Eli Lilly and Company (NYSE: LLY) has announced that the majority of patients with active psoriatic arthritis (PsA) treated with Taltz® (ixekizumab) exhibited either no progression or minimal progression of radiographic structural joint damage through 52 weeks of treatment. Detailed results from the extension period of the SPIRIT-P1 trial will be presented in an oral presentation today during the Annual European Congress of Rheumatology (EULAR) 2017, taking place June 14-17, in Madrid.
“Psoriatic arthritis is a chronic, progressive disease that if left untreated, can result in permanent, structural joint damage and impaired physical function,” said Phillip Mease, M.D., Swedish Medical Center and University of Washington, Seattle, United States. “Results from the extension period of SPIRIT-P1 are encouraging and provide new information on the potential for Taltz, if approved, to address unmet needs of patients living with this challenging disease.”
During the 24-week, double-blind period of the SPIRIT-P1 study, patients with active PsA who had never received a biologic disease-modifying antirheumatic drug (bDMARD) were treated with either 80 mg of Taltz once every two weeks or every four weeks (following a 160-mg starting dose), or adalimumab at the approved dose of 40 mg every two weeks or placebo. Adalimumab was employed as an active control in the SPIRIT-P1 study and was not powered for comparison with Taltz treatment groups. Following completion of the 24-week treatment period, patients were re-randomized to receive 80 mg of Taltz every two weeks or four weeks to evaluate response rates during the extension period through 52 weeks.
Patients treated with Taltz at both dosing regimens experienced either no progression or minimal radiographic progression of structural joint damage as measured by the change from baseline in the van der Heijde modified Total Sharp Score (mTSS) for PsA at 52 weeks. No progression or minimal radiographic progression of structural joint damage was also observed for patients who switched from placebo or adalimumab to either dosing regimen of Taltz after the 24-week treatment period.
During the extension period of SPIRIT-P1, the incidence of treatment-emergent adverse events was greater with Taltz treatment compared with placebo. The most common (≥4 percent) treatment-emergent adverse events observed in all patients treated with Taltz were nasopharyngitis and injection site reaction. These events are consistent with those reported in the Phase 3 studies of Taltz for the treatment of moderate-to-severe plaque psoriasis (UNCOVER 1, 2, 3).
“For patients living with psoriatic arthritis, it is important to work with a specialist to find a treatment that manages both the signs and symptoms of the disease, but also helps prevent further joint damage,” said Dr. Lotus Mallbris, global brand development leader, Taltz, Eli Lilly and Company. “One year following the approval of Taltz for moderate-to-severe plaque psoriasis in the U.S., Canada and Europe, we are excited to present new data to rheumatologists from around the world at the Annual European Congress of Rheumatology (EULAR) 2017.”
Lilly has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz as a treatment of adult patients with active PsA. Taltz is approved for adult patients with active PsA in Japan. Submissions to other regulatory agencies around the world are expected later this year.
Indications and Usage
Taltz® (ixekizumab) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.
Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.
Most common adverse reactions ( > 1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
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