Ustekinumab

Red

Brand Name(s):Stelara

Indication:Psoriatic arthritis and Chronic moderate to severe plaque psoriasis (6yrs and above)
Crohn’s disease
(moderately to severely active) Moderately to severely active ulcerative colitis

Rationale:1,2

Considered:Jun-14

Review Date:Feb-25

Comments:
Ustekinumab for treating active psoriatic arthritis (rapid review of technology appraisal guidance 313)
Full guidance available at:http://www.nice.org.uk/guidance/ta340/resources/guidance-ustekinumab-for-treating-active-psoriatic-arthritis-rapid-review-of-technology-appraisal-guidance-313-pdf
June 2015

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Drug Safety Update
Ustekinumab (Stelara): risk of exfoliative dermatitis Full information at:https://www.gov.uk/drug-safety-update/ustekinumab-stelara-risk-of-exfoliative-dermatitis
January 2015

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NICE Guidance TA313 Ustekinumab for treating active psoriatic arthritis: further information can be found at http://publications.nice.org.uk/ustekinumab-for-treating-active-psoriatic-arthritis-ta313

1.1 Ustekinumab is not recommended within its marketing authorisation for treating active psoriatic arthritis, that is, alone or in combination with methotrexate in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

1.2 People currently receiving treatment initiated within the NHS with ustekinumab that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
May 2014
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Ustekinumab is recommended as a treatment option for adults with plaque psoriasis when the following criteria are met.
* The disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) score of 10 or more and a Dermatology Life Quality Index (DLQI) score of more than 10.
* The psoriasis has not responded to standard systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation), or the person is intolerant of or has a contraindication to these treatments.
* The manufacturer provides the 90 mg dose (two 45 mg vials) for people who weigh more than 100 kg at the same total cost as for a single 45 mg vial.

Ustekinumab treatment should be stopped in people whose psoriasis has not responded adequately by 16 weeks after starting treatment. An adequate response is defined as either:
* a 75% reduction in the PASI score (PASI 75) from when treatment started or
* a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in the DLQI score from when treatment started.

When using the DLQI, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the DLQI and make any adjustments they consider appropriate.

NICE TA 180
Ustekinumab for the treatment of adults with moderate to severe psoriasis September 2009