Steven Cohen, MD

The summary of three major observations about the treatment of psoriasis with biologics reported at the Annual Congress of the European Academy of Dermatology and Venereology contains a series of disturbing caveats that may be obscured by the use of scientific lingo.

I am prompted to attempt making these observations more accessible to the clinician because the underlying message seems paradoxical.

The psoriasis area severity index (PASI) and the physician global assessment (PGA) are metrics that place numerical values on the extent of psoriasis in a patient (or study subject enrolled in a research protocol). Higher values describe more extensive and morbid disease.

• Is PASI 90 becoming the new PASI 75? Since the newest anti-interleukin-17 biologics dramatically reduce the time to clearance while maximally suppressing active disease (by either metric), it is curious that Dr. Bruce Strober of the University of Connecticut, Farmington, warns, "the danger is that if you cross a line, you may be unable to precisely regulate the level of immunosuppression in some patients." The implication is that improved efficacy might be "too much of a good thing."

• Clinical trials of the new biologics underestimate the extent and range of adverse phenomena associated with these drugs. Dr Hervé Bachelez of Saint Louis University Hospital, Paris, cites a study of patients enrolled in the Spanish psoriasis registry, Biobadaderm, describing marked underestimation of serious adverse events (SAE) by comparing cohorts of patients who received biologics despite being disqualified from clinical trials with those participating in the trials. Referring to systemic therapy with biologics, Dr. Bachelez cautions, "Basically, you can expect some safety issues in real life." The cautionary message is beware improved treatment outcomes in clinical trials that likely mask the extent and degree of SAEs in the general population after the drug is marketed.

• Patients who experience clearing (as measured by improved PASI scores) continue to have suboptimal dermatology quality of life (DLQI) indices. Dr. Peter Van de Kerkhof of Radboud University, Nijmegen, the Netherlands, reported this conclusion from his own study as the basis for another warning that the increasing therapeutic efficacy of new biologics might fall short with respect to patient satisfaction.

The observations in this article advance a prematurely negative long-term forecast with the increasing efficacy of new biologics. These drugs have been a game-changer for the treatment of psoriasis and psoriatic arthritis ... and the improved efficacy of the newer biologics hold even greater promise. Until the data are available suggesting otherwise, it is important to affirm that the jury is still out.

Dr. Steven Cohen is chief of the division of dermatology in the department of medicine at Montefiore Medical Center, N.Y. He is a recognized authority in the fields of environmental and occupational dermatology and psoriasis, with more than 100 publications to his credit. Dr. Cohen is a Fellow of the American Academy of Dermatology, Society for Investigative Dermatology, New York Academy of Medicine, and the American College of Occupational and Environmental Medicine.

The summary of three major observations about the treatment of psoriasis with biologics reported at the Annual Congress of the European Academy of Dermatology and Venereology contains a series of disturbing caveats that may be obscured by the use of scientific lingo.

I am prompted to attempt making these observations more accessible to the clinician because the underlying message seems paradoxical.

The psoriasis area severity index (PASI) and the physician global assessment (PGA) are metrics that place numerical values on the extent of psoriasis in a patient (or study subject enrolled in a research protocol). Higher values describe more extensive and morbid disease.

• Is PASI 90 becoming the new PASI 75? Since the newest anti-interleukin-17 biologics dramatically reduce the time to clearance while maximally suppressing active disease (by either metric), it is curious that Dr. Bruce Strober of the University of Connecticut, Farmington, warns, "the danger is that if you cross a line, you may be unable to precisely regulate the level of immunosuppression in some patients." The implication is that improved efficacy might be "too much of a good thing."

• Clinical trials of the new biologics underestimate the extent and range of adverse phenomena associated with these drugs. Dr Hervé Bachelez of Saint Louis University Hospital, Paris, cites a study of patients enrolled in the Spanish psoriasis registry, Biobadaderm, describing marked underestimation of serious adverse events (SAE) by comparing cohorts of patients who received biologics despite being disqualified from clinical trials with those participating in the trials. Referring to systemic therapy with biologics, Dr. Bachelez cautions, "Basically, you can expect some safety issues in real life." The cautionary message is beware improved treatment outcomes in clinical trials that likely mask the extent and degree of SAEs in the general population after the drug is marketed.

