From the Guidelines
Adalimumab is recommended as the first-line biologic treatment for axial spondyloarthritis due to its established efficacy and safety profile. The typical dosing regimen for Adalimumab is 40 mg administered subcutaneously every other week 1. If a patient fails to respond to Adalimumab or experiences intolerable side effects, Tofacitinib could be considered as a second-line option, but its use should be approached with caution due to less extensive clinical experience compared to Adalimumab 1. Tofacitinib is typically dosed at 5 mg or 10 mg orally twice daily.
Key Considerations
- Patients should be closely monitored for signs of infection, liver enzyme elevations, and other potential side effects when initiating either of these medications 1.
- In patients who do not respond to biologic therapy, other treatment options such as NSAIDs, physical therapy, and lifestyle modifications should be optimized and considered 1.
- TNFi remains the primary class of medications for the treatment of AS and nonradiographic axial SpA, with secukinumab or ixekizumab recommended for patients with active disease who have heart failure or demyelinating disease as a contraindication to TNFi, and in primary non-responders to TNFi 1.
Treatment Recommendations
- Adalimumab is the preferred first-line biologic treatment due to its established efficacy and safety profile 1.
- Tofacitinib is a potential second-line option for patients with contraindications to TNFi other than infections 1.
- Patients with coexisting IBD or recurrent uveitis should be treated with TNFi monoclonal antibodies, as they are better options for these conditions 1.
From the Research
Comparison of Adalimumab and Tofacitinib in Axial Spondyloarthritis
- Adalimumab is a fully human, recombinant, monoclonal IgG1 antibody specific for the cytokine tumour necrosis factor-α, approved for the treatment of various inflammatory disorders, including severe non-radiographic axial spondyloarthritis (axSpA) 2.
- Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA) 3.
- A multicentric medical records review study compared the effectiveness and tolerability of tofacitinib with adalimumab in AxSpA, and found that mean improvement of BASDAI and ASDAS were comparable between the adalimumab and tofacitinib groups 3.
- However, a higher proportion of patients achieved BASDAI50 response in the adalimumab group, and a higher proportion of patients in the tofacitinib group required change in therapy 3.
- Adalimumab has been shown to be clinically effective and reasonably safe in the short-term and long-term treatment of patients with AS who do not respond to standard therapy 4.
- The efficacy of adalimumab in patients with non-radiographic axial spondyloarthritis has also been demonstrated, with a significant proportion of patients achieving an ASAS40 response 2, 5.
- A study on the efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis found that continued therapy was associated with significantly fewer patients flaring than was treatment withdrawal 6.
Efficacy and Safety
- Adalimumab has been shown to be effective in improving the signs and symptoms of non-radiographic axSpA, with a significant proportion of patients achieving an ASAS40 response 2, 5.
- Tofacitinib has been found to have comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months 3.
- Adalimumab has been generally well tolerated in clinical trials of non-radiographic axSpA, with an adverse event profile similar to that in patients with AS or other approved indications 2.
- The most common adverse events reported in patients receiving adalimumab were nasopharyngitis, upper respiratory tract infection, and worsening of axial spondyloarthritis 6.
Treatment Outcomes
- A higher proportion of patients achieved BASDAI50 response in the adalimumab group, and a higher proportion of patients in the tofacitinib group required change in therapy 3.
- Continued adalimumab therapy was associated with significantly fewer patients flaring than was treatment withdrawal in patients with non-radiographic axial spondyloarthritis who achieved sustained remission 6.
- The Incremental Cost-Effectiveness Ratio (ICER) for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4 3.