To evaluate the clinical efficacy and safety of methotrexate (MTX) plus low dose glucocorticoid in the treatment of rheumatoid arthritis (RA) from the "target control" point of view.
Patients diagnosed as RA according to American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 classification criteria were enrolled. All of the patients were prescribed with 15 mg/week MTX, 5 mg/week folic acid and prednisone (not exceeding 10 mg/day) orally. At week 0, 4, 12, disease activity and clinical efficacy were recorded. Co-primary assessment criterion was disease activity score (DAS28)-based on C-reactive protein (CRP). Secondary assessment criteria included EULAR response criteria, ACR response criteria, simplified disease activity index (SDAI) , clinical disease activity index (CDAI) . The tolerability and toxicity of MTX was recorded at week 4, 12. All patients were evaluated for the occurrence of adverse drug reactions associated with prednisone at week 12.
A total of 76 patients were enrolled in the study. At week 4 and 12, 68 and 65 patients completed regular follow-up respectively. At week 12, there were 30 (46.2%), 9 (13.8%), 26 (40.0%) patients who met DAS28-CRP remission, low disease activity, middle and high disease activity criterion respectively. Three of nine patients who grouped in low disease activity after therapy were early or intermediate patients and didn't reach the target. Thus 36(55.4%) patients met the standard of target control. The percentage of patients who met the criteria of EULAR good response, the ACR criteria for 20% improvement (ACR20) , the ACR criteria for 50% improvement (ACR50), the ACR criteria for 70% improvement (ACR70) were 29.2%, 75.4%, 69.2%, 64.6%, respectively. The proportion of patients meeting the standard of treat to target using SDAI and CDAI were 76.9%, 58.5% respectively. The rate of liver injury, abdominal pain, abdominal distention and acid reflux, nausea were 11.8%, 4.4%, 4.4%, 2.9% respectively at week 4. At week 12, 4.6% of patients reported abdominal distention. There was only one patient (1.5%) each who complained of abdominal pain, nausea, loss of hair, varicella zoster virus infection and pulmonary infection at week 12. No serious adverse event was observed during the study.
Based on the view of "target control", drug efficacy and safety, MTX plus low dose prednisone is still a useful therapeutic regimen for RA at present.