Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .
Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses ≥15 mg may be overcome with subcutaneous administration
Objective To compare the relative bioavailability , safety and tolerability of oral methotrexate ( MTX ) and subcutaneous ( SC ) MTX administered via an auto-injector ( MTXAI ) in patients with rheumatoid arthritis ( RA ) . Methods In this r and omised , multicenter , open-label , three-way crossover study , patients ≥18 years with adult RA undergoing treatment with MTX for ≥3 months were assigned to receive MTX 10 , 15 , 20 and 25 mg weekly in a r and om sequence of three treatments : oral , SC into the abdomen and SC into the thigh . For 24 h after administration of each treatment , blood sample s were collected for pharmacokinetic analysis and injection sites were assessed . Results Forty-seven patients completed the study . Systemic exposure of oral MTX plateaued at doses ≥15 mg/week . In contrast , SC MTX demonstrated a linear increase in systemic exposure that was greater than oral MTX at each dose . No unexpected AEs were noted for either formulation . Conclusions Unlike oral MTX , the systemic exposure of SC MTX did not plateau over the doses studied , particularly at doses ≥15 mg/week . In this study , higher systemic MTX exposure was not associated with increases in AEs . Patients with an inadequate clinical response to oral MTX may benefit from higher drug exposure by switching to SC MTX . Trial registration number NCT01618968
Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .