<p>Tofidence is a medicine used to treat:</p><ul><li>adults with severe rheumatoid arthritis that is getting worse, who have not been previously treated with a medicine called methotrexate;</li><li>adults with moderate to severe active rheumatoid arthritis in whom previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well enough or were not tolerated;</li><li>children from 2 years of age with active systemic juvenile idiopathic arthritis in whom other treatments (anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;</li><li>children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.</li></ul><p>Tofidence is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.</p><p>Tofidence can also be used in adults with COVID-19 who are receiving treatment with corticosteroids by mouth or injection and require extra oxygen or mechanical ventilation (breathing assisted by a machine).</p><p>Tofidence contains the active substance tocilizumab and is a ‘biosimilar medicine’. This means that Tofidence is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Tofidence is RoActemra. For more information on biosimilar medicines, see <a href="https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines">here</a>.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Rheumatoid arthritis (RA):</p><ul><li>the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination with MTX).</li><li>the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX).</li></ul><p>Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.</p><p>Polyarticular juvenile idiopathic arthritis (pJIA): the treatment of juvenile idiopathic polyarthritis (PJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX (monotherapy or in combination with MTX).</p><p>Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).</p></div>
Therapeutic Area (MeSH)
ATC Code
L04AC07
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| tocilizumab | N/A | tocilizumab |
EMA Name
Tofidence
Medicine Name
Tofidence
Aliases
N/ANo risk management plan link.