News in brief: Sleep problems common in AS; Tocilizumab gets official TGA approval for COVID-19 treatment; Dual biologics approach for recalcitrant PsA

2 Dec 2021

Sleep problems common in AS

Good ankylosing spondylitis (AS) control may be key to improving patients’ sleep and quality of life beyond traditional disease activity measures, Australian rheumatologists suggest.

A study of 495 AS patients who completed at least one sleep questionnaire between January 2019 and September 2020 found one third had self-reported apnoea and a fifth had moderate-to-severe insomnia.

Sleep problems were more severe in patients with poor versus good disease control (Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4, odds ratio: 7.29, 95% CI: 2.37–22.46, P = 0.001) and could lead to increased pain, fatigue, disease activity, mood and depressive symptoms, Canberra Rheumatology rheumatologist Dr Kathleen Tymms and her team wrote in Clinical Rheumatology.

“Screening for insomnia, sleep apnoea and fatigue in routine clinical care may provide a more holistic view of the burden of this disease, and striving to reach low disease activity may have greater positive impacts on patient quality of life beyond traditional clinical disease activity measures,” they suggested.


Tocilizumab gets official TGA approval for COVID-19 treatment

After being used off-label for several months as a treatment for severe COVID-19, tocilizumab (Actemra) has now received provisional approval from the Therapeutic Goods Administration (TGA).

The IL-6 inhibitor has been included in the Australian Register of Therapeutic Goods (ARTG) for the intravenous treatment of confirmed COVID-19 in hospitalised adults aged 18 years and older who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

“The TGA’s decision has been made on the basis of short-term efficacy and safety data. Continued approval of this indication depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment,” the regulator said.

Demand for tocilizumab products for use in COVID-19 has resulted in a global shortage since July 2021 that has denied the drug to patients with existing TGA approved indications such as arthritis and other inflammatory conditions.

The TGA says it has been working closely with manufacturer Roche and stakeholders including the Australian Rheumatology Association, to manage the shortages of tocilizumab, and supply is expected to stabilise in early 2022.


Dual biologics approach for recalcitrant PsA

Dual biologic therapy may be an effective option for patients with recalcitrant psoriatic arthritis that is not controlled by biologic monotherapy or other agents, Sydney clinicians say.

A novel combination of an IL-23 inhibitor (risankizumab) with a TNF-inhibitor (golimumab) was successful in the treatment of a 49-year old man with severe chronic plaque psoriasis and severe psoriatic arthritis that had not improved after almost two years of secukinumab followed by golimumab, according to a case report by dermatologists published in the Australasian Journal of Dermatology.

After six months of adding risankizumab the man showed significant improvement in both his cutaneous disease and his psoriatic and was able to resume his activities of daily living without adverse effects to date, the authors said. However they cautioned that little is known about the long-term efficacy and safety of combination biologics with dual targets, and it is essential to obtain informed consent from the patient and employ multidisciplinary care including input from a rheumatologists.

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