A question about whether or not currently licensed DMTs are effective in African-Americans has arisen. Why?
Lack of evidence does not mean lack of efficacy.
If you are a non-Caucasian pwMS you will become disabled quicker than your Caucasian counterparts. The evidence that so-called ‘non-whites’, which includes African-Americans, Africans and Asian do worse than ‘whites’ is pretty well accepted. However, most of this data was derived from the pre-DMT and 1st-generation, or injectable (IFNbeta and GA), DMT eras. The question of whether or not the same now holds true in the post-Natalizumab era is unclear.
Jagannadha Avasarala suggests in an editorial below that we should question the assumption that licensed DMTs work in these populations because we don’t have the necessary data to support our assumptions. Why? Simply, because there are too few African-Americans, Africans and Asians in the pivotal phase 3 trials to do sub-group analyses and answer the question he has proposed (see OPERA I & II data below).
These issues also apply to paediatric or childhood MS. In response to the latter, the FDA and EMA now mandate as part of the licensing process that Pharma have to do paediatric trials as part of their post-marketing commitments. Should the regulators be doing the same for the ethnic minority groups? Maybe, but this would come at a cost. Post-marketing commitments are expensive and their costs are built into the drug pricing. Do we want more expensive DMTs? A better solution would be to rely on real-world evidence collected in a systematic way via national and regional registers. I have little doubt that registry data will be able to tell us if ‘non-white’ pwMS respond or not to DMTs.
This editorial will not change our practice. We treat people with active MS who are from ethnic minorities in the same way we treat Caucasian pwMS. Why wouldn’t we? Lack of evidence does not mean lack of efficacy. In my experience pwMS who are from an ethnic minority background respond as well to high efficacy DMTs in terms of treating-2-target of NEDA than Caucasian pwMS. What tends to happen is that they are more likely to end up at the top of the treatment pyramid on one of the monoclonals. The reason for this is that they probably need these higher efficacy DMTs because they have more active MS. Should we rely on anecdotes? Probably not, I suggest we and others audit our data and get back to you on this specific question.
Pharmacotherapy of multiple sclerosis (MS) is evolving rapidly. Despite impressive gains over the past 2 decades in the approval of multiple drugs for MS, lack of recruitment of minorities with MS in phase 3 clinical studies is a persistent concern and skews efficacy and disability data.