Introduction: The therapeutic use of monoclonal antibodies (mAbs) has significantly increased since the first mAb was introduced. Despite their therapeutic benefits, mAbs have been accompanied by a rise in adverse effects, affecting various organ systems including the skin. This systematic review consolidates the current literature on the incidence, characteristics, and management of adverse dermatological events (ADEs) post-mAb treatment, focusing on Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme (EM), and fixed drug eruption (FDE).
Methods: A comprehensive PubMed search from 1980 to January 2024 included studies on mAbs causing SJS, TEN, EM, or FDE in humans. Screening was conducted using Covidence, and data were extracted on demographics, mAb details, rash characteristics, and treatment.
Results: Of the initial 2002 articles, 29 met the inclusion criteria, highlighting 31 cases of ADEs. The onset of these rashes was delayed, often occurring significantly after starting mAb therapy, with a mean onset time considerably longer than that associated with traditional drugs. Additionally, neither patient sex nor concurrent medication use affected the likelihood of developing these reactions.
Conclusion: This review underscores the prolonged timeline for the onset of ADEs from mAbs, distinct from reactions induced by traditional drugs, aligning with the characteristics of progressive immunotherapy-related mucocutaneous eruption. The lack of correlation with patient sex or concurrent medications reaffirms the inherent risk of mAbs. These findings highlight the need for clinicians to monitor and educate patients about the potential for delayed dermatological reactions from mAb treatment to ensure timely management and better outcomes.
Keywords: Adverse drug reaction; Biologicals; Dermatology; Immunology; Monoclonal antibody.
Monoclonal antibodies (mAbs) are specialized treatments used for conditions such as cancer and autoimmune diseases since their introduction in 1984. While beneficial, mAbs can cause severe skin reactions, known as adverse dermatological events (ADEs). These reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme (EM), and fixed drug eruption (FDE). These ADEs are not well documented in the literature. This systematic review aimed to understand these skin reactions caused by mAbs. We analyzed studies published between 1980 and January 2024, focusing on cases where mAbs led to SJS, TEN, EM, or FDE. We identified 29 articles describing 31 cases of ADEs. The reactions often occurred long after starting mAb therapy. Neither the patient’s sex nor the use of other medications seemed to influence the likelihood of these reactions. Our review showed that skin reactions from mAbs appeared later than those from traditional drugs, likely because the longer time mAbs stay in the body. These delayed reactions align with a condition known as progressive immunotherapy-related mucocutaneous eruption. It is crucial for doctors to recognize and manage these delayed reactions differently from true SJS/TEN reactions which are more immediate and severe. In conclusion, doctors should be aware of the potential for delayed skin reactions in patients receiving mAbs. By educating patients and enhancing monitoring, healthcare providers can ensure timely management of these adverse effects, thereby improving patient outcomes while allowing them to benefit from these advanced treatments.
© 2025 The Author(s). Published by S. Karger AG, Basel.