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Pearl Toh, 26 Nov 2020
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Seletalisib shows therapeutic potential in primary Sjögren’s syndrome

19 Oct 2020

The selective PI3Kδ inhibitor seletalisib demonstrates clinical activity in patients with primary Sjögren’s syndrome (PSS) despite enrolment-related underpowering, as shown in phase II trial data.

In total, 27 patients with moderate-to-severe PSS were randomized to treatment with either seletalisib 45 mg/day (n=13; mean age, 52.2 years; 12 women) or placebo (n=14; mean age, 60.2 years; 13 women); 20 of them completed the study. The trial was terminated prematurely due to enrolment challenges with loss of statistical power (36 percent vs 80 percent planned).

At week 12, both arms showed a change in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score, but the reduction was greater with the study drug (difference, –2.59, 95 percent confidence interval [CI], –7.30 to 2.11; p=0.266). The change seen in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score was also greater with seletalisib (difference, –1.55, 95 percent CI, –3.39 to 0.28).

There were no significant changes in saliva and tear flow.

In terms of safety, serious adverse events (AEs) developed in 3/13 of patients on seletalisib vs 1/14 of those on placebo. AEs led to treatment discontinuation in five and one patients, respectively. The most common event was diarrhoea.

Serum IgM and IgG concentrations markedly dropped in the seletalisib arm. The study drug produced an improvement in size and organization of salivary gland inflammatory foci and in target engagement, which therefore reduced PI3K-mTOR signaling compared with placebo.

Larger studies with specific PI3Kδ inhibitors and, potentially, with patient stratification are needed.

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Most Read Articles
5 days ago
Among postmenopausal women, short sleep duration and depression contribute to increased fall accidents, as reported in a study.
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.