Effectiveness and retention rate of certolizumab pegol in spondyloarthritis. Real life data

Background/Purpose: Certolizumab pegol (CZP) is available for patients with spondyloarthritis (SpA), including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axialSpA). CZP has a different molecular structure, the only Fc free PEGylated antiTNF and monovalent. Thus, CZP represents an alternative for solution NSAIDs refractory patients suffering with SpA. Objective: To evaluate the effectiveness and safety of CZP in a real word setting in SpA patients. Methods: Multicentric cohort of SpA patients treated with CZP according to routine clinical practice. The study was approved by the local Ethics Committee. Maximum follow-up was 12 months. Clinical response was evaluated through BASDAI, ASDAS, BASFI and MASES scores. Safety variables: discontinuation rate. Results: 336 patients with axSpA were included: 56.5% male, mean age 45.8 (±12.1) years, median disease time 4.3 (range 0, 49.5) years, 68.5% HLAB27 positive, never smokers 64.7%. Prior bDMARD exposure: (27.2% none; 37.9% 1, 35% ≥2). At baseline, 36.8% had concomitant csDMARDs. Mean duration on treatment with CZP was 10.3 months. 31.8% of patients had peripheral arthritis and 42.7% enthesitis at baseline. Statistically significant differences in BASDAI, BASFI, ASDAS and MASES were observed at the last visit comparing with baseline (Table 1). In the last observation, 41.0% of the patients achieved BASDAI50, 34% were in ASDAS remission (ASDAS<1.3) and 49% presented a minimal clinical response (ΔASDAS≥ 1.1). Percentage of patients with enthesitis at baseline (42.9%) was reduced to 16.8% at the end of the observation. Finally, 46.3% had resolution of the enthesitis (MASES=0) According to Kaplan-Meier analysis, the drug survival of CZP is 83.3% (Figure1), and similar retention rates were observed independently if CZP were used as monotherapy (82.9%) or in combination with csDMARDs (82.6%). 56/336 (16.7%) withdrawn CZP treatment: 34/336 (10.1%) due to lack of efficacy, 16/336 (4.8%) due to adverse event and 6/336 (1.8%) for other reason. Serious adverse event was found in 23/336 (6.8%) patients. Conclusion: Real life experience from this nationwide rheumatology study, demonstrated the effectiveness and safety of CZP in patients with SpA, with a significant reduction of BASDAI, BASFI, ASDAS and MASES scores.