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Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient
Jacques-Eric Gottenberg1, Olivier Brocq2, Aleth Perdriger3
1Department of Rheumatology, National Reference Center for Systemic Autoimmune Diseases, Strasbourg University Hospital, Université de Strasbourg, Strasbourg, France.
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 randomized clinical trial. The final follow-up date was in August 2013.
Interventions:
Patients were randomly 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 randomized 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 randomized 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:
clinicaltrials.gov Identifier: NCT01000441.
Insights
For rheumatoid arthritis patients inadequately responding to TNF inhibitors, a non-TNF biologic agent showed greater efficacy than a second TNF inhibitor. This finding offers guidance for optimizing treatment strategies in RA management.
Area of Science:
- Rheumatology
- Immunology
- Clinical Trials
Background:
- One-third of rheumatoid arthritis (RA) patients exhibit an insufficient response to tumor necrosis factor-alpha (TNF-α) inhibitors.
- Limited guidance exists for selecting subsequent treatments after anti-TNF therapy failure.
Purpose of the Study:
- To compare the efficacy of a non-TNF-targeted biologic (non-TNF) versus a second anti-TNF drug in RA patients with an inadequate response to initial anti-TNF treatment.
Main Methods:
- A 52-week, multicenter, pragmatic, open-label randomized clinical trial involving 300 RA patients with persistent disease activity (DAS28-ESR ≥3.2).
- Patients were randomized (1:1) to receive either a non-TNF biologic or a second anti-TNF agent, with treatment choice within groups left to clinicians.
Main Results:
- At 24 weeks, 69% of patients in the non-TNF group achieved a good/moderate European League Against Rheumatism (EULAR) response compared to 52% in the second anti-TNF group (OR, 2.06; P=.004).
- The non-TNF group demonstrated significantly lower disease activity scores (DAS28-ESR) and higher rates of low disease activity at weeks 24 and 52.
- The non-TNF group showed a statistically significant improvement in EULAR response and disease activity compared to the second anti-TNF group.
Conclusions:
- In RA patients with inadequate response to anti-TNF therapy, non-TNF biologic agents are more effective than a second anti-TNF drug in achieving disease control at 24 weeks.
- This study provides evidence-based guidance for selecting subsequent biologic therapies in RA management.
- The findings support the use of non-TNF biologics as a preferred next step for patients failing initial anti-TNF treatment.
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