Background: Monoclonal antibodies encompass an increasingly important treatment for a variety of dermatologic conditions including hidradenitis suppurativa (HS). The high failure rate and cost of anti-tumor necrosis alpha (TNF-α) agents and emergence of biologic treatments critically warrant treatment strategies that identify treatment failures early and optimize therapy. This review’s primary objective is to understand the current literature on biologic therapeutic drug monitoring (TDM) used in chronic inflammatory diseases and apply this knowledge to future dermatologic studies and treatment.
Methods: Randomized controlled trials (RCTs) or high-quality retrospective analyses of RCTs investigating the outcomes of biologic TDM were identified between January 1979 and January 2020 within the PubMed/MEDLINE database using keywords: "biologic," "therapeutic drug monitoring," and "randomized controlled trial," combined with common medical conditions for which biologics are prescribed: "rheumatoid arthritis," "inflammatory bowel disease," "psoriasis," "Crohn’s," "ulcerative colitis," "vasculitis," and "hidradenitis suppurativa." The methods and findings of each study were compared.
Results: Three RCTs were included all examining TDM of TNF-α inhibitors in inflammatory bowel disease (IBD). Two studied TDM of infliximab, and one adalimumab. An additional high-quality retrospective analysis of an infliximab RCT captured in our search was also included. Two of the three RCTs (TAXIT and PAILOT) found proactive TDM superior to clinically based dosing and reactive TDM, respectively. The third RCT (TAILORX) found no significant difference between proactive and reactive TDM.
Conclusion: TDM of anti-TNF-α biologics in IBD has demonstrated success through RCTs. Knowledge gained from these studies applies to dermatologic treatment. J Drugs Dermatol. 2023;22(5): doi:10.36849/JDD.6671.