Israel Medical Association Journal

Background: Clinical research is needed to identify patients with axial spondyloarthritis (axSpA) who are more likely to be responsive to interleukin (IL)-17 inhibition.

Objectives: To evaluate short-term efficacy of secukinumab in the management of axSpA.

Method: Twenty-one patients (7 males, 14 females) with axSpA were consecutively treated with secukinumab. Laboratory and clinical assessments were based on erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and at a 3 month follow-up visit.

Results: The study was comprised of 21 patients. Both BASDAI and ASDAS-CRP showed a statistically significant reduction between the baseline and the 3 month visit (P < 0.0001 and P = 0.0005, respectively). During the laboratory assessment, ESR showed a significant decrease (P = 0.008) while CRP improvement did not reach statistical significance (P = 0.213). No statistical significance was observed between patients treated with secukinumab 150 mg vs. 300 mg in BASDAI (P=0.99), ASDAS-CRP (P = 0.69), ESR (P = 0.54), and CRP (P = 0.56). No significant differences emerged between the BASDAI (P = 0.15), ASDAS-CRP (P = 0.09), and CRP (P = 0.15) rates in biologic-naïve patients and those previously failing tumor necrosis factor-α inhibition. Conversely, ESR decrease was significantly higher in the biologic-naïve subgroup (P = 0.01). No adverse events were reported.

Conclusions: Secukinumab has proven remarkable short-term effectiveness, regardless of the biologic treatment line. A dosage of 150 mg proved to be appropriate in the clinical and laboratory management of axSpA.

Background: Biological agents for anti-tumor necrosis factor-α therapy have revolutionized treatments for autoimmune diseases; however, approximately 20% of rheumatology and 40% of gastroenterology patients do not respond to the therapy, or they show reduced drug efficacy because of anti-drug antibody (ADA) formation.

Objectives: To evaluate laboratory tools for individual monitoring of infliximab therapy and the relationship between ADA and infliximab serum levels, ADA and clinical response, and ADA and autoantibodies.

Methods: Our study comprised patients treated with infliximab and affected by selected rheumatology and gastroenterology diseases. Sera were analyzed for infliximab, total-anti-drug antibodies (Total-ADA), and free-anti-drug antibodies (Free-ADA) serum levels and for the detection of specific autoantibodies.

Results: We analyzed 73 patients. Total-ADA were detected in 26 rheumatology and 21 gastroenterology patients. Serum infliximab levels were significantly lower in Total-ADA positive patients (P = 0.01 for rheumatology group, P = 0.02 for gastroenterology group). A lack of response was observed in 7 rheumatology and 15 gastroenterology samples. Total-ADA serum levels were statistically significantly higher in patients with treatment failure in both groups (P = 0.01 and P = 0.001, respectively). There was no significant association between the presence of Total-ADA and other autoantibodies. Free-ADA were detected in only 27 rheumatology patients. Results showed a significant correlation with clinical outcome (P = 0.006).

Conclusions: The correlation with clinical response suggests that the presence of ADA could interfere with efficacy of therapy. The tests for monitoring therapy may be an important tool to assist clinicians in early detection and prevention of therapy failure.