An observer blind randomised controlled trial to compare the clinical and health economic benefits of prescribing adalimumab instead of methotrexate in patients with moderate psoriasis with psoriasis area and severity index (PASI) scores of ≥5 and <10
Psoriasis
1. 80 mg loading, then 1 week later, and subsequently 2-weekly throughout the trial, 40 mg adalimumab subcutaneous injections (intervention) 2. Weekly 17.5 mg methotrexate subcutaneous injections (control)
1. Adults aged ≥ 18 years of age with a diagnosis of moderate chronic plaque psoriasis, as defined by PASI score ≥5 and <10 2. Able and willing to provide written informed consent 3. Able to self-administer subcutaneous therapy 4. Willing to use effective contraception if woman of childbearing potential
1. Treatment with methotrexate or adalimumab within 6 months prior to randomisation 2. Prior use of any biologic therapy for psoriasis, psoriatic arthritis, inflammatory bowel disease, or other inflammatory joint diseases 3. Patients who are currently receiving phototherapy, have received phototherapy within the 4 weeks prior to randomisation, or who will require phototherapy during the trial treatment period are excluded. 4. Topical treatment except emollients and mild topical steroids within 2 weeks prior of randomisation* 5. Use of other systemic drugs for the treatment of psoriasis within 12 weeks prior of randomisation* 6. Actively attempting to conceive, are pregnant, or breastfeeding 7. Male participants trying to conceive 8. Co-existing health problems that contraindicate immunosuppression, including tuberculosis (TB), chronic viral infectious diseases, active malignancy 9. Any conditions associated with worsening due to TNF inhibition including multiple sclerosis personal history or in a first-degree relative, personal history of lupus, personal history of moderate or severe heart failure 10. Patients with a significant current neuropsychiatric illness; or any lifetime history of suicidal ideation, suicidal behaviour, or suicide attempts; or are clinically deemed to have an elevated suicide risk by the investigator. *Patients will be allowed to use emollients and mild topical steroids such as hydrocortisone or clobetasone butyrate (Eumovate) throughout trial inclusion. Stronger topical steroids such as betamethasone (including the use of dovobet) or calcineurin antagonists (such as topical tacrolimus or phototherapy) are not permitted. A 2-week washout period will be needed for stronger topical treatments** and 12 weeks for other systemic drugs for PSO. **Tacrolimus ointment 0.1% or 0.03% will be allowed as a rescue medication for facial psoriasis if needed.