Positive Trial of Cannabinoids in Systemic Sclerosis!

There is evidence that cannabinoids inhibit fibrosis in scleroderma (systemic sclerosis, SSc) fibroblasts (Garcia-Gonzalez E, et al, Rheumatology 2009;48:1050-6), so it may not be a large leap to think that it could improve immune dysregulation or inhibit fibrosis in scleroderma patients. Spiera R, et al (#OP0126) presented a trial with intriguing results using Anabasum (also known as JBT-101), a synthetic, oral, non-immunosuppressive CB2 agonist that could theoretically reset the innate immune response in SSc.

Forty-two patients with diffuse SSc of up to 6 years’ duration were randomized 2:1 to Anabasum or placebo with an up-titrating dose. There were improvements on several measures of the composite response score (CRISS). The CRISS includes the modified Rodnan skin score (mRSS), patient and physican global assessments, HAQ and FVC% predicted. The drug was well tolerated although there was some dizziness and mild fatigue in the active treatment arm.

Also in support of a favorable drug effect for anabasum but not placebo, there was a shift in lipid mediator production, with an increase in pro-resolving vs. pro-inflammatory lipid mediators.

What I am a bit skeptical about is the improvement was demonstrated with only 84 days of treatment (<3 months). Improvement in pain (if this occurred frequently on active treatment) would potentially improve patients' function and global assessment, but this would not be considered disease modifying. However, more data are needed and this is an interesting chemical which needs further study in SSc.

It appears that this synthetic CB2 agonist will move into a Phase III drug trial. Who would have thought that this agent would have a positive trial?

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