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Br J Dermatol. 2015;172(5):1395-406. doi: 10.1111/bjd.13551. Epub 2015 Apr 2.

Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial.

Author information

1
Innovaderm Research, Montreal, QC, Canada.
2
Aarhus University Hospital, Aarhus, Denmark.
3
Department of Medicine/Dermatology, UCLA School of Medicine, Los Angeles, CA, U.S.A.
4
Salford Royal Hospital, Manchester Academic Health Science Centre, University of Manchester, Manchester, U.K.
5
Skin and Cancer Foundation Inc., The University of Melbourne, Carlton, Vic., Australia.
6
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
7
Pfizer Inc, Groton, CT, U.S.A.
8
Pfizer Inc, New York, NY, U.S.A.
9
Pfizer Inc, Collegeville, PA, U.S.A.

Abstract

BACKGROUND:

Tofacitinib is an oral Janus kinase inhibitor being investigated for the treatment of moderate-to-severe plaque psoriasis.

OBJECTIVES:

To compare outcomes following tofacitinib withdrawal with outcomes of continuation.

METHODS:

In this phase 3 study (NCT01186744), patients received tofacitinib 5 mg (n = 331) or 10 mg (n = 335) twice daily for 24 weeks. The patients who achieved both ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75) score from baseline and Physician's Global Assessment (PGA) of 'clear' or 'almost clear' (PGA response) received a placebo (withdrawal) or the previous dose. At relapse (> 50% reduction in the PASI improvement during initial treatment) or week 40, the patients received the initial dose.

RESULTS:

Initial treatment: 33·5% and 55·2% achieved both PASI 75 and PGA responses with tofacitinib 5 and 10 mg twice daily, respectively, making them eligible for the treatment-withdrawal period. Withdrawal: 56·2%, 62·3%, 23·3% and 26·1% maintained PASI 75 responses with tofacitinib 5, 10 mg, placebo (5 mg) and placebo (10 mg) twice daily, respectively; 49·9%, 63·9%, 22·9% and 18·0% maintained PGA responses; and 92·3%, 93·0%, 32·8% and 42·9% did not relapse. Elevations in low-density lipoprotein-cholesterol levels following initial treatment (mean increase: 8·71 mg dL(-1) with 5 mg twice daily, 10·26 mg dL(-1) with 10 mg twice daily) were reversed upon withdrawal. Retreatment: 36·8% and 61·0% of patients who relapsed achieved PASI 75 responses with tofacitinib 5 or 10 mg after 16 weeks; 44·8% and 57·1% regained PGA responses.

CONCLUSIONS:

Patients who received continuous treatment maintained a response more effectively when compared with placebo recipients. Safety profiles were comparable in both the continuous treatment group and retreatment group. Of those patients who relapsed, up to 60% recaptured a response with tofacitinib.

PMID:
25418186
DOI:
10.1111/bjd.13551
[Indexed for MEDLINE]

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