One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment: the TRANSIT randomized trial in moderate-to-severe plaque psoriasis

K Reich, L Puig, C Paul, K Kragballe, T Luger, J Lambert, S Chimenti, G Girolomoni, J-F Nicolas, E Rizova, M Brunori, S Mistry, P Bergmans, J Barker, TRANSIT Investigators, Anthony Ormerod

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Abstract

BACKGROUND: There are limited long-term, 'real-world' data on ustekinumab, or the effect of dose adjustment in suboptimal responders.

OBJECTIVES: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.

METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.

RESULTS: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0·4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved a PASI score ≤ 5, and 341 patients (77%) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40).

CONCLUSIONS: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.

Original languageEnglish
Pages (from-to)435-444
Number of pages10
JournalBritish Journal of Dermatology
Volume170
Issue number2
DOIs
Publication statusPublished - Feb 2014

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Psoriasis
Methotrexate
Safety
Therapeutics
Ustekinumab

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One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment : the TRANSIT randomized trial in moderate-to-severe plaque psoriasis. / Reich, K; Puig, L; Paul, C; Kragballe, K; Luger, T; Lambert, J; Chimenti, S; Girolomoni, G; Nicolas, J-F; Rizova, E; Brunori, M; Mistry, S; Bergmans, P; Barker, J; TRANSIT Investigators; Ormerod, Anthony.

In: British Journal of Dermatology, Vol. 170, No. 2, 02.2014, p. 435-444.

Research output: Contribution to journalArticle

Reich, K, Puig, L, Paul, C, Kragballe, K, Luger, T, Lambert, J, Chimenti, S, Girolomoni, G, Nicolas, J-F, Rizova, E, Brunori, M, Mistry, S, Bergmans, P, Barker, J, TRANSIT Investigators & Ormerod, A 2014, 'One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment: the TRANSIT randomized trial in moderate-to-severe plaque psoriasis' British Journal of Dermatology, vol. 170, no. 2, pp. 435-444. https://doi.org/10.1111/bjd.12643
Reich, K ; Puig, L ; Paul, C ; Kragballe, K ; Luger, T ; Lambert, J ; Chimenti, S ; Girolomoni, G ; Nicolas, J-F ; Rizova, E ; Brunori, M ; Mistry, S ; Bergmans, P ; Barker, J ; TRANSIT Investigators ; Ormerod, Anthony. / One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment : the TRANSIT randomized trial in moderate-to-severe plaque psoriasis. In: British Journal of Dermatology. 2014 ; Vol. 170, No. 2. pp. 435-444.
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title = "One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment: the TRANSIT randomized trial in moderate-to-severe plaque psoriasis",
abstract = "BACKGROUND: There are limited long-term, 'real-world' data on ustekinumab, or the effect of dose adjustment in suboptimal responders.OBJECTIVES: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75{\%} improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.RESULTS: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9{\%}) discontinued before week 52 (0·4{\%} due to adverse events). At week 52 (in the overall population), 369 patients (83{\%}) achieved a PASI score ≤ 5, and 341 patients (77{\%}) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43{\%}) and 15/31 (48{\%}) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40).CONCLUSIONS: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.",
author = "K Reich and L Puig and C Paul and K Kragballe and T Luger and J Lambert and S Chimenti and G Girolomoni and J-F Nicolas and E Rizova and M Brunori and S Mistry and P Bergmans and J Barker and {TRANSIT Investigators} and Anthony Ormerod",
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TY - JOUR

T1 - One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment

T2 - the TRANSIT randomized trial in moderate-to-severe plaque psoriasis

AU - Reich, K

AU - Puig, L

AU - Paul, C

AU - Kragballe, K

AU - Luger, T

AU - Lambert, J

AU - Chimenti, S

AU - Girolomoni, G

AU - Nicolas, J-F

AU - Rizova, E

AU - Brunori, M

AU - Mistry, S

AU - Bergmans, P

AU - Barker, J

AU - TRANSIT Investigators

AU - Ormerod, Anthony

N1 - © 2013 British Association of Dermatologists.

PY - 2014/2

Y1 - 2014/2

N2 - BACKGROUND: There are limited long-term, 'real-world' data on ustekinumab, or the effect of dose adjustment in suboptimal responders.OBJECTIVES: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.RESULTS: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0·4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved a PASI score ≤ 5, and 341 patients (77%) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40).CONCLUSIONS: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.

AB - BACKGROUND: There are limited long-term, 'real-world' data on ustekinumab, or the effect of dose adjustment in suboptimal responders.OBJECTIVES: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.RESULTS: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0·4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved a PASI score ≤ 5, and 341 patients (77%) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40).CONCLUSIONS: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.

U2 - 10.1111/bjd.12643

DO - 10.1111/bjd.12643

M3 - Article

VL - 170

SP - 435

EP - 444

JO - British Journal of Dermatology

JF - British Journal of Dermatology

SN - 0007-0963

IS - 2

ER -