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FDA Updates - February 2018

 A brief overview of new drugs approved by the FDA between December 1 and December 14, 2017.

In This Article

Ixekizumab Approved for Adults with Psoriatic Arthritis

On December 1, 2017, the FDA approved ixekizumab (Taltz; Eli Lilly), a humanized interleukin-17A antagonist, for the treatment of adult patients with active psoriatic arthritis (PsA). Ixekizumab was previously approved by the FDA for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or a combination of both in 2016. Ixekizumab is administered via a subcutaneous injection.

“PsA is a chronic, progressive, and painful form of inflammatory arthritis that impacts approximately 1.6 million Americans living with the disease. We are proud to offer a treatment option that can provide improvements in joint symptoms for these patients, further demonstrating Lilly’s overall commitment to immunology,” said Christi Shaw, President, Lilly Bio-Medicines, in a press statement released by the company.

The FDA approval of ixekizumab for the treatment of PsA was based on results from 2 randomized, double-blind, placebo-controlled phase 3 trials—the SPIRIT-P1 trial that compared ixekizumab with placebo in patients with active PsA who were never treated with a biologic disease-modifying antirheumatic drug (DMARD), and the SPIRIT-P2 trial that evaluated the drug in patients with active PsA who had failed treatment with ≤2 tumor necrosis factor inhibitors.

In SPIRIT-P1, 58% of those treated with ixekizumab 80 mg every 4 weeks had achieved a 20% reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR) response at 24 weeks, compared with 30% among those receiving placebo. In SPIRIT-P2, 53% of those treated with ixekizumab reached that end point at 24 weeks, compared with 20% of those receiving placebo.

The most common adverse reactions associated with the use of ixe­kizumab are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.

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Biosimilar to Infliximab Approved for All Eligible Indications of Reference Drug

On December 13, 2017, the FDA approved infliximab-qbtx (Ixifi; Pfizer), a chimeric human-murine monoclonal antibody and tumor necrosis factor blocker, as a biosimilar to infliximab (Remicade; Janssen Biotech) for the treatment of patients with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, PsA, or plaque psoriasis.

The FDA’s approval of infliximab-qbtx was based on evidence that showed the biosimilar’s high degree of similarity with the reference drug, which included data from the phase 3, multinational, randomized, double-blind REFLECTIONS B537-02 clinical trial of patients with moderate-to-severe RA who inadequately responded to methotrexate. This 2-arm, parallel-group study compared the safety, efficacy, and immunogenicity of infliximab-qbtx with that of infliximab plus methotrexate. The primary end point of the trial, an improvement in ACR criteria response ≥20% (ACR20), was met at week 14, and was supported by data at week 30.

The most common adverse reactions (incidence of >10%) associated with the use of infliximab-qbtx include infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

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Tofacitinib and Tofacitinib Extended Release Approved for Adults with Psoriatic Arthritis

On December 14, 2017, the FDA approved tofacitinib (Xeljanz; Pfizer) 5 mg twice daily and tofacitinib extended release 11 mg once daily for the treatment of adults with PsA who are intolerant of or inadequately responded to methotrexate or other DMARDs. Tofacitinib is the first and only Janus kinase inhibitor approved by the FDA for the treatment of patients with moderate-to-severe RA and active PsA.

“Psoriatic arthritis is a complex and progressive disease with an unpredictable course. The approval of Xeljanz is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care,” said Angela Hwang, Global President, Inflammation and Immunology, Pfizer, New York, in a press release by the company.

Data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL)—which comprised 2 pivotal clinical trials, OPAL Broaden and OPAL Beyond—and the ongoing OPAL Balance trial were the basis for this approval.

The 2 primary end points of OPAL Broaden and OPAL Beyond were met; there were statistically significant improvements in ACR20 responses and changes in Health Assessment Questionnaire Disability Index scores from baseline to 3 months in patients receiving tofacitinib 5 mg twice daily plus a nonbiologic DMARD compared with those who received placebo. At 3 months, 50% of the patients receiving tofacitinib 5 mg twice daily in OPAL Broaden achieved an ACR20 response compared with 33% of patients who were taking placebo (P ≤.05). Similarly, 50% of patients receiving tofacitinib 5 mg twice daily in OPAL Beyond achieved an ACR20 response at 3 months compared with 24% of patients taking placebo (P ≤.05).

In both trials, a secondary end point of statistically significant improvement in ACR20 response at week 2 was also seen in patients receiving tofacitinib 5 mg twice daily compared with those taking placebo (OPAL Broaden: 22% vs 6%, respectively [P = .0003]; OPAL Beyond: 27% vs 13%, respectively [P = .0046]).

The safety profile of patients with PsA who received tofacitinib was consistent with that of patients with RA who received the drug. Nasopharyngitis, upper respiratory tract infection, headache, and diarrhea were the most common adverse events associated with the use of tofacitinib, occurring in >3% of patients.

Tofacitinib is recommended for use in combination with nonbiologic DMARDs; administration of the drug in combination with biologic DMARDs or potent immunosuppressants (eg, azathioprine and cyclosporine) is not advocated.

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