Praluent Hair and Skin Changes: What Alirocumab Actually Does to Your Integument

Does Praluent cause hair loss?

Hair loss is not listed in the Praluent prescribing information. Table 1 of the label pools nine placebo-controlled trials of 2,476 adults given 75 mg or 150 mg every 2 weeks and lists reactions reported in more than 2% of Praluent-treated adults and at least 1 percentage point more often than with placebo: injection-site reactions, influenza, diarrhea, myalgia, muscle spasms and contusion [1]. Alopecia is not one of them. The postmarketing section, which collects reactions reported after approval, has two entries: angioedema and influenza-like illness [1].

The label therefore gives no hair-loss rate to quote.

What skin reactions the label documents

Two categories carry numbers: local reactions at the injection site, and hypersensitivity reactions.

In the pooled 2-week trials, local injection-site reactions — the label describes them as erythema/redness, itching, swelling and pain/tenderness — were reported in 7.2% of alirocumab-treated adults versus 5.1% on placebo [1]. Patients on alirocumab also had more reactions per person, more associated symptoms and reactions of longer average duration than patients on placebo [1]. Stopping treatment because of them was uncommon: 0.2% versus 0.4% [1].

Hypersensitivity reactions as a group were reported in 8.6% of alirocumab-treated adults versus 7.8% on placebo, and the most common single reaction was pruritus, at 1.1% versus 0.4% [1]. Allergic reactions were the leading cause of discontinuation in the hypercholesterolemia trials, 0.6% versus 0.2% [1].

Does the 300 mg dose cause more injection-site reactions?

In a 48-week placebo-controlled trial in which everyone received an injection every 2 weeks, local injection-site reactions were reported in 16.6% of patients on 300 mg every 4 weeks, 9.6% on 75 mg every 2 weeks and 7.9% on placebo [1]. Three patients (0.7%) on the 300 mg regimen stopped treatment because of them, versus none in the other two groups [1].

The 300 mg dose is not one large injection. The label directs two consecutive 150 mg injections at two different sites [1].

Injection-site reactions in the heart-outcome trial and in children

In the cardiovascular outcomes trial — which randomized 18,924 patients who had had an acute coronary syndrome 1 to 12 months earlier [2] and exposed 9,451 to Praluent for a median of 31 months and 9,443 to placebo for a median of 32 months — local injection-site reactions were reported in 3.8% versus 2.1%, and led to permanent discontinuation in 26 patients (0.3%) versus 3 (<0.1%) [1]. In children aged 8 to 17 with heterozygous familial hypercholesterolemia, injection-site reactions were reported in 5% on Praluent versus 0% on placebo over 24 weeks, and no patients stopped treatment because of them [1].

Serious allergic reactions that involve the skin

Hypersensitivity is the label's only warning and precaution. Hypersensitivity vasculitis, angioedema and other hypersensitivity reactions requiring hospitalization have been reported with Praluent, and the label says that if signs or symptoms of a serious hypersensitivity reaction occur, treatment should be discontinued, standard care given, and the patient monitored until signs and symptoms resolve [1]. A history of a serious hypersensitivity reaction to alirocumab or to an excipient in Praluent is a contraindication [1].

Among serious allergic reactions seen in controlled trials, the label names hypersensitivity, nummular eczema and hypersensitivity vasculitis [1]. Angioedema appears in the postmarketing section, where the label notes that voluntary reports come from a population of uncertain size and that a frequency cannot be reliably estimated [1].

In sum, the skin-related events in the label are reactions at the injection site, itching, and serious allergic reactions such as hypersensitivity vasculitis and angioedema [1].