Background: Little is known about effectiveness of certolizumab (CTZ) in clinical practice, especially in patients with inadequate response to prior biologics.

Objectives: To estimate the survival rate of CTZ in RA, PsA or SpA cohorts from the registry BIOPURE. Secondary endpoint was the changes of clinical outcomes from baseline at 6 and 12 months for each disease.

Methods: We analyzed longitudinal data of consecutive patients, affected with RA, PsA or SpA starting a treatment with CTZ recorded into the web-based Apulian registry BIOPURE. Demographic and disease related characteristics were collected at baseline, 6 and 12 months. Drug survival was evaluated by Kaplan-Meier life table analysis. Estimates hazard ratios (HRs, 95% confidence intervals (CI)) of drug discontinuation adjusted for patient’s demographics, disease characteristics and prior biologic treatments were computed by Cox-regression models. Differences of DAS28, DAPSA and BASDAI among baseline, 6 and 12 months were estimated by T-test.

Results: 506 patients were included in this analysis ( table 1 ). Global mean survival time (95% CI) was 58 (52-64) months. Drug survival rate was significantly higher in RA (71.1%) than in PsA (63.5%, p=0.001), while SpA showed 67.5% ( Figure 1 ). Naïve-CTZ patients showed higher survival rates than biologic-inadequate responder (Bio-IR) patients in PsA (naïve 78.4% vs 56.9%, p=0.02), but not in RA (76.9% vs 64.1%, p=0.08), or SpA (73.7% vs 64.8%, p=0.84). The only weak predictor of drug discontinuation was age at baseline for SpA patients (HR 1.04 (95% CI:1.005-1.007) p=0.02) ( Figure 1 ). No baseline covariate, including sex, cDMARDs co-therapy and biologic-naïve status, was found to be associated with CTZ discontinuation for RA and PsA cohorts. A significant improvement of clinical outcomes from baseline was seen at 6 and 12 months, regardless prior biologic therapies. In RA DAS28 dropped from 3.95 ±1.5 to 2.77 ±1.3 at 6 months (p=0.0001) and 2.55 ±1.3 at 12 months (p= 0.0001). In PsA DAPSA decreased from 19.1 ±10 to 10.8 ±8 at 6 months (p=0.0001) and 9.6 ±7 at 12 months (p=0.0001). In SpA DAS28 reduced from 3.66 ±1.4 to 2.85 ±1.3 at 6 months (p=0.0001) and 2.55 ±1.1 at 12 months (p=0.0001). Additionally, in SpA BASDAI dropped from 5.3 ±1.6 to 3.8 ±2.3 at 6 months (p=0.0001) and 2.8 ±1.8 at 12 months (p=0.0001).

Conclusion: In real-life settings CTZ has shown a good effectiveness also in Bio-IR patients. Unlike other TNF-inhibitors, the clinical response and the survival rate were also meaningful in RA patients.

Disclosure of Interests: Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Nicola Maruotti Speakers bureau: Pfizer, Angelo Semeraro Speakers bureau: Sanofi, Roche, AbbVie, BMS, MSD, Novartis, Romano Bucci Speakers bureau: Pfizer, Sanofi, MSD, BMS, Giorgio Carlino Speakers bureau: Pfizer, Janssen, AbbVie, MSD, BMS., Leonardo Santo Consultant of: AbbVie, MSD, Novartis UCB outside this work, Speakers bureau: AbbVie, MSD, Novartis UCB outside this work, Laura Quarta: None declared, Carmelo Zuccaro Consultant of: MSD, AbbVie, Novartis, Pfizer, Janssen outside this work, Speakers bureau: MSD, AbbVie, Novartis, Pfizer, Janssen outside this work, Giuseppina Santacesaria: None declared, Marco Fornaro: None declared, Francesco Paolo Cantatore: None declared