From the Guidelines
For patients with axial spondyloarthritis, adalimumab is generally recommended as a first-line biologic treatment due to its established efficacy and safety profile, as supported by the 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations 1. Adalimumab, a tumor necrosis factor-alpha (TNF-alpha) inhibitor, is typically administered at a dose of 40 mg subcutaneously every other week.
Comparison with Tofacitinib
Tofacitinib, a Janus kinase (JAK) inhibitor, may be considered for patients who have failed or are intolerant to TNF-alpha inhibitors, such as adalimumab, as conditionally recommended by the guidelines 1. The recommended dose of tofacitinib for axial spondyloarthritis is 5 mg or 10 mg orally twice daily, but its use should be approached with caution due to potential increased risk of serious infections and other adverse events, as noted in the guidelines 1.
Key Considerations
- TNFi are preferred over tofacitinib as the first biologic to be used, according to the guidelines 1.
- Secukinumab or ixekizumab may be recommended over the use of a second TNFi in patients with primary non-response to the first TNFi, but tofacitinib is not the preferred choice in this scenario 1.
- Treatment duration and dosing should be individualized based on patient response and tolerability, with regular monitoring of disease activity, laboratory parameters, and potential side effects essential for both medications.
Decision-Making
In the absence of clear strong evidence supporting the use of tofacitinib as a first-line treatment, adalimumab remains the preferred choice for most patients with axial spondyloarthritis, as supported by the guidelines 1. However, the decision between adalimumab and tofacitinib should be made on a case-by-case basis, taking into account the individual patient's medical history, disease severity, and potential contraindications, as emphasized in the guidelines 1.
From the Research
Adalimumab (Humira) in the Treatment of 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.
- The clinical efficacy of adalimumab in adult patients meeting the Assessment of SpondyloArthritis international Society (ASAS) criteria for axSpA but not the modified New York criteria for ankylosing spondylitis (AS) has been demonstrated in the pivotal phase III, randomized, double-blind, placebo-controlled ABILITY-1 trial 2.
- Adalimumab was effective in improving the signs and symptoms of non-radiographic axSpA in patients who had active disease despite treatment with NSAIDs or who were intolerant to, or had a contraindication for, NSAIDs 2, 3.
- Efficacy of adalimumab was sustained over the longer term, according to data at 68 weeks from an open-label extension of ABILITY-1 2 and up to 3 years in the ABILITY-1 trial 4.
Comparison with Tofacitinib (Xeljanz)
- There are no direct comparisons between Adalimumab and Tofacitinib in the provided studies.
- However, it is mentioned that treatment with biologicals, including TNF inhibitors like adalimumab, is recommended for patients with persisting high disease activity despite continuous standard treatment with NSAIDs 5.
- Tofacitinib, a Janus kinase inhibitor, is not mentioned in the provided studies as a treatment option for axial spondyloarthritis.
Long-term Efficacy and Safety
- Adalimumab therapy provided sustained clinical and functional improvements through 3 years, as well as suppression of MRI axial inflammation, which was greater in patients who achieved clinical remission 4.
- The safety profile of adalimumab was consistent with prior studies, with no new safety concerns observed 4.
- Long-term safety and efficacy of adalimumab in the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis have been summarized, with adalimumab being clinically effective and reasonably safe in the short-term and long-term treatment of patients with AS who do not respond to standard therapy 6.