• Patients who experience clearing (as measured by improved PASI scores) continue to have suboptimal dermatology quality of life (DLQI) indices. Dr. Peter Van de Kerkhof of Radboud University, Nijmegen, the Netherlands, reported this conclusion from his own study as the basis for another warning that the increasing therapeutic efficacy of new biologics might fall short with respect to patient satisfaction.

The observations in this article advance a prematurely negative long-term forecast with the increasing efficacy of new biologics. These drugs have been a game-changer for the treatment of psoriasis and psoriatic arthritis ... and the improved efficacy of the newer biologics hold even greater promise. Until the data are available suggesting otherwise, it is important to affirm that the jury is still out.

Dr. Steven Cohen is chief of the division of dermatology in the department of medicine at Montefiore Medical Center, N.Y. He is a recognized authority in the fields of environmental and occupational dermatology and psoriasis, with more than 100 publications to his credit. Dr. Cohen is a Fellow of the American Academy of Dermatology, Society for Investigative Dermatology, New York Academy of Medicine, and the American College of Occupational and Environmental Medicine.

The summary of three major observations about the treatment of psoriasis with biologics reported at the Annual Congress of the European Academy of Dermatology and Venereology contains a series of disturbing caveats that may be obscured by the use of scientific lingo.

I am prompted to attempt making these observations more accessible to the clinician because the underlying message seems paradoxical.

The psoriasis area severity index (PASI) and the physician global assessment (PGA) are metrics that place numerical values on the extent of psoriasis in a patient (or study subject enrolled in a research protocol). Higher values describe more extensive and morbid disease.

• Is PASI 90 becoming the new PASI 75? Since the newest anti-interleukin-17 biologics dramatically reduce the time to clearance while maximally suppressing active disease (by either metric), it is curious that Dr. Bruce Strober of the University of Connecticut, Farmington, warns, "the danger is that if you cross a line, you may be unable to precisely regulate the level of immunosuppression in some patients." The implication is that improved efficacy might be "too much of a good thing."

• Clinical trials of the new biologics underestimate the extent and range of adverse phenomena associated with these drugs. Dr Hervé Bachelez of Saint Louis University Hospital, Paris, cites a study of patients enrolled in the Spanish psoriasis registry, Biobadaderm, describing marked underestimation of serious adverse events (SAE) by comparing cohorts of patients who received biologics despite being disqualified from clinical trials with those participating in the trials. Referring to systemic therapy with biologics, Dr. Bachelez cautions, "Basically, you can expect some safety issues in real life." The cautionary message is beware improved treatment outcomes in clinical trials that likely mask the extent and degree of SAEs in the general population after the drug is marketed.

• Patients who experience clearing (as measured by improved PASI scores) continue to have suboptimal dermatology quality of life (DLQI) indices. Dr. Peter Van de Kerkhof of Radboud University, Nijmegen, the Netherlands, reported this conclusion from his own study as the basis for another warning that the increasing therapeutic efficacy of new biologics might fall short with respect to patient satisfaction.

The observations in this article advance a prematurely negative long-term forecast with the increasing efficacy of new biologics. These drugs have been a game-changer for the treatment of psoriasis and psoriatic arthritis ... and the improved efficacy of the newer biologics hold even greater promise. Until the data are available suggesting otherwise, it is important to affirm that the jury is still out.

Dr. Steven Cohen is chief of the division of dermatology in the department of medicine at Montefiore Medical Center, N.Y. He is a recognized authority in the fields of environmental and occupational dermatology and psoriasis, with more than 100 publications to his credit. Dr. Cohen is a Fellow of the American Academy of Dermatology, Society for Investigative Dermatology, New York Academy of Medicine, and the American College of Occupational and Environmental Medicine.