Biological DMARDs (bDMARDs) for rheumatoid arthritis

The various biological DMARDs (bDMARDs) are equally effective, and drug choice is influenced by patient preference regarding route of administration and dosing frequency. It is a PBS requirement that at least 2 csDMARDs must be trialled prior to assessing the need for a bDMARD. If indicated for the management of RA, the usual dosages for bDMARDs (listed in alphabetical order) are:

abatacept 500 to 1000 mg intravenously, as a single dose; repeat fortnightly for 2 further doses, then repeat every 4 weeks thereafter1Maxwell, 2009 abatacept abatacept abatacept

OR

abatacept 125 mg subcutaneously, once weekly1Maxwell, 2009 abatacept abatacept abatacept

OR

adalimumab 40 mg subcutaneously, every 2 weeksNavarro-Sarabia, 2006 adalimumab adalimumab adalimumab

OR

certolizumab pegol 400 mg subcutaneously, as a single dose; repeat fortnightly for 2 further doses; followed by 200 mg subcutaneously every 2 weeks thereafterRuiz Garcia, 2017 certolizumab pegol certolizumab pegol certolizumab pegol

OR

certolizumab pegol 400 mg subcutaneously, as a single dose; repeat fortnightly for 2 further doses, then repeat every 4 weeks thereafterRuiz Garcia, 2017 certolizumab pegol certolizumab pegol certolizumab pegol

OR

etanercept 50 mg subcutaneously, once weeklyLethaby, 2013 etanercept etanercept etanercept

OR

golimumab 50 mg subcutaneously, every 4 weeks1Singh, 2010 golimumab golimumab golimumab

OR

infliximab 3 mg/kg intravenously, as a single dose; repeat at 2 weeks and 6 weeks after the initial dose, then repeat every 8 weeks thereafter1Blumenauer, 2002 infliximab infliximab infliximab

OR

tocilizumab 162 mg subcutaneously, weeklySingh, 2011 tocilizumab tocilizumab tocilizumab

OR

tocilizumab 8 mg/kg intravenously, every 4 weeksSingh, 2011. tocilizumab tocilizumab tocilizumab

If the response to an initial bDMARD is insufficient to induce clinical remission or low disease activity, an alternative bDMARD may be trialled. Advice about switching DMARDs, for patients who have not responded to a tumour necrosis factor inhibitor (TNFi), is available from An Australian Living Guideline for the Pharmacological Management of Inflammatory Arthritis: Choice of DMARD in people with RA who have not responded to a TNFi2.

Rituximab is a specific bDMARD (B-cell antigen CD20 inhibitor) that is reserved for use in patients with severe active RA when a TNFi3Lopez-Olivo, 2015 has failed. If indicated for severe active drug-resistant RA, use:

rituximab 1 g intravenously, as a single dose; repeat dose once after 2 weeks. rituximab rituximab rituximab

If patients respond to the initial 2 doses of rituximab, treatment may be repeated (usually after 6 to 12 months) depending on disease activity. For more detail on considerations for use of bDMARDs, see Specific considerations for use of biological or targeted-synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
1 The Pharmaceutical Benefits scheme (PBS) states methotrexate must be coprescribed when abatacept or golimumab or infliximab are prescribed.Return
2 Australia & New Zealand Musculoskeletal Clinical Trials Network (ANZMUSC). Choice of DMARD in people with rheumatoid arthritis who have not responded to TNFi. An Australian Living Guideline for the Pharmacological Management of Inflammatory Arthritis. 2022 [version 2.8]. Accessed March 2023. Available from: https://app.magicapp.org/#/guideline/6936/section/121612Return
3 Tumour necrosis factor inhibitors (TNFi) include adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab.Return