Health News Review

This story about research on an experimental approach for lupus skin conditions raises more questions than answers regarding effectiveness.

Our Review Summary

A drug related to thalidomide (which is commonly used to treat lupus skin conditions), showed positive effects in a very small trial. But it may be too soon to start touting the benefits of the treatment without a more comprehensive clinical trial.  The story seemed more interested in highlighting thalidomide’s past than in explaining the very limited evidence for a new drug – the use of which may also be very limited.


Why This Matters

Lupus is an autoimmune condition (meaning your body develops antibodies that attacks itself) that can affect major organs including the heart, kidney, joints and brain. A more limited form, discoid lupus, only affects the skin. Systemic lupus can be a serious, life-threatening condition. Discoid lupus without the systemic manifestations is not but can be disfiguring. Fortunately both conditions are rare. Standard treatments for lupus are available and are effective for many. This study addresses those individuals who don’t improve with standard treatment.

While the reported benefit of lenalidomide in this study appears impressive, several important caveats should lead patients who may consider such a treatment to pause. First, the study included no comparison group. It is unclear how these patients may have responded to other medicines. Second, it isn’t clear whether these patients would do better with lenalidomide than with thalidomide in terms of effectiveness or side effects. Finally, the potential side effects of lenalidomide with longer term use (as mentioned things get worse when you stop it) is unclear. This is not a benign medicine and when used for a condition which, though disfiguring, isn’t life-threatening. It suggests that real caution should be taken before desperate patients start using lenalidomide before enough is known about its potential benefits and risks.


Criteria

Satisfactory

Does the story adequately discuss the costs of the intervention?

Satisfactory

Brief discussion of costs at the end of the story; however, costs were mentioned in relation to conditions for which lenalidomide is currently approved to treat (and the costs were taken from the manufacturer’s website).  If patients use lenalidomide for treatment of lupus skin conditions, which at the moment is off-label use, the patient could be responsible for total cost.

Not Satisfactory

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story was vague on the increased benefits seen with lenalidomide stating “All the other patients showed improvement, and the rash cleared up in 86%.” What does “showed improvement” mean? The story could have been more explicit that this was an uncontrolled, very small trial and it is possible that those selected may have been more likely to respond or tolerate the medicine than other patients with this condition.

Satisfactory

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

Although not found in the current study (probably due to small sample size and short follow-up period), lenalidomide may lead to progression of full-blown lupus – and the story appropriately mentioned this. Birth defects were also mentioned as possible side effects of using lenalidomide.

Not Satisfactory

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The study described in the story was not a randomized clinical trial and almost all of the patients (14 out of 15) had been treated with thalidomide before being treated with lenalidomide.  The study design does not allow for conclusions stating the drug may be better in treating patients with lupus skin conditions than current treatments. It is not clear that the medicine was more effective or better tolerated than thalidomide – which is much cheaper.

Not Applicable

Does the story commit disease-mongering?

Not Applicable

The article did not commit disease mongering. But it actually didn’t provide enough background on lupus skin conditions to even be judged on this criterion.

It could have mentioned that this is an uncommon skin condition and that it is addressing the uncommon individual with this condition that doesn’t respond to standard medications. That would have driven home point that the medication in question would be used very rarely.

Satisfactory

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story did interview a doctor outside of the current study team who cautioned about the treatment with lenalidomide may not be safe and effective for patients.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

To be clear,  the study did not compare lenalidomide to anything. The story discusses alternatives outside of these study results.

Not Satisfactory

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story explains that ” Lenalidomide is available as Revlimid to treat people with multiple myeloma and myelodysplastic syndromes.”  But for the lupus skin conditions in question, it is unclear if some doctors were currently using it off-label.  We think the story should have discussed this.  Any of the doctors interviewed could have answered this.

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

The story did discuss how this seems to be a novel approach to treating lupus skin conditions.

Satisfactory

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story lists this news release as one of its sources.  However, there isn’t any clear evidence that the story relied solely or largely on it.

Total Score: 6 of 9 Satisfactory


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