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LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
REPORTING FROM RHEUMATOLOGY 2018
Key clinical point: Ixekizumab has multiple beneficial effects in patients with psoriatic arthritis previously treated with biologics.
Major finding: Mean HAQ-DI score changes (baseline to week 24) were –0.4 and –0.6 with ixekizumab (80 mg every 2 or 4 weeks) and –0.2 for placebo (P less than or equal to .001).
Study details: SPIRIT-P2: A randomized, double-blind, placebo-controlled phase 3 trial of ixekizumab in 363 biologic-experienced patients.
Disclosures: Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
Source: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.