Medications in dermatology are safer and more efficient than they used to be

KEYWORDS:

• Dermatology
• drug safety
• biologics
• psoriasis

Advances in our understanding of biologic drugs have yielded revolutionary, highly effective medications in the field of dermatology. In this issue of Expert Opinion on Drug Safety, we consider this vast array of new therapeutics and reveal a fascinating collection of review articles summarizing the newest clinical trial data and safety reports for these dermatologic treatments.

‘How can we manage the safety concerns associated with the increase in biologics for psoriasis?’ provides a thorough analysis of the eleven biologic therapies available for the treatment of moderate-to-severe plaque psoriasis. When prescribing a biologic for psoriasis, establishing a complete understanding of patients’ baseline health may be valuable, as a majority of the side effects associated with these therapeutics are related to comorbidities already present in patients before the initiation of biologic therapy. For instance, one adverse effect of TNF-α inhibitors is the reactivation of latent TB. An adverse effect of IL-17 inhibitors discussed in this issue is a small risk of developing mild-to-moderate mucocutaneous candidiasis [1]. When compared to older systemic non-biologic agents used to treat psoriasis – such as methotrexate, cyclosporine and acitretin – these biologics are associated with far fewer adverse effects [2].

The expensive price of these new biologics may be mitigated somewhat by the development of biosimilars. ‘Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review’ helps clinicians and patients better understand this new class of therapeutics. Biologics are too complex to duplicate. Unlike generic forms of small molecule medications, biosimilars are not exact replicas of the originator (nor are current batches of the originator identical to the original originator) but are extremely similar to their originator biologic on a molecular level. There is no apparent difference in safety and efficacy between originator biologics and their biosimilar counterparts.

This month’s issue also highlights the issue of undertreatment of elderly patients suffering from psoriasis. This undertreatment may be partially due to the limited inclusion of elderly patients in randomized clinical trials for newer biologics in the treatment of psoriasis. Also highlighted in this month’s issue is the safety of using combined therapies for psoriasis and a safety profile of the therapeutics available to dermatologists in the treatment of vitiligo. ‘Safety considerations when using drugs to treat pruritus’ documents the armamentarium of therapeutics available for the treatment of chronic pruritus, one of the most common complaints of dermatologic patients. New treatments are leaving the landscape of immunomodulation and instead are targeting the neuronal system. The opioid pathways have become a promising target in the treatment of uremic itch, and medications targeting the NK-1 receptor are currently undergoing clinical trials for the treatment of atopic dermatitis and prurigo nodularis [3,4].

This special edition explores neurological adverse effects such as meningoencephalitis, myasthenia gravis and peripheral neuropathy associated with the use of checkpoint inhibitors in the treatment of melanoma. These adverse events occur in around 6% of those treated with these drugs, and the identification of these events underscores the importance of multidisciplinary management by oncology and neurology in certain patients using checkpoint inhibitor therapy for the treatment of melanoma [5,6]. Though the abovementioned side effects represent a source of significant morbidity for affected patients, the risk of these side effects using checkpoint inhibitors is perhaps exceeded by the risk of not treating a potentially fatal melanoma.

It takes good judgment to better understand safety of drugs. One of the big issues in drug safety is that it is much easier to assess differences in efficacy than in safety, as a much larger sample size is needed to assess the frequency of rare events. Future registries may be helpful in building a more accurate safety risk assessment, but registries also have their limitations, as there is generally no randomized placebo control group available for comparison.

Another relevant issue in the realm of drug safety is the perception of safety risk by patients, a phenomenon which ultimately affects how adherent patients are to their treatment plan. How patients are presented with drug safety information could potentially have a big impact on their willingness to take and adhere to a particular drug. A patient who reads in a drug insert that one in 1,000 patients will be affected by a severe side effect could have a much different opinion of a drug than a patient who is told by their physician that 999 patients out of 1,000 do not encounter any serious side effects and tolerate the drug well. In short, how patients subjectively perceive a drug’s safety depends on more than just objective safety data.

The increased effectiveness and specificity of newer medications raise some safety issues. This issue of Expert Opinion on Drug Safety presents compelling research showing that many of the newer medications used in dermatology are safer than the therapies previously used. The aforementioned articles do their best to present objective safety data, but it is prudent to remember that our own perceptual biases affect how we will view this evidence.