Only a few years ago, Alice B. Gottlieb, MD, PhD, became Chair of Dermatology and Dermatologist-in-chief at Tufts Medical Center. In that time, however, she has put the Medical Center on the proverbial map when it comes to dermatological research.
“We’re not only as good as or better than any other Boston hospital, but also among the top centers for psoriasis and psoriatic arthritis research in the United States, with numerous clinical trials in this field alone currently underway,” she notes. These include investigator-initiated studies as well as participation in national multi-center pharmaceutical trials.
Similarly, in her role as Chair of the Department of Dermatology and the Harvey B. Ansell Professor of Dermatology at Tufts University School of Medicine, Gottlieb has spearheaded creation of a dermatology residency program and dermatopathlogy fellowship program that are attracting young investigators and faculty with research interests.
Gottlieb herself is renowned for her work focusing on psoriasis and psoriatic arthritis (PsA), chronic inflammatory diseases linked to dysfunctional immune activity. Psoriasis is characterized by an increase in skin cell generation that produces thickened, sometimes itchy or painful lesions covered with excess dead cells that present as white scales. PsA involves painful and often debilitating joint and connective tissue inflammation. Both psoriasis and psoriatic arthritis are associated with increased risk for metabolic syndrome – the cluster of medical disorders, including hypertension and high triglycerides that increase the risk of cardiovascular disease and diabetes, increased incidence of both myocardial infarction and premature death.
Board-certified in rheumatology and dermatology as well as internal medicine, Gottlieb is uniquely positioned to take advantage of advances in rheumatology and apply them to dermatology. The often-described “Jewish mother of biologics for psoriasis and psoriatic arthritis” has been directly involved in more than 100 clinical trials in this area.
One study is investigating whether children with moderate to severe psoriasis are at increased risk of metabolic syndrome compared to children with warts.
“We know that in adults, psoriasis is an independent risk factor for cardiovascular morbidity and mortality,” Gottlieb explains. “But what happens in children with psoriasis – are they at the same risk for atherosclerotic disease from early on?” She is looking at the various markers for metabolic syndrome as well as measuring flow-mediated dilatation of the brachial artery, which in adults, has been demonstrated to be a marker for atherosclerotic heart disease.
“This is a study in progress, so we’d appreciate referrals of any young patients with psoriasis,” she adds. “It doesn’t just benefit society but also the patient. We’ve detected high LDL and triglycerides in these children, so even though this is a non-interventional study, we’re able to advise follow-up with the child’s PCP so that something can be done sooner rather than later.”
Another investigational study is comparing the mechanism of action of adalimumab (HUMIRA®) to methotrexate – two already FDA-approved treatments – in adult patients with moderate to severe psoriasis.
“Despite the fact that methotrexate has been in use for decades, its mechanism of action in treating psoriasis and psoriatic arthritis is not understood, and it doesn’t work as well as the newer drug adalimumab,” Gottlieb says. “So we’re replicating the methodology of the active comparator study between the two, but looking at skin biopsies to get an answer as to why adalimumab works better.”
Gottlieb’s team also is completing a study to evaluate whether a phosphodiesterase inhibitor shown to work well for psoriasis might also be effective in treating eczema and contact dermatitis, conditions poorly addressed by existing treatment options.
Patient referrals to these and other studies are always welcomed and appreciated, and health insurance is not required for most of them. Gottlieb also wants to reassure referring physicians that their patients will be returned to them after a trial if that is the physician’s wish.
Gottlieb also has a special appreciation for study enrollees.
“All my patients are important, but study volunteers are giving of themselves,” she says. “That makes them exceptionally important.
“Clinical research does something good for the patient,” Gottlieb stresses. “And it can tell us more about what’s clinically relevant than anything else. Animal models simply can’t tell you as much as one good clinical trial about the pathogenesis of disease because they’re just not great in predictive qualities. For example, in multiple sclerosis research, it was predicted that TNF blockers [TNF is a cytokine that’s a key mediator of inflammation] would work, but in actual human trials they made the disease worse.
“Our clinical trials are making patients better, in novel ways not done before,” she adds. “And the patient’s best interests always come first.”