Ixekizumab (Taltz) has been recommended by NICE for use as a treatment option for adults with active psoriatic arthritis (PsA), after inadequate response to DMARDs (disease modifying antirheumatic drugs).
The NICE guidance states that ixekizumab alone, or with methotrexate, is recommended for treating active psoriatic arthritis in adults, only if:
- It is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis:
- The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and
- The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs (DMARDs), administered either individually or in combination
- Treatment should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules.
- The person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after the first 12 weeks; or
- TNF alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis)
- Ixekizumab is only recommended if the company provides it according to the commercial arrangement.
Dr. Arash Tahbaz, Senior Medical Director, Eli Lilly and Company, the pharmaceutical behind ixekizumab, said: “Up to 30 per cent of people with psoriasis will also develop psoriatic arthritis, a severe form of inflammatory arthritis that can cause swollen, stiff and painful joints. It can reduce physical function and lead to a reduction in quality of life so we are pleased that NICE is able to recommend this new treatment option.”
Additionally, the NICE guidance states:
1.2 Assess the response to ixekizumab after 16 weeks of treatment. Only continue treatment if there is clear evidence of response, defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response but whose PsARC response does not justify continuing treatment should be assessed by a dermatologist, to determine whether continuing treatment is appropriate based on skin response (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis, recommendation 1.3).
1.3 When using the PsARC, healthcare professionals should take into account any physical, sensory or learning disabilities or communication difficulties that could affect a person's responses to components of the PsARC and make any adjustments they consider appropriate.
1.4 When using the PASI, healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.
1.5 These recommendations are not intended to affect treatment with ixekizumab 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.
Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor, a protein which plays a key role in psoriatic arthritis. Ixekizumab was granted EU marketing authorisation (MA) for Taltz (ixekizumab) in January 2018, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.
The European Commission Marketing Authorisation for ixekizumab in PsA was based on findings from a Phase 3 clinical trial program. The efficacy and safety of ixekizumab was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies– SPIRIT-P1 and SPIRIT-P2 – which included 780 adult patients with active PsA.
The medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. Any side effects a patient may get should be reported. See www.mhra.gov.uk/yellowcard for how to report side effects.