FDA expands Taltz label to include genital psoriasis

The FDA approved a label update for Taltz 80 mg/mL injection to contain data on psoriasis involving the genital area, according to a press release from Eli Lilly, the product’s manufacturer.

The label change is effective immediately in the United States and is the first approval from the FDA for treating psoriasis in the genital area, the press release stated.

“Up to 63% of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease,” Pete Salzmann, vice president, Lilly Immunology, said in the release. “However, there remains a serious unmet need for patients seeking treatment options. We are proud of this important milestone for Taltz.”

“This news is a significant step in providing patients with more options for treating their disease,” Michael Siegel, PhD, senior vice president of research and clinical affairs, National Psoriasis Foundation, added.

According to the release, the label update was approved based on a randomized, double-blind trial involving 149 patients with plaque psoriasis with minimum body surface area involvement of 1%, a static Physician Global Assessment (sPGA) score of 3 or greater and a sPGA of genitalia score of 3 or greater. Patients were candidates for systemic therapy or phototherapy and were intolerant to or did not respond to at least one topical therapy for the treatment of psoriasis affecting the genital area.

The trial showed that after 12 weeks, Taltz (ixekizumab, Lilly) led to: 

  • 78% of patients having Sexual Function Questionnaire scores of “0” (never) or "1" (rarely) vs. 21% of patients who received placebo;
  • 73% of patients having sPGA genitalia scores of “0” (clear) or “1” (minimal) vs. 8% of those who received placebo;
  • 73% of patients having overall sPGA scores of “0” (clear) or “1” (minimal) vs. 3% of those who received placebo; and
  • 55% of patients having Genital Psoriasis Symptoms Scale Genital Itch scores that improved by four or more points vs. 6% of patients who received placebo.

The company warned that ixekizumab was contraindicated in patients with a previous serious hypersensitivity reaction like anaphylaxis, raised the risk for infection and should not be administered to patients with active tuberculosis infection. Adverse events linked to ixekizumab include injection site reactions, nausea, tinea infections and upper respiratory tract infections. These occurred in 1% or less of patients, the company stated.

“Overall, the safety profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis,” according to the release.

Ixekizumab first received FDA approval in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Last December, ixekizumab was approved for the treatment of active psoriatic arthritis in adults.

Disclosures: Salzmann works for Lilly. Healio Family Medicine was unable to determine Siegel’s relevant financial disclosures prior to publication.

The FDA approved a label update for Taltz 80 mg/mL injection to contain data on psoriasis involving the genital area, according to a press release from Eli Lilly, the product’s manufacturer.

The label change is effective immediately in the United States and is the first approval from the FDA for treating psoriasis in the genital area, the press release stated.

“Up to 63% of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease,” Pete Salzmann, vice president, Lilly Immunology, said in the release. “However, there remains a serious unmet need for patients seeking treatment options. We are proud of this important milestone for Taltz.”

“This news is a significant step in providing patients with more options for treating their disease,” Michael Siegel, PhD, senior vice president of research and clinical affairs, National Psoriasis Foundation, added.

According to the release, the label update was approved based on a randomized, double-blind trial involving 149 patients with plaque psoriasis with minimum body surface area involvement of 1%, a static Physician Global Assessment (sPGA) score of 3 or greater and a sPGA of genitalia score of 3 or greater. Patients were candidates for systemic therapy or phototherapy and were intolerant to or did not respond to at least one topical therapy for the treatment of psoriasis affecting the genital area.

The trial showed that after 12 weeks, Taltz (ixekizumab, Lilly) led to: 

  • 78% of patients having Sexual Function Questionnaire scores of “0” (never) or "1" (rarely) vs. 21% of patients who received placebo;
  • 73% of patients having sPGA genitalia scores of “0” (clear) or “1” (minimal) vs. 8% of those who received placebo;
  • 73% of patients having overall sPGA scores of “0” (clear) or “1” (minimal) vs. 3% of those who received placebo; and
  • 55% of patients having Genital Psoriasis Symptoms Scale Genital Itch scores that improved by four or more points vs. 6% of patients who received placebo.

The company warned that ixekizumab was contraindicated in patients with a previous serious hypersensitivity reaction like anaphylaxis, raised the risk for infection and should not be administered to patients with active tuberculosis infection. Adverse events linked to ixekizumab include injection site reactions, nausea, tinea infections and upper respiratory tract infections. These occurred in 1% or less of patients, the company stated.

“Overall, the safety profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis,” according to the release.

Ixekizumab first received FDA approval in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Last December, ixekizumab was approved for the treatment of active psoriatic arthritis in adults.

Disclosures: Salzmann works for Lilly. Healio Family Medicine was unable to determine Siegel’s relevant financial disclosures prior to publication.