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

Volumn 170, Issue 2, 2014, Pages 435-444

  Reich, K ^a,b   Puig, L ^c   Paul, C ^d   Kragballe, K ^e   Luger, T ^f   Lambert, J ^g   Chimenti, S ^h   Girolomoni, G ⁱ   Nicolas, J F ^j   Rizova, E ^k   Brunori, M ^k   Mistry, S ^l   Bergmans, P ^m   Barker, J ⁿ  

^a DERMATOLOGIKUM HAMBURG   (Germany)

^b UNIVERSITY OF GÖTTINGEN   (Germany)

^c UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^d SERVICE DE PNEUMOLOGIE   (France)

^e AARHUS UNIVERSITY HOSPITAL   (Denmark)

^f UNIVERSITY OF MÜNSTER   (Germany)

^g GHENT UNIVERSITY   (Belgium)

^h TOR VERGATA UNIVERSITY HOSPITAL   (Italy)

ⁱ UNIVERSITY OF VERONA   (Italy)

^j UNIVERSITÉ DE LYON   (France)

^k Janssen Cilag   (France)

^l Janssen Cilag BV ^*  (United Kingdom)

^m Janssen Cilag BV Netherlands   (Netherlands)

ⁿ KING'S COLLEGE LONDON   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODIES, MONOCLONAL, HUMANIZED; DERMATOLOGIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG SUBSTITUTION; FEMALE; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; PSORIASIS; TREATMENT OUTCOME;

EID: 84894235102     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/bjd.12643     Document Type: Article

References (20)

1. European Medicines Agency. Ustekinumab. Summary of Product Characteristics, updated September 2013. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000958/WC500058513.pdf (last accessed 11 November 2013).
2. Paul C, Puig L, Kragballe K, et al,. Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate: a randomized clinical trial (TRANSIT). Br J Dermatol 2014; 170: 425-33.
3. Leonardi CL, Kimball AB, Papp KA, et al,. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008; 371: 1665-74.
4. Papp KA, Langley RG, Lebwohl M, et al,. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008; 371: 1675-84.
5. Gourraud PA, Le Gall C, Puzenat E, et al,. Why statistics matter: limited inter-rater agreement prevents using the Psoriasis Area and Severity Index as a unique determinant of therapeutic decision in psoriasis. J Invest Dermatol 2012; 132: 2171-5.
6. Finlay AY, Khan GK,. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-16.
7. EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
8. Zigmond AS, Snaith RP,. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983; 67: 361-70.
9. Opel D, Economidi A, Chan D, et al,. Two cases of hepatitis B in patients with moderate to severe psoriasis with ustekinumab. J Drugs Dermatol 2012; 11: 1498-501.
10. Cardiff University. Dermatology Life Quality Index (DLQI). Frequently Asked Questions (FAQs), 2012. Available at: http://www.dermatology.org.uk/quality/dlqi/quality-dlqi-faqs.html (last accessed 11 November 2013).
11. EuroQol Group. Measuring self-reported population health: an international perspective based on EQ-5D, 2004. Available at: http://www.euroqol.org/fileadmin/user-upload/Documenten/PDF/Books/Measuring-Self-Reported-Population-Health-An-International-Perspective-based-on-EQ-5D.pdf (last accessed 11 November 2013).
12. Bjelland I, Dahl AA, Haug TT, Neckelmann D,. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002; 52: 69-77.
13. Reich K, Langley RG, Lebwohl M, et al,. Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies. Br J Dermatol 2011; 164: 862-72.
14. Lebwohl M, Leonardi C, Griffiths CE, et al,. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (part I of II): results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. J Am Acad Dermatol 2012; 66: 731-41.
15. Gordon KB, Papp KA, Langley RG, et al,. Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials. J Am Acad Dermatol 2012; 66: 742-51.
16. Mrowietz U, Kragballe K, Reich K, et al,. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res 2011; 303: 1-10.
17. Pathirana D, Ormerod AD, Saiag P, et al,. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol 2009; 23 (Suppl. 2): 1-70.
18. Heller MM, Wong JW, Nguyen TV, et al,. Quality-of-life instruments: evaluation of the impact of psoriasis on patients. Dermatol Clin 2012; 30: 281-91.
19. Khilji FA, Gonzalez M, Finlay AY,. Clinical meaning of change in Dermatology Life Quality Index scores. Br J Dermatol 2002; 147 (Suppl. 62): 50.
20. Hongbo Y, Thomas CL, Harrison MA, et al,. Translating the science of quality of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol 2005; 125: 659-64.