Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
As many as one third of patients show insufficient response to their first TNF inhibitor (TNF-insufficient response, TNF-IR). The lack of efficacy of one anti-TNF drug does not preclude the potential efficacy of another anti-TNF drug. Alternatively, switching to a non-TNF-targeted therapy is also a rationale strategy. These 2 strategies (a second anti-TNF agent or a non-TNF targeted therapy) have only been compared in scarce observational studies in TNF-IR patients. However, no randomized controlled trial has compared the efficacy of a non-TNF-targeted biologic and a second anti-TNF drug in TNF-IR patients. We previously presented the preliminary results at 6 months. We now present the final 12 month-results of the trial.
The “Rotation of anti-TNF Or Change of class of biologic” (ROC) trial (NCT01000441) is a multicenter,investigator-initiated, open, parallel-group, randomized controlled trial. Patients with inadequate response to a first anti-TNF were randomly assigned in a 1:1 ratio to receive a non-TNF-targeted biologic or a second anti-TNF agent. The choice of the biologic prescribed within each randomized group (ie, non-TNF-targeted biologic or a second anti-TNF agent) was left to the treating clinician. The study duration was 48 weeks.
At week 12 (W12), for patients randomized to a non-TNF-targeted biologic (n=146) or a second anti-TNF agent (n=146), 64.2% and 47.8%, respectively, achieved a good or moderate EULAR response (good response: 27.7% and 13.2%, respectively; moderate response: 36.5% and 34.6%, respectively) (OR 2.01, 95% CI [1.23; 3.32], p = 0.005).
At W24 (primary outcome), 69.7% and 52.1%, respectively, achieved a good or moderate EULAR response (good response: 39.4% and 21.1%, respectively; moderate response: 30.3% and 31.0%) (OR 2.12, 95%confidence interval [95% CI] [1.31; 3.46], p=0.003). At W24, DAS28-ESR was lower for patients with the non-TNF-targeted biologic than second anti-TNF drug (difference adjusted to baseline value -0.43, 95% CI [-0.72; ‑0.14], p= 0.004). The proportion with low disease activity was 44.6% and 27.9%, respectively (OR 2.09, 95%CI [1.27; 3.43], p= 0.004).
At W48, 60.0% of patients treated with a non TNF-targeted biologic and 43.2% of those treated with a second anti-TNF were EULAR responders (good response: 37.7% and 21.2%, respectively; moderate response: 22.3 and 22.0%, respectively) (OR 1.97 (95%CI [1.21; 3.24], p = 0.007). DAS28-ESR was lower for patients with the non-TNF-targeted biologic than second anti-TNF drug (difference adjusted to baseline value -0.38, 95% CI [-0.69; ‑0.08], p= 0.013). The proportion with low disease activity was 40.8% and 23.5%, respectively (OR 2.24, 95%CI [1.32; 3.82], p= 0.003). The proportion with DAS28-ESR remission was 26.9% and 13.6%, respectively (OR 2.34, 95% CI [1.24; 4.39], p= 0.009. Ongoing comparison of radiographic progression and safety will be also presented at ACR.
Conclusion: This randomized controlled trial demonstrated a better efficacy of a non-TNF-targeted biologic than a second anti-TNF agent for TNF-IR patients. This superiority was consistent over time and across numerous outcome criteria.
To cite this abstract in AMA style:Gottenberg J, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin A, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist Bouillon S, Lioté F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis Labous E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Perrodeau E, Sibilia J, Ravaud P. In the Multicenter Randomized Controlled Rotation or Change Trial, a Non-TNF Targeted Therapy Has a Higher Efficacy Than a Second Anti-TNF at 3, 6 and 12 Months [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/in-the-multicenter-randomized-controlled-rotation-or-change-trial-a-non-tnf-targeted-therapy-has-a-higher-efficacy-than-a-second-anti-tnf-at-3-6-and-12-months/. Accessed September 19, 2021.
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