FDA News

FDA approves Taltz for psoriatic arthritis in adults

Peter Salzmann

The FDA has approved ixekizumab injections of 80 mg/mL for the treatment of adults with active psoriatic arthritis, according to a press release from its manufacturer.

Ixekizumab (Taltz, Eli Lilly) was previously approved by the FDA in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy.

“The FDA approval of Taltz for adults with active psoriatic arthritis is an important milestone in Lilly’s march to immunology leadership,” Peter Salzmann, MD, vice president of immunology at Eli Lilly, told Healio Rheumatology. “Two phase 3 studies demonstrated not only that Taltz is safe and effective for patients with active psoriatic arthritis who had never been treated with a biologic disease-modifying anti-rheumatic drug, but also for patients with active psoriatic arthritis who have failed or were intolerant to an anti-tumor necrosis factor inhibitor. We are excited to offer a new treatment option that provides significant improvement in joint symptoms and can help both patients and their healthcare providers meet treatment goals.”

According to the company release, Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, the company said. Taltz inhibits the release of pro-inflammatory cytokines and chemokines, and can be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

According to the release, the FDA determined the efficacy and safety of Taltz using findings from two randomized, double-blind, placebo-controlled Phase 3 studies — SPIRIT-P1 and SPIRIT-P2 — which included more than 670 adult patients with active PsA.

SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug. Meanwhile, SPIRIT-P2 evaluated the treatment’s safety and efficacy compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors.

In both studies, all patients were required to have a diagnosis of active PsA for at least 6 months, as well as at least three tender and three swollen joints. Inadequate responders — defined by blinded tender and swollen joint count criteria— at 16 weeks received rescue therapy and were analyzed as non-responders. The primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response, a 20% reduction in a composite measure of disease activity as defined by the American College of Rheumatology.

According to the Eli Lilly, patients in both studies treated with Taltz reported significant improvement in joint symptoms, as measured by ACR20, compared with placebo. At 24 weeks, 58% of patients treated with Taltz in SPIRIT-P1 achieved ACR20, compared with 30% among those given a placebo. In the SPIRIT-P2 study, 53% of patients treated with Taltz achieved ACR20, compared with 20% in the placebo group.

According to the company, physicians should not prescribe Taltz for patients with a previous serious hypersensitivity reaction to ixekizumab, such as anaphylaxis, or to any of the excipients. In addition, Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. For additional safety and prescribing information, click here.

“For patients with PsA, treatment goals often include improvement in joint symptoms,” Philip Mease, MD, director of the rheumatology clinical research division at the Swedish Medical Center in Seattle, said in the release. “Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors.” – by Jason Laday

Disclosure: Salzmann reports he is vice president of immunology at Eli Lilly. Mease reports receiving consulting fees from Eli Lilly.

Peter Salzmann

The FDA has approved ixekizumab injections of 80 mg/mL for the treatment of adults with active psoriatic arthritis, according to a press release from its manufacturer.

Ixekizumab (Taltz, Eli Lilly) was previously approved by the FDA in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy.

“The FDA approval of Taltz for adults with active psoriatic arthritis is an important milestone in Lilly’s march to immunology leadership,” Peter Salzmann, MD, vice president of immunology at Eli Lilly, told Healio Rheumatology. “Two phase 3 studies demonstrated not only that Taltz is safe and effective for patients with active psoriatic arthritis who had never been treated with a biologic disease-modifying anti-rheumatic drug, but also for patients with active psoriatic arthritis who have failed or were intolerant to an anti-tumor necrosis factor inhibitor. We are excited to offer a new treatment option that provides significant improvement in joint symptoms and can help both patients and their healthcare providers meet treatment goals.”

According to the company release, Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, the company said. Taltz inhibits the release of pro-inflammatory cytokines and chemokines, and can be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

According to the release, the FDA determined the efficacy and safety of Taltz using findings from two randomized, double-blind, placebo-controlled Phase 3 studies — SPIRIT-P1 and SPIRIT-P2 — which included more than 670 adult patients with active PsA.

SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug. Meanwhile, SPIRIT-P2 evaluated the treatment’s safety and efficacy compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors.

In both studies, all patients were required to have a diagnosis of active PsA for at least 6 months, as well as at least three tender and three swollen joints. Inadequate responders — defined by blinded tender and swollen joint count criteria— at 16 weeks received rescue therapy and were analyzed as non-responders. The primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response, a 20% reduction in a composite measure of disease activity as defined by the American College of Rheumatology.

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According to the Eli Lilly, patients in both studies treated with Taltz reported significant improvement in joint symptoms, as measured by ACR20, compared with placebo. At 24 weeks, 58% of patients treated with Taltz in SPIRIT-P1 achieved ACR20, compared with 30% among those given a placebo. In the SPIRIT-P2 study, 53% of patients treated with Taltz achieved ACR20, compared with 20% in the placebo group.

According to the company, physicians should not prescribe Taltz for patients with a previous serious hypersensitivity reaction to ixekizumab, such as anaphylaxis, or to any of the excipients. In addition, Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. For additional safety and prescribing information, click here.

“For patients with PsA, treatment goals often include improvement in joint symptoms,” Philip Mease, MD, director of the rheumatology clinical research division at the Swedish Medical Center in Seattle, said in the release. “Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors.” – by Jason Laday

Disclosure: Salzmann reports he is vice president of immunology at Eli Lilly. Mease reports receiving consulting fees from Eli Lilly.