TBD Meeting (3103-19)

MILAN – A checkpoint inhibitor given with or without targeted therapy resulted in robust response rates in patients with advanced basal cell carcinoma, according to an investigator in a recent proof-of-concept study.

The side effect profile for the progressive death 1 (PD-1) inhibitor pembrolizumab (Keytruda), plus or minus the hedgehog pathway inhibitor vismodegib (Erivedge), was “not out of range” with what’s been observed in other cancer types, said Anne Lynn S. Chang, MD, a medical dermatologist at Stanford (Calif.) University.

Taken together, these safety and efficacy results suggest pembrolizumab could prove useful for patients with advanced basal cell carcinomas, Dr. Chang said in an oral presentation at the World Congress of Dermatology.

Unexpectedly, dual therapy with pembrolizumab and vismodegib was not clearly superior to pembrolizumab alone, though the two arms are not directly comparable in this nonrandomized, investigator-initiated study, according to Dr. Chang.

“That was a surprise for us, but this is a subjective and a small study,” she told attendees at the conference.

There is currently a multi-institutional clinical trial underway to evaluate another PD-1 inhibitor, cemiplimab, in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor, she said.

While a large fraction of basal cell carcinomas are cured by resection, those that are locally advanced or metastatic to lymph nodes or distant organs are challenging to manage. Hedgehog pathway inhibitors, which include vismodegib and sonidegib, are the only Food and Drug Administration–approved drug class in this setting, but more than half of patients do not have a response to treatment, and another 20% or so will initially respond but develop resistance, Dr. Chang said.

Other treatments that have been tried in advanced basal cell carcinomas include taxanes, platinum-based agents, 5-fluorouracil, and everolimus, but their efficacy is unclear, according to Dr. Chang, because of a lack of systematic studies.

Investigators thought PD-1 inhibitors might be promising in basal cell carcinoma for a few reasons, Dr. Chang said. In particular, PD-1 inhibitor treatment response has been linked to mutational burden and PD–ligand 1 expression, and advanced basal cell carcinomas have the largest mutational burden of all human cancers, a large proportion of which express PD-L1.

There are multiple case reports in the literature suggesting that advanced basal cell carcinoma is responsive to PD-1 inhibitors, she added.

In the study, nine patients received 200 mg infusion of pembrolizumab every 3 weeks, and seven received the pembrolizumab infusions plus oral vismodegib 150 mg per day.

The pembrolizumab monotherapy group included patients who had tumor progression on vismodegib, did not tolerate vismodegib, or had contraindications to vismodegib. The pembrolizumab-vismodegib regimen was used in patients who had prior stable or partial responses to hedgehog pathway inhibitors.

The overall response rate was 38%, or 6 of 16 patients, with a 70% probability of 1-year progression-free survival and 94% probability of 1-year overall survival, Dr. Chang reported.

The results did not make the case that pembrolizumab and vismodegib was superior to pembrolizumab alone, though as Dr. Chang noted, the numbers of patients were small. Response rates were 29% (two of seven patients) in the combination arm and 44% (four of nine patients) in the monotherapy arm.

There were 24 immune-related adverse events in the trial; the most serious was hyponatremia, which was reversible, according to Dr. Chang. The overall rates of grade 3-4 adverse events were 22% for pembrolizumab monotherapy and 17% for dual therapy.

A report on the study has also been published in the Journal of the American Academy of Dermatology.

Funding for the study was provided by Merck. Dr. Chang reported serving as a clinical investigator and advisory board member for studies sponsored by Genentech-Roche, Merck, Novartis, and Regeneron.
 

MILAN – A checkpoint inhibitor given with or without targeted therapy resulted in robust response rates in patients with advanced basal cell carcinoma, according to an investigator in a recent proof-of-concept study.

The side effect profile for the progressive death 1 (PD-1) inhibitor pembrolizumab (Keytruda), plus or minus the hedgehog pathway inhibitor vismodegib (Erivedge), was “not out of range” with what’s been observed in other cancer types, said Anne Lynn S. Chang, MD, a medical dermatologist at Stanford (Calif.) University.

Taken together, these safety and efficacy results suggest pembrolizumab could prove useful for patients with advanced basal cell carcinomas, Dr. Chang said in an oral presentation at the World Congress of Dermatology.

Unexpectedly, dual therapy with pembrolizumab and vismodegib was not clearly superior to pembrolizumab alone, though the two arms are not directly comparable in this nonrandomized, investigator-initiated study, according to Dr. Chang.

“That was a surprise for us, but this is a subjective and a small study,” she told attendees at the conference.

There is currently a multi-institutional clinical trial underway to evaluate another PD-1 inhibitor, cemiplimab, in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor, she said.

While a large fraction of basal cell carcinomas are cured by resection, those that are locally advanced or metastatic to lymph nodes or distant organs are challenging to manage. Hedgehog pathway inhibitors, which include vismodegib and sonidegib, are the only Food and Drug Administration–approved drug class in this setting, but more than half of patients do not have a response to treatment, and another 20% or so will initially respond but develop resistance, Dr. Chang said.

Other treatments that have been tried in advanced basal cell carcinomas include taxanes, platinum-based agents, 5-fluorouracil, and everolimus, but their efficacy is unclear, according to Dr. Chang, because of a lack of systematic studies.

Investigators thought PD-1 inhibitors might be promising in basal cell carcinoma for a few reasons, Dr. Chang said. In particular, PD-1 inhibitor treatment response has been linked to mutational burden and PD–ligand 1 expression, and advanced basal cell carcinomas have the largest mutational burden of all human cancers, a large proportion of which express PD-L1.

There are multiple case reports in the literature suggesting that advanced basal cell carcinoma is responsive to PD-1 inhibitors, she added.

In the study, nine patients received 200 mg infusion of pembrolizumab every 3 weeks, and seven received the pembrolizumab infusions plus oral vismodegib 150 mg per day.

The pembrolizumab monotherapy group included patients who had tumor progression on vismodegib, did not tolerate vismodegib, or had contraindications to vismodegib. The pembrolizumab-vismodegib regimen was used in patients who had prior stable or partial responses to hedgehog pathway inhibitors.

The overall response rate was 38%, or 6 of 16 patients, with a 70% probability of 1-year progression-free survival and 94% probability of 1-year overall survival, Dr. Chang reported.

The results did not make the case that pembrolizumab and vismodegib was superior to pembrolizumab alone, though as Dr. Chang noted, the numbers of patients were small. Response rates were 29% (two of seven patients) in the combination arm and 44% (four of nine patients) in the monotherapy arm.

There were 24 immune-related adverse events in the trial; the most serious was hyponatremia, which was reversible, according to Dr. Chang. The overall rates of grade 3-4 adverse events were 22% for pembrolizumab monotherapy and 17% for dual therapy.

A report on the study has also been published in the Journal of the American Academy of Dermatology.

Funding for the study was provided by Merck. Dr. Chang reported serving as a clinical investigator and advisory board member for studies sponsored by Genentech-Roche, Merck, Novartis, and Regeneron.
 

MILAN – A checkpoint inhibitor given with or without targeted therapy resulted in robust response rates in patients with advanced basal cell carcinoma, according to an investigator in a recent proof-of-concept study.

The side effect profile for the progressive death 1 (PD-1) inhibitor pembrolizumab (Keytruda), plus or minus the hedgehog pathway inhibitor vismodegib (Erivedge), was “not out of range” with what’s been observed in other cancer types, said Anne Lynn S. Chang, MD, a medical dermatologist at Stanford (Calif.) University.

Taken together, these safety and efficacy results suggest pembrolizumab could prove useful for patients with advanced basal cell carcinomas, Dr. Chang said in an oral presentation at the World Congress of Dermatology.

Unexpectedly, dual therapy with pembrolizumab and vismodegib was not clearly superior to pembrolizumab alone, though the two arms are not directly comparable in this nonrandomized, investigator-initiated study, according to Dr. Chang.

“That was a surprise for us, but this is a subjective and a small study,” she told attendees at the conference.

There is currently a multi-institutional clinical trial underway to evaluate another PD-1 inhibitor, cemiplimab, in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor, she said.

While a large fraction of basal cell carcinomas are cured by resection, those that are locally advanced or metastatic to lymph nodes or distant organs are challenging to manage. Hedgehog pathway inhibitors, which include vismodegib and sonidegib, are the only Food and Drug Administration–approved drug class in this setting, but more than half of patients do not have a response to treatment, and another 20% or so will initially respond but develop resistance, Dr. Chang said.

Other treatments that have been tried in advanced basal cell carcinomas include taxanes, platinum-based agents, 5-fluorouracil, and everolimus, but their efficacy is unclear, according to Dr. Chang, because of a lack of systematic studies.

Investigators thought PD-1 inhibitors might be promising in basal cell carcinoma for a few reasons, Dr. Chang said. In particular, PD-1 inhibitor treatment response has been linked to mutational burden and PD–ligand 1 expression, and advanced basal cell carcinomas have the largest mutational burden of all human cancers, a large proportion of which express PD-L1.

There are multiple case reports in the literature suggesting that advanced basal cell carcinoma is responsive to PD-1 inhibitors, she added.

In the study, nine patients received 200 mg infusion of pembrolizumab every 3 weeks, and seven received the pembrolizumab infusions plus oral vismodegib 150 mg per day.

The pembrolizumab monotherapy group included patients who had tumor progression on vismodegib, did not tolerate vismodegib, or had contraindications to vismodegib. The pembrolizumab-vismodegib regimen was used in patients who had prior stable or partial responses to hedgehog pathway inhibitors.

The overall response rate was 38%, or 6 of 16 patients, with a 70% probability of 1-year progression-free survival and 94% probability of 1-year overall survival, Dr. Chang reported.

The results did not make the case that pembrolizumab and vismodegib was superior to pembrolizumab alone, though as Dr. Chang noted, the numbers of patients were small. Response rates were 29% (two of seven patients) in the combination arm and 44% (four of nine patients) in the monotherapy arm.

There were 24 immune-related adverse events in the trial; the most serious was hyponatremia, which was reversible, according to Dr. Chang. The overall rates of grade 3-4 adverse events were 22% for pembrolizumab monotherapy and 17% for dual therapy.

A report on the study has also been published in the Journal of the American Academy of Dermatology.

Funding for the study was provided by Merck. Dr. Chang reported serving as a clinical investigator and advisory board member for studies sponsored by Genentech-Roche, Merck, Novartis, and Regeneron.
 

MILAN – In a region where scabies is endemic, a strategy of mass drug treatment for scabies resulted in durable reduction of both scabies and impetigo, findings that may have implications for future treatment of scabies or other infestations in other regions, dermatologist Margot Whitfield, MD, said at the World Congress of Dermatology.

“Mass drug administration is highly effective and safe in the treatment of endemic scabies,” she said.

Using a strategy of directly observed treatment (DOT) with oral ivermectin or topical permethrin for all residents of two separate island groups in Fiji, Dr. Whitfield, together with epidemiologist Lucia Romani, PhD, both of the University of New South Wales, Sydney, and coinvestigators, demonstrated large and sustained decreases in the rates of scabies and impetigo (N Engl J Med. 2015 Dec 10;373[24]:2305-13).

Across study arms, which included a usual care arm, the baseline rate for scabies ranged from 30% to 40%. With usual care, the rate dropped from 36.6% to 18.8% at the end of 12 months, a relative reduction of 49%. However, the 15.8% prevalence rate 12 months after permethrin DOT (from 41.7%), and the 1.9% rate 12 months after ivermectin DOT (from 32.1%) – reductions of 62% and 94%, respectively – