Autoinflammatory & rare systemic diseases

Thalidomide can effectively prevent relapse in IgG4-related disease outweighing its side effects: a multicentre, randomised, double-blinded, placebo-controlled study

Ann Rheum DisPublished Randomised controlled trial

Authors' conclusion

Thalidomide can effectively prevent relapse in IgG4-RD outweighing its side effects

Study context

Population
Patients with active IgG4-related disease (IgG4-RD)57 finished per protocol
Participants
60 patients
Comparison
Glucocorticoids (GCs)+Thalidomide vs GCs+Placebo
  • GCs+Thalidomiden = 29
  • GCs+Placebon = 28reference
Primary endpoint
Disease relapse rate
Follow-up
Month 12
Methodological detailsmulticentre, double-blinded, placebo-controlled, 1:1 randomisation
  • Multicentre
  • Double-blinded
  • Placebo-controlled
  • 1:1 randomisation

Primary result

As reported in the abstract

Relapse rate
NNT for thalidomide (relapse)
2

Secondary outcomes

Remission rate · month 12

Response rate

Safety

Adverse events (AEs) (all participants) · 12-month follow-up

Total AEs
49
Participants with AEs
35
Moderate AEs
4
Mild AEs
45
NNH for thalidomide (moderate AEs)
8

Original publication

Thalidomide can effectively prevent relapse in IgG4-related disease outweighing its side effects: a multicentre, randomised, double-blinded, placebo-controlled study. Ann Rheum Dis. Published 16 February 2025. doi:10.1016/j.ard.2025.01.033

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