Biologics in dermatology: An integrated review

Abstract

The advent of biologics in dermatologic treatment armentarium has added refreshing dimensions, for it is a major breakthrough. Several agents are now available for use. It is therefore imperative to succinctly comprehend their pharmacokinetics for their apt use. A concerted endeavor has been made to delve on this subject. The major groups of biologics have been covered and include: Drugs acting against TNF-α, Alefacept, Ustekinumab, Rituximab, IVIG and Omalizumab. The relevant pharmacokinetic characteristics have been detailed. Their respective label (approved) and off-label (unapproved) indications have been defined, highlighting their dosage protocol, availability and mode of administration. The evidence level of each indication has also been discussed to apprise the clinician of their current and prospective uses. Individual anti-TNF drugs are not identical in their actions and often one is superior to the other in a particular disease. Hence, the section on anti-TNF agents mentions the literature on each drug separately, and not as a group. The limitations for their use have also been clearly brought out.

An Update on Medical Treatment Options for Hidradenitis Suppurativa

“…Ustekinumab is a human monoclonal antibody that binds to the p40 subunits of IL-12 and IL-23, preventing them from binding to their receptor [81]. To date, eight HS patients have been treated with 45 mg ustekinumab subcutaneously, mostly at weeks 0, 4, and 12, followed by every 3 months.…”

Pharmacokinetic characteristics of therapeutic antibodies

“…Thus, several therapeutic antibodies (TAs) have been established especially in the treatment of chronic inflammatory and oncologic diseases. They have undergone comprehensive testing/characterization with respect to their effectiveness and safety . Thus, along with a plethora of conventional drugs – small molecules – as well as other biologics (recombinant proteins, fusion proteins, Fab fragments), they constitute routine therapeutic options for a wide range of diseases, with increasing relevance and an ever growing number of indications.…”

“…In dermatology, these agents are predominantly used in chronic inflammatory diseases such as psoriasis, including psoriasis arthritis, chronic spontaneous urticaria, lupus erythematosus, and oncologic indications such as lymphoma, malignant melanoma, and basal cell carcinoma, as well as a number of off‐label indications (pyoderma gangrenosum, sarcoidosis, toxic epidermal necrolysis, hidradenitis suppurativa (inverse acne), and others.) . In the coming years, additional TAs against new target antigens as well as a variety of biosimilars are expected to obtain approval and reach the market .…”

Pharmakokinetische Besonderheiten von therapeutischen Antikörpern

“…Die Entwicklungen der letzten Jahre haben deutlich gemacht, dass insbesondere deren hohe Bindungsspezifität an lösliche oder zellgebundene Zielstrukturen einen großen therapeutischen Nutzen begründen kann . So wurden mehrere therapeutische Antikörper (TAK) insbesondere bei chronisch‐entzündlichen sowie bei onkologischen Erkrankungen etabliert sowie hinsichtlich ihrer Wirksamkeit und Sicherheit umfänglich charakterisiert . Diese zählen damit, neben einer Vielzahl von konventionellen Arzneistoffen (KAM), sogenannten small molecules , sowie anderen Biologika (rekombinante Proteine, Fusionsproteine, Fab‐Fragmente), zu den Routineoptionen des therapeutischen Managements einer Vielzahl von Erkrankungen mit zunehmender Relevanz und Indikationsvielfalt.…”

“…sowie eine Vielzahl von Off‐Label‐Indikationen (Pyoderma gangraenosum, Sarkoidose, toxisch epidermale Nekrolyse, Acne inversa etc.) . Zudem ist in den nächsten Jahren damit zu rechnen, dass weitere TAK gegen neue Zielantigene sowie eine Vielzahl von Biosimilars Marktreife und Zulassung erlangen .…”