Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate: a randomized clinical trial (TRANSIT)

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

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics.

OBJECTIVES: The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.

METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.

RESULTS: Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2·9% and 2·4% had a serious AE, and 1·2% and 0·4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58% and 62% of patients achieved a 75% reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16.

CONCLUSIONS: Ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

Original languageEnglish
Pages (from-to)425-434
Number of pages10
JournalBritish Journal of Dermatology
Volume170
Issue number2
DOIs
Publication statusPublished - Feb 2014

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Psoriasis
Methotrexate
Randomized Controlled Trials
Safety
Ustekinumab
Biological Factors
Dermatology
Quality of Life

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Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate : a randomized clinical trial (TRANSIT). / Paul, C; Puig, L; Kragballe, K; Luger, T; Lambert, J; Chimenti, S; Girolomoni, G; Nicolas, J-F; Rizova, E; Lavie, F; Mistry, S; Bergmans, P; Barker, J; Reich, K; TRANSIT Investigators; Ormerod, Anthony.

In: British Journal of Dermatology, Vol. 170, No. 2, 02.2014, p. 425-434.

Research output: Contribution to journalArticle

Paul, C, Puig, L, Kragballe, K, Luger, T, Lambert, J, Chimenti, S, Girolomoni, G, Nicolas, J-F, Rizova, E, Lavie, F, Mistry, S, Bergmans, P, Barker, J, Reich, K, TRANSIT Investigators & Ormerod, A 2014, 'Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate: a randomized clinical trial (TRANSIT)', British Journal of Dermatology, vol. 170, no. 2, pp. 425-434. https://doi.org/10.1111/bjd.12646
Paul, C ; Puig, L ; Kragballe, K ; Luger, T ; Lambert, J ; Chimenti, S ; Girolomoni, G ; Nicolas, J-F ; Rizova, E ; Lavie, F ; Mistry, S ; Bergmans, P ; Barker, J ; Reich, K ; TRANSIT Investigators ; Ormerod, Anthony. / Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate : a randomized clinical trial (TRANSIT). In: British Journal of Dermatology. 2014 ; Vol. 170, No. 2. pp. 425-434.
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abstract = "BACKGROUND: Limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics.OBJECTIVES: The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.RESULTS: Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61{\%} and 65{\%} of patients experienced an AE, 2·9{\%} and 2·4{\%} had a serious AE, and 1·2{\%} and 0·4{\%} had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58{\%} and 62{\%} of patients achieved a 75{\%} reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16.CONCLUSIONS: Ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.",
author = "C Paul and L Puig and K Kragballe and T Luger and J Lambert and S Chimenti and G Girolomoni and J-F Nicolas and E Rizova and F Lavie and S Mistry and P Bergmans and J Barker and K Reich and {TRANSIT Investigators} and Anthony Ormerod",
note = "{\circledC} 2013 British Association of Dermatologists. Funding sources This clinical trial was sponsored by Janssen Pharmaceutica NV. Funding for medical writing support and assistance in collating author contributions was provided by Janssen.",
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TY - JOUR

T1 - Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate

T2 - a randomized clinical trial (TRANSIT)

AU - Paul, C

AU - Puig, L

AU - Kragballe, K

AU - Luger, T

AU - Lambert, J

AU - Chimenti, S

AU - Girolomoni, G

AU - Nicolas, J-F

AU - Rizova, E

AU - Lavie, F

AU - Mistry, S

AU - Bergmans, P

AU - Barker, J

AU - Reich, K

AU - TRANSIT Investigators

AU - Ormerod, Anthony

N1 - © 2013 British Association of Dermatologists. Funding sources This clinical trial was sponsored by Janssen Pharmaceutica NV. Funding for medical writing support and assistance in collating author contributions was provided by Janssen.

PY - 2014/2

Y1 - 2014/2

N2 - BACKGROUND: Limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics.OBJECTIVES: The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.RESULTS: Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2·9% and 2·4% had a serious AE, and 1·2% and 0·4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58% and 62% of patients achieved a 75% reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16.CONCLUSIONS: Ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

AB - BACKGROUND: Limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics.OBJECTIVES: The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.METHODS: Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.RESULTS: Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2·9% and 2·4% had a serious AE, and 1·2% and 0·4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58% and 62% of patients achieved a 75% reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16.CONCLUSIONS: Ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

U2 - 10.1111/bjd.12646

DO - 10.1111/bjd.12646

M3 - Article

C2 - 24116959

VL - 170

SP - 425

EP - 434

JO - British Journal of Dermatology

JF - British Journal of Dermatology

SN - 0007-0963

IS - 2

ER -