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 .
Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial.
Importance One-third of patients with rheumatoid arthritis show inadequate response to tumor necrosis factor α ( TNF-α ) inhibitors ; little guidance on choosing the next treatment exists . Objective To compare the efficacy of a non-TNF-targeted biologic ( non-TNF ) vs a second anti-TNF drug for patients with insufficient response to a TNF inhibitor . Design , Setting , and Participants A total of 300 patients ( conducted between 2009 - 2012 ) with rheumatoid arthritis , with persistent disease activity ( disease activity score in 28 joints-erythrocyte sedimentation rate [ DAS28-ESR ] ≥ 3.2 [ range , 0 - 9.3 ] ) and an insufficient response to anti-TNF therapy were included in a 52-week multicenter , pragmatic , open-label r and omized clinical trial . The final follow-up date was in August 2013 . Interventions Patients were r and omly assigned ( 1:1 ) to receive a non-TNF-targeted biologic agent or an anti-TNF that differed from their previous treatment . The choice of the biologic prescribed within each r and omized group was left to the treating clinician . Main Outcomes and Measures The primary outcome was the proportion of patients with good or moderate response according to the European League Against Rheumatism ( EULAR ) scale at week 24 . Secondary outcomes included the EULAR response at weeks 12 and 52 ; at weeks 12 , 24 , and 52 ; DAS28ESR , low disease activity ( DAS28 ≤3.2 ) , remission ( DAS28 ≤2.6 ) ; serious adverse events ; and serious infections . Results Of the 300 r and omized patients ( 243 [ 83.2 % ] women ; mean [ SD ] age , 57.1 [ 12.2 ] years ;  baseline DAS28-ESR , 5.1 [ 1.1 ] ) , 269 ( 89.7 % ) completed the study . At week 24 , 101 of 146 patients ( 69 % ) in the non-TNF group and 76 ( 52 % ) in the second anti-TNF group achieved a good or moderate EULAR response ( OR , 2.06 ; 95 % CI , 1.27 - 3.37 ; P = .004 , with imputation of missing data ; absolute difference , 17.2 % ; 95 % CI , 6.2 % to 28.2 % ) . The DAS28-ESR was lower in the non-TNF group than in the second anti-TNF group ( mean difference adjusted for baseline differences , -0.43 ; 95 % CI , -0.72 to -0.14 ; P = .004 ) . At weeks 24 and 52 , more patients in the non-TNF group vs the second anti-TNF group showed low disease activity ( 45 % vs 28 % at week 24 ; OR , 2.09 ; 95 % CI , 1.27 to 3.43 ; P = .004 and 41 % vs 23 % at week 52 ; OR , 2.26 ; 95 % CI , 1.33 to 3.86 ; P = .003 ) . Conclusions and Relevance Among patients with rheumatoid arthritis previously treated with anti-TNF drugs but with inadequate primary response , a non-TNF biologic agent was more effective in achieving a good or moderate disease activity response at 24 weeks than was the second anti-TNF medication . Trial Registration clinical trials.gov Identifier : NCT01000441
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 .