Two Phase 3 Trials of Baricitinib for Alopecia Areata

N Engl J Med. 2022. Epub ahead of print doi: 10.1056/NEJMoa2110343

Phase 3 trials in patients with severe alopecia areata show that baricitinib is superior to placebo with respect to hair regrowth at 36 weeks.
Alopecia areata is characterised by nonscarring hair loss that can affect any hair-bearing site. Although mild cases of this emotionally- and psychosocially-distressing autoimmune disease may resolve within 12 months, more severe forms of the disease are unlikely to remit without treatment.

This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.

Merola and colleagues demonstrated a rapid and sustained reduction in hsCRP and the neutrophil-lymphocyte ratio (NLR) in patients with IMIDs with a high systemic inflammatory burden treated with secukinumab.

The authors reviewed drug survival of therapies across common inflammatory skin and joint conditions from national registries.  The findings highlighted that despite the overlapping pathogenesis of these conditions there was little similarity in drug survival. This reinforces the need for an individualised treatment approach consistent with the underlying disease, patient profile and treatment history.

Treatment of axial spondyloarthritis: an update

Nat Rev Rheumatol. 18, 205–216 (2022) 2022 doi: 10.1038/s41584-022-00761-z

In this review Danve and Deodhar report an update on modern axSpa treatment. They found that in the past two decades substantial progress in the diagnosis and management of axSpA has been witnessed. Whilst ASAS classification criteria have enabled earlier diagnosis the increased availability of novel therapies, evolving drug safety data and novel clinical trials have allowed clinicians to rethink the placement and timing of drugs in disease management.

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Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA

The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections.

Interleukin (IL)-17 inhibitors are a series of biological drugs used to treat a number of conditions, including ankylosing spondylitis, a disease characterised by immune system dysregulation and joint inflammation. Azadeh, et al. aimed to assess the risk of immune system-related AEs due to targeting IL-17 or IL-17R.

April 2022

Post hoc analysis of the RA-BEGIN trial finds that, over a one-year period, patients treated with baricitinib (monotherapy or in combination with methotrexate [MTX]) report greater pain relief and a more rapid attainment of clinically meaningful thresholds of pain improvement, than patients who receive MTX monotherapy.Often overlooked, when treating RA solely to a disease activity target, patient-reported pain is common in RA, even in those reaching inflammatory remission. The fact that pain per...

Oral surveillance and JAK inhibitor safety: the theory of relativity

Nat Rev Rheumatol. 2022. Epub ahead of print doi: 10.1038/s41584-022-00767-7

Putting the data into context, Winthrop, et al. conclude that the ORAL Surveillance data are not dissimilar to those from the original developmental programme, which suggested additional safety concerns at the 10 mg dosage and that resulted in the 5 mg twice daily dosage as the approved dose for RA.Following the recent results of the ORAL Surveillance (ORALSURV) study, and the consequent changes to the utilisation of JAKinibs, made by the regulatory authorities, Winthrop, et al. aim to put the O...
Vaccine sub-study of the BALANCE-EXTEND upadacitinib trial finds that approximately two-thirds of patients receiving upadacitinib 15 mg once-daily achieve a satisfactory humoral response to pneumococcal 13-valent conjugate (PCV-13) vaccine, despite receiving concomitant methotrexate (MTX).It is well known that a weakened immune response, comorbidities and immunosuppressant drug therapy all contribute to an increased susceptibility to infections in patients with RA. Likewise, the morbidity and mo...