Promise with BTK inhibitor in Sjögren’s syndrome

The novel covalent BTK inhibitor remibrutinib appears to improve symptoms in moderate to severe Sjögren’s syndrome, a study has shown.

The phase 2a LOUiSSe study presented at ACR Convergence randomised 73 patients including Australians to receive oral remibrutinib 100 mg bid, 100 mg qd, or placebo over 24 weeks.

Professor Thomas Dörner, from the Charite University Hospitals Berlin, Germany, said the primary outcome of improvement in the EULAR Sjögren’s syndrome (SS) disease activity index (ESSDAI) at 24 weeks was observed with remibrutinib compared to placebo (p=0.003).

However there was no treatment effect on the EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) compared to placebo, including the subdomains of dryness, pain and fatigue.

Remibrutinib was associated with a trend towards improved unstimulated salivary flow. Other outcome measures included a demonstrable decrease in the cytokine CXCL13, IgM and IgG levels, and disease-related autoantibodies with remibrutinib.

Professor Dörner said adverse events were equally distributed between remibrutinib and placebo groups.

“The LOUiSSe study suggests that remibrutinib is a potentially effective oral disease-modifying therapy for Sjögren’s syndrome which will be established in longer term studies.”

He said remibrutinib had also been shown to have promising efficacy and safety in chronic spontaneous urticaria [link here].

The study was sponsored by Novartis.

No progression benefit from NSAID in ankylosing spondylitis

Combining an NSAID and TNF inhibitor does not significantly slow radiographic spinal progression in patients with radiographic axSpA and high disease activity.

Dr Fabian Proft, a rheumatologist and senior researcher at Charité Universitätsmedizin Berlin, presented the results of a prospective RCT which randomised 157 patients to golimumab plus celecoxib or golimumab alone.

Patients had at least one additional risk factor for radiographic progression such as an elevated C-reactive protein or existing syndesmophytes.

The study found the combination therapy did not show significant superiority over biologic monotherapy in retarding radiographic spinal progression in r-axSpA patients.

The modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change after two years was 1.1 with the combination therapy compared to 1.7 with the biologic alone (p=0.79).

“… based on our data, continuous treatment with NSAIDs in addition to a biologic DMARD solely to inhibit future radiographic progression cannot be generally recommended,” he said.

Reflux treatment improves survival in scleroderma 

Gastroesophageal reflux (GORD) affects almost all scleroderma patients and its treatment improves survival in all patients, including in those with ILD.

Speaking at ACR Convergence, Dr Allanah Quinlivan from St Vincent’s Hospital Melbourne, presented findings from 1,640 consecutive patients enrolled in the Australian Scleroderma Cohort Study.

The study found GORD in 93.8% of scleroderma patients and was significantly associated with more severe skin disease, the presence of joint contractures, digital ulcers and hospitalisations (all p< 0.001).

Reflux was not associated with the presence, severity or time to development of ILD.

As well, treatment of GORD did not delay the onset of ILD however the study found treatment significantly improved survival in all scleroderma patients, including those with ILD.

“More aggressive reflux combination therapy with both a histamine 2 receptor antagonist and proton pump inhibitor significantly improved survival over single agent therapy,” she said.