) were also superior in the tofacitinib groups versus placebo. The incidence rates of serious adverse events for patients receiving 5-mg tofacitinib, 10-mg tofacitinib, or placebo were 6.9, 7.3, or 10.9 events per 100 patient-years of exposure, respectively. In the tofacitinib groups, 2 cases of tuberculosis, 2 cases of other opportunistic infections, 3 cardiovascular events, and 4 deaths occurred. Neutrophil counts decreased, hemoglobin and low- and high-density lipoprotein cholesterol levels increased, and serum creatinine levels had small increases in the tofacitinib groups.
Limitations:
Placebo groups were smaller and of shorter duration. Patients received primarily methotrexate. The ability to assess drug combinations other than tofacitinib plus methotrexate was limited.
Conclusion:
Tofacitinib improved disease control in patients with active RA despite treatment with nonbiologic DMARDs, primarily methotrexate.
Primary Funding Source:
Pfizer.
Insights
Tofacitinib effectively improved disease control in patients with active rheumatoid arthritis (RA) when added to nonbiologic disease-modifying antirheumatic drugs (DMARDs). This oral Janus kinase inhibitor demonstrated significant efficacy in ACR20 response rates and disease activity scores.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Many rheumatoid arthritis (RA) patients show inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs).
- Tofacitinib, an oral Janus kinase (JAK) inhibitor, offers a novel therapeutic option for RA management.
Purpose of the Study:
- To assess the efficacy and safety of tofacitinib when used in conjunction with nonbiologic DMARDs for RA treatment.
- Evaluate tofacitinib's impact on disease activity and patient-reported outcomes.
Main Methods:
- A 1-year, double-blind, randomized controlled trial involving 792 patients with active RA despite nonbiologic DMARD therapy.
- Patients received oral tofacitinib (5 mg or 10 mg twice daily) or placebo, with subsequent advancement to tofacitinib for placebo groups.
- Primary endpoints included ACR20 response, Disease Activity Score (DAS28-4[ESR]) < 2.6, DAS28-4(ESR)-defined remission, and Health Assessment Questionnaire Disability Index (HAQ-DI) changes.
Main Results:
- Tofacitinib groups showed significantly higher ACR20 response rates at 6 months compared to placebo (21.2% for 5 mg, 25.8% for 10 mg; P < 0.001).
- Superior improvements in HAQ-DI scores and DAS28-4(ESR) remission were observed in tofacitinib groups.
- Serious adverse event rates were 6.9 and 7.3 per 100 patient-years for 5 mg and 10 mg tofacitinib, respectively, versus 10.9 for placebo. Notable events included infections, cardiovascular events, and deaths in tofacitinib groups. Laboratory changes included decreased neutrophils and increased lipids.
Conclusions:
- Tofacitinib significantly enhanced disease control in patients with active RA inadequately managed by nonbiologic DMARDs, primarily methotrexate.
- Limitations included smaller, shorter placebo groups and restricted assessment of drug combinations beyond tofacitinib plus methotrexate.
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