Anti-adalimumab antibodies in psoriasis: lack of clinical utility and laboratory evidence.

Abstract

OBJECTIVE:

Adalimumab has proven effective in psoriasis; however, secondary failure may result from the drug's immunogenicity. Prevalence data on the immunogenicity of biologicals, and of adalimumab in particular, are highly variable. We investigated the prevalence of anti-adalimumab antibodies and the association with clinical indexes and tumour necrosis factor α (TNFα) serum levels in psoriatic patients.

DESIGN:

Case-control, longitudinal.

SETTING:

Single centre.

PARTICIPANTS:

Patient groups: I (n=20) receiving biological therapies after switching from adalimumab; II (n=30) ongoing adalimumab therapy; III (n=30) novel adalimumab therapy; IV (n=15) biological therapies other than adalimumab.Healthy subjects: (group V; n=15) never treated with immunosuppressants or biologicals.

INTERVENTIONS:

All groups were tested at enrolment. Group II was also tested at 12 months, and group III at 1, 3, and 6 months.

PRIMARY AND SECONDARY OUTCOME MEASURES:

Standard clinical evaluations (Psoriasis Area Severity Index (PASI)), blood samples and two-site ELISA-based measurement of serum adalimumab trough levels, anti-adalimumab antibodies and TNFα.

RESULTS:

The false-positive rate was 23% for adalimumab detection and 22% for anti-adalimumab antibodies in patients naïve to adalimumab. Spurious positivity for anti-adalimumab antibodies (one-time-point positivity in group III during follow-up) accounted for 33% of the total. The prevalence of anti-drug antibodies was highest (87%) in group I patients. No correlations were found between the presence of anti-adalimumab antibodies or adalimumab levels and changes in PASI scores.

CONCLUSIONS:

High variability of results, high prevalence of false-positives and lack of association between anti-adalimumab antibodies and TNFα level/PASI score limit this assay's usefulness. Accurate clinical evaluation is key to early identification of treatment failures.

• Authors: G Lombardi, S Perego, V Sansoni, M Diani, G Banfi, G Altomare
• Journal: BMJ open (BMJ Open) Vol. 6 Issue 12 Pg. e011941 (12 09 2016) ISSN: 2044-6055 [Electronic] England
• PMID: 27940624 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Chemical References

• Anti-Inflammatory Agents
• Antibodies
• Biomarkers
• Tumor Necrosis Factor-alpha
• Adalimumab

Topics

• Adalimumab (immunology, therapeutic use)
• Adult
• Anti-Inflammatory Agents (immunology, therapeutic use)
• Antibodies (blood)
• Biomarkers (blood)
• Case-Control Studies
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy, immunology)
• Severity of Illness Index
• Treatment Failure
• Tumor Necrosis Factor-alpha (blood)