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New findings from the TRANSIT study were presented today at the 20th European Academy of Dermatology and Venereology (EADV) congress, which showed treatment with STELARA® (ustekinumab) is well-tolerated and effective in patients with moderate to severe plaque psoriasis inadequately responsive to methotrexate therapy. Health-related quality of life was also significantly improved according to the study results reported.
The TRANSIT study, a 52 week, open-label, phase IV study of 489 patients, was designed to compare two methods of transitioning patients from methotrexate to ustekinumab. The first was discontinuation of methotrexate with immediate initiation of ustekinumab and the second was initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over four weeks. Results up to week 16 were presented today at the EADV congress.
The primary endpoint of the TRANSIT study was the proportion of patients experiencing at least 1 treatment-emergent adverse event through week 12 in arm 1 versus arm 2. The number and types of adverse events were similar in the two treatment arms. Serious adverse events were infrequent regardless of the transition strategy: 2.9% of patients in the methotrexate immediate cessation arm versus 2.0% of patients in the methotrexate gradual withdrawal arm. Substantial improvement in efficacy was also observed above and beyond the results patients had achieved on methotrexate, which all patients had been receiving for at least 8 consecutive weeks prior to baseline, and which was considered to be inadequately effective. Through week 12, the majority of patients in both arms achieved a Psoriasis Global Assessment (PGA) rating of 'cleared' or 'minimal' (65.3% in the methotrexate immediate cessation arm and 69.5% in the methotrexate gradual withdrawal arm). The median Psoriasis Area and Severity Index (PASI) score decreased from approximately 15 in both arms at baseline to 2.9 in the methotrexate immediate cessation arm versus 2.8 in the methotrexate gradual withdrawal arm.
Improvements in health-related quality of life, as assessed by the Dermatology Life Quality Index (DLQI), were observed as early as week four in both arms of the study. Over the study period of 16 weeks, the mean improvement in DLQI was demonstrated by a reduction from 8.0 in the immediate cessation arm and 9.0 in the gradual withdrawal arm to a score of 1.0 in both arms, a clinically meaningful improvement in health-related quality of life.Substantial improvement in the EuroQOL-5D Visual Analogue Scale (EQ-5D VAS) was also observed in both arms.
"Until now there has been very limited data on how to safely and effectively transition patients with moderate to severe plaque psoriasis from conventional systemic agents to biologics," said Professor Carle Paul, University of Toulouse, France and one of the lead investigators for the TRANSIT study. "Results from the TRANSIT study are important because they further advance our understanding of biologics, not just in terms of efficacy, safety and tolerability, but also health-related quality of life. The health-related quality of life improvements are particularly notable given that patients were already being treated with methotrexate when they entered the study, and over a quarter of patients included in the study had been previously treated with other biologic therapies."
Also presented at EADV were findings from pooled analyses of the ongoing ustekinumab psoriasis clinical development programme (which includes the Phase 2 trial, and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT trials). Data showed that the safety profile of ustekinumab and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. More than 1100 patients had been treated for at least three years with ustekinumab and more than 600 patients had been treated for at least four years, representing a total of nearly 6800 patient years (PY).
"Biological therapies are a valuable advancement in the treatment of moderate to severe psoriasis. To support dermatologists in their decision-making about the most suitable treatment option for patients, it is important to have long-term data on available therapies. This pooled 4-year safety data provides a growing and significant body of evidence about the role ustekinumab can play in the management of this chronic, life-long condition", said Professor Christopher Griffiths, University of Manchester, UK, and lead trial investigator for the ACCEPT study.
The TRANSIT study, a 52 week, open-label, phase IV study of 489 patients, was designed to compare two methods of transitioning patients from methotrexate to ustekinumab. The first was discontinuation of methotrexate with immediate initiation of ustekinumab and the second was initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over four weeks. Results up to week 16 were presented today at the EADV congress.
The primary endpoint of the TRANSIT study was the proportion of patients experiencing at least 1 treatment-emergent adverse event through week 12 in arm 1 versus arm 2. The number and types of adverse events were similar in the two treatment arms. Serious adverse events were infrequent regardless of the transition strategy: 2.9% of patients in the methotrexate immediate cessation arm versus 2.0% of patients in the methotrexate gradual withdrawal arm. Substantial improvement in efficacy was also observed above and beyond the results patients had achieved on methotrexate, which all patients had been receiving for at least 8 consecutive weeks prior to baseline, and which was considered to be inadequately effective. Through week 12, the majority of patients in both arms achieved a Psoriasis Global Assessment (PGA) rating of 'cleared' or 'minimal' (65.3% in the methotrexate immediate cessation arm and 69.5% in the methotrexate gradual withdrawal arm). The median Psoriasis Area and Severity Index (PASI) score decreased from approximately 15 in both arms at baseline to 2.9 in the methotrexate immediate cessation arm versus 2.8 in the methotrexate gradual withdrawal arm.
Improvements in health-related quality of life, as assessed by the Dermatology Life Quality Index (DLQI), were observed as early as week four in both arms of the study. Over the study period of 16 weeks, the mean improvement in DLQI was demonstrated by a reduction from 8.0 in the immediate cessation arm and 9.0 in the gradual withdrawal arm to a score of 1.0 in both arms, a clinically meaningful improvement in health-related quality of life.Substantial improvement in the EuroQOL-5D Visual Analogue Scale (EQ-5D VAS) was also observed in both arms.
"Until now there has been very limited data on how to safely and effectively transition patients with moderate to severe plaque psoriasis from conventional systemic agents to biologics," said Professor Carle Paul, University of Toulouse, France and one of the lead investigators for the TRANSIT study. "Results from the TRANSIT study are important because they further advance our understanding of biologics, not just in terms of efficacy, safety and tolerability, but also health-related quality of life. The health-related quality of life improvements are particularly notable given that patients were already being treated with methotrexate when they entered the study, and over a quarter of patients included in the study had been previously treated with other biologic therapies."
Also presented at EADV were findings from pooled analyses of the ongoing ustekinumab psoriasis clinical development programme (which includes the Phase 2 trial, and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT trials). Data showed that the safety profile of ustekinumab and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. More than 1100 patients had been treated for at least three years with ustekinumab and more than 600 patients had been treated for at least four years, representing a total of nearly 6800 patient years (PY).
"Biological therapies are a valuable advancement in the treatment of moderate to severe psoriasis. To support dermatologists in their decision-making about the most suitable treatment option for patients, it is important to have long-term data on available therapies. This pooled 4-year safety data provides a growing and significant body of evidence about the role ustekinumab can play in the management of this chronic, life-long condition", said Professor Christopher Griffiths, University of Manchester, UK, and lead trial investigator for the ACCEPT study.