1 Recommendations
1.1 Guselkumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and:
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have had at least 1 biological DMARD, or
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tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).
Guselkumab is recommended only if the company provides it according to the commercial arrangement. Active psoriatic arthritis is defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints.
1.2 Assess the response to guselkumab from 16 weeks. Stop guselkumab at 24 weeks if the psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If the PsARC response is not adequate but there is a Psoriasis Area and Severity Index (PASI) 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.
1.3 Take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the PsARC and make any adjustments needed.
1.4 Take into account how skin colour could affect the PASI score and make any adjustments needed.
1.5 These recommendations are not intended to affect treatment with guselkumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
People with active psoriatic arthritis that is not controlled well enough with 2 conventional DMARDs are usually offered biological DMARDs. Many of these are already recommended by NICE for treating psoriatic arthritis. Guselkumab is a biological DMARD.
Clinical evidence shows that guselkumab is effective compared with placebo, but it has not been compared directly with other biological DMARDs for treating psoriatic arthritis. An indirect comparison suggests that guselkumab is as effective as the biological DMARDs secukinumab and ixekizumab, particularly for skin symptoms.
For people who have had 2 conventional DMARDs and at least 1 biological DMARD, guselkumab's cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources.
For people who have had 2 conventional DMARDs and for whom TNF-alpha inhibitors are contraindicated, the costs and benefits are similar to those of other treatments recommended by NICE.