Adalimumab

Humira® Adalimumab ADA (AbbVie AG)

Biosimilars authorised in CH: Amgevita® (Amgen), Hulio® (Mylan), Hyrimoz® (Sandoz), Idacio® (Fresenius Kabi), Imraldi® (Biogen/ Samsung Bioepis)

Human monoclonal IgG1 antibody that binds soluble and membrane-bound TNF-α

Plaque psoriasis in adults (all TNF-α inhibitors also authorised for psoriatic arthritis)

Authorisation for children: adalimumab from 4 years of age, adalimumab: patients with active moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to systemic antibiotic therapy

Yes

Treatment of adult patients with severe psoriasis (Def. in Swiss S1 Guideline: PASI > 10 and/or BSA > 10 and/or DLQI > 10) in whom UVB and PUVA or one of the following three systemic therapies (ciclosporin, methotrexate, acitretin) have shown no therapeutic success. In the case of infliximab, additional failure of another TNF blocker approved for psoriasis. For adalimumab: patients with active moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to systemic antibiotic therapy

prefilled syringe, prefilled pen

s.c.

Differential blood count, liver enzymes, creatinine, urinalysis, pregnancy test, CRP, screening for HBV, HCV, HIV and TB (optionally including chest X-ray)

Differential blood count, liver enzymes and CRP

At month 3, then every 6 months.

Discontinuation of therapy in the event of non-response after 12 weeks (for HiSCR response of less than 50 %).

80 mg in week 0, 40 mg in week 1, then 40 mg every 2 weeks; once-weekly dosing is possible in case of insufficient response.

Hidradenitis suppurativa: 160 mg in week 0, 80 mg week 2, 40 mg weekly from week 4 or 80 mg every 2 weeks from week 4.

4 - 8 weeks

Week 16: 71–79.6 %

Week 24: 63.3 %

Week 16: 36.5 %

Week 24: 45.7 %

Development of paradoxical psoriasis possible with TNF-α inhibitors. Close monitoring if infections occur. No live vaccinations recommended during therapy.

Humira®: 15,028 (16,184)

Amgevita: 13,000 (14,014)

Hulio®: 13,000 (14,012)

Hyrimoz®: 13,000 (14,012)

Idacio®: 12,792 (13,776)

Imraldi®: 12,194 (13,117)

Possible; a similar clinical response and safety profile to that before interruption can be expected

PASI, (use PrecisePASI for greater accuracy as soon as PASI < 10), BSA and DLQI after 10 and 24 weeks.

6–46 %, association with clinical response

Absolute contraindications: Heart failure NYHA III-IV, active infections, live vaccinations, malignant tumours in the last 5 years, except treated epithelial tumours or cervical dysplasia, demyelinating diseases, unclear neurological conditions (including family history), pregnancy and breastfeeding, active HBV/Tbc infection.

Relative contraindications: systemic lupus erythematosus; for IFX: allergies to murine antibodies, pregnancy in the 1st and 2nd trimester. Paradoxical psoriasis: (class effect) switch to another class of biologics

Local reactions at the injection site, rarely angioedema, vertigo, headache, fever, fatigue, bacterial and viral infections, cytopenia, elevated liver enzymes, lupus-like syndrome, neurological symptoms incl. paraesthesia, multiple sclerosis, facial nerve palsy, lymphomas, solid organ tumours, squamous cell carcinomas, malignant melanomas, paradoxical psoriasis.

Yes, with simultaneous HBV therapy (start 3 months before anti-TNF therapy). HBV DNA and liver function every 2 months, in consultation with gastroenterology. Best evidence for etanercept.

Yes, monitoring of liver function and HCV RNA, therapy in consultation with gastroenterology. Best evidence for etanercept.

Possible; decision on a case-by-case basis, in consultation with infectious diseases.

Anakinra, Abatacept.

TB prophylaxis with isoniazid, rifampicin or isoniazid + rifampicin at least 1 month before starting therapy.

Slightly increased risk for skin carcinomas, but not for other tumours.