MADRID (FRONTLINE MEDICAL NEWS) – The anti–interleukin-17 drug ixekizumab, already on the U.S. market for treating psoriasis, showed efficacy and safety for treating psoriatic arthritis in patients who previously failed to respond to or tolerate a tumor necrosis factor inhibitor in a pivotal, phase 3 trial with 363 patients.

Treatment of patients with psoriatic arthritis (PsA) with ixekizumab (Taltz) led to improvements, compared with placebo, in arthritis, physical function, and psoriasis. These patients were unresponsive to or intolerant of a tumor necrosis factor inhibitor (TNFi) at rates similar to previously reported response rates for PsA patients who were TNFi naive, Peter Nash, MD , said at the European Congress of Rheumatology.

A published report with the data presented by Dr. Nash also recently appeared ( Lancet. 2017;389[10086]:2317-27 ).

The results showed “no unexpected” safety findings, with safety profiles consistent with what has been seen in psoriasis patients and in PsA patients in a prior phase 3 study, said Dr. Nash, a rheumatologist at Queensland University in Brisbane, Australia.

Based in part on the results from this trial , as well as results from a companion phase 3 trial that enrolled PsA patients naive to a TNFi ( Ann Rheum Dis. 2017 Jan; 6[1]:79-87 ), the company that markets ixekizumab, Eli Lilly, filed an application with the Food and Drug Administration in early 2017 to have a new label indication for PsA, said a company spokeswoman.

“At least half of PsA patients don’t get at least a 20% improvement [an ACR20 response] on a TNFi, and so they are looking for something else,” explained Mark C. Genovese, MD , professor of medicine and director of the Rheumatology Clinic at Stanford (Calif.) University and a coinvestigator on the trial reported by Dr. Nash. “There is pent up demand” for an alternative to a TNFi for treating PsA, Dr. Genovese said in an interview.

The primary endpoint of the Study of Ixekizumab in Participants With Active Psoriatic Arthritis ( SPIRIT-P2 ) was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24, reached by 53% of patients who received an 80 mg subcutaneous injection of ixekizumab every 4 weeks and by 20% of patients on placebo, a statistically significant difference. The finding that ixekizumab improved half the patients who failed TNFi treatment is “a tremendous opportunity” for the alternative drug class, Dr. Genovese commented.

The finding also sets ixekizumab apart from secukinumab (Cosentyx), another interleukin-17 inhibitor that already has FDA approval for treating PsA but that has not been specifically tested in PsA patients who failed or didn’t tolerate a TNFi, he noted.

The SPIRIT-P2 results also showed superior outcomes for patients treated with an ixekizumab injection once every 2 or 4 weeks, compared with placebo, by several secondary measures, including ACR50 and ACR70 rates and minimal disease activity. The ACR70 rate after 24 weeks on treatment was 23% with a dose of ixekizumab every 4 weeks and none with placebo. Minimal disease activity was reached by about a quarter of patients on either dosage of the active drug and by 3% of patients on placebo.

Despite the apparent role for ixekizumab when TNFi treatment fails, the TNFi drug class remains the clear first-line choice for PsA patients who are starting a biological drug for the first time. Not only do the TNFis have a much longer and more extensive track record but they also generally receive better insurance coverage that minimizes out-of-pocket expenses for patients, Dr. Genovese said.

SPIRIT-P2 was sponsored by Eli Lilly, the company that markets ixekizumab. Dr. Nash has been a speaker for or consultant to and has received research funding from Eli Lily and for several other companies. Dr. Genovese has been a consultant to and has received research funding from Eli Lilly, AbbVie, Astellas, Galapagos, Pfizer, and Vertex.

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