Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

Abstract

Objectives: To evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.

Methods: Consecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.

Results: 608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).

Conclusions: In a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

Keywords: antirheumatic agents; arthritis; biological therapy; psoriatic.

Figure 1

Minimal disease activity (MDA) (percentage, %) of overall population and after their subdivision in two groups, according to the lines of the disease-modifying antirheumatic drugs treatment (group A, or bio-naïve vs group B, or non-bio-naïve patients) (A), dosage of secukinumab (150 vs 300 mg/injection) (B), gender (C) and body mass index (BMI) (overweight vs normal weight) (D). ns, not statistically significant; PsA, psoriatic arthritis.

Figure 2

Drug survival in the overall population and after their subdivision in two groups, according to the lines of the disease-modifying antirheumatic drugs treatment (group A, or bio-naïve vs group B, or non-bio-naïve patients) (A), dosage of secukinumab (150 vs 300 mg/injection) (B), gender (C) and body mass index (BMI) (overweight vs normal weight) (D).