In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for patients with rheumatoid arthritis (RA). In other news, the U.S. Food and Drug Administration (FDA) has approved ixekizumab to treat active psoriatic arthritis (PsA).
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New Auto-Injector for Etanercept
In September 2017, the FDA approved the Enbrel (etanercept) Mini with AutoTouch, a new delivery system designed to administer a single dose of etanercept.1 The delivery system, which was awarded the Arthritis Foundation’s Ease of Use Commendation, is now available for patient use in the U.S .
The AutoTouch is a reusable autoinjector for patients with RA. It features an ergonomic handle, a needle that stays hidden during injection, a skin-placement sensor, a speed switch with three injection speeds, a progress bar and a speaker.
The AutoTouch uses 50 mg/mL single-dose, prefilled cartridges of etanercept. This new etanercept formulation had significantly lower mean injection site pain than the current formulation. A Phase 3b multicenter, randomized, double-blind, crossover study in adults with moderate to severe RA or PsA was conducted to assess injection site pain associated with this modified etanercept formulation.
The results: Study participants indicated they experienced a significant reduction in injection site pain. Adverse events were similar to those seen in prior studies in adults with moderate to severe RA and PsA.
FDA Approves Ixekizumab for Active PsA
In March 2016, the FDA first approved ixekizumab (Taltz) as an 80 mg/mL injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Recently, ixekizumab was approved to treat adults with active PsA. The agent may be administered in monotherapy or taken in combination with a conventional disease-modifying anti-rheumatic drug (DMARD), such as methotrexate.1
The safety and efficacy of ixekizumab was established during two randomized, double-blind, placebo-controlled Phase 3 studies, SPIRIT-P1 and SPIRIT-P2, in more than 670 adults with active PsA. SPIRIT-P1 was conducted in patients with active PsA who were biologic DMARD therapy naive. SPIRIT-P2 evaluated the efficacy and safety of ixekizumab compared with placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors.
In both studies, patients had to have been diagnosed with active PsA for six or more months and had to have at least three tender and three swollen joints. At Week 16, inadequate responders, who were determined by blinded tender and swollen joint count criteria, received rescue therapy. These patients were then analyzed as non-responders.
In both studies, the primary efficacy endpoint was the proportion of patients achieving an ACR20 response at Week 24. Ixekizumab-treated patients achieved significant improvement in joint symptoms compared with placebo-treated patients. At Week 24 in the SPIRIT-P1 study, 58% of ixekizumab-treated patients compared with 30% of placebo-treated patients achieved ACR20. And in the SPRIT-P2 study, 53% of ixekizumab-treated patients compared with 20% of placebo-treated patients achieved ACR20.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Amgen Inc. Amgen launches the Enbril Mini single-dose, prefilled cartridge with AutoTouch reusable autoinjector that is ergonomically designed for patients. 2017 Nov. 17.
- Eli Lilly and Company. Lilly’s Taltz (ixekizumab) receives U.S. FDA approval for the treatment of active psoriatic arthritis. 2017 Dec 1.