Intravenous methylprednisolone as add-on induction therapy for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial.

What was studied

This randomised, double-blind trial tested added methylprednisolone in chronic inflammatory demyelinating polyradiculoneuropathy, or CIDP. The trial asked if methylprednisolone by vein, added to IVIg, raises remission rates. Adults could join if they had no past treatment. They could also join after a relapse. Others had needed more treatment after one IVIg dose. Methylprednisolone 1000 mg or placebo was given every 3 weeks for 18 weeks. All got IVIg. The loading dose was 2 g/kg. Maintenance doses were 1 g/kg. The main outcome was remission at 52 weeks, with no need for more treatment.

What they found

Enrolment was halted after 77 of 96 planned people joined. This was because of safety concerns. Thromboembolic events occurred in the IVIg plus methylprednisolone group. None occurred with placebo. 14 of 37 people in the methylprednisolone group were in remission at 52 weeks. 11 of 40 people in the placebo group were. The difference was not significant, with p=0.47. Some secondary outcomes showed more improvement in disability at 18 and 52 weeks with methylprednisolone.

What it means for patients

The authors say the study was stopped early because of safety concerns. They say clotting events occurred in the combined group. They say the combination gave no significant gain in remission over IVIg alone.

Why it is not certain yet

The trial stopped early, with fewer people than planned. The range around the difference was wide, from -11 to 31. The results apply to the doses used. The secondary outcomes were not the main outcome. The abstract does not give long-term safety results.

Source

Intravenous methylprednisolone as add-on induction therapy for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial.

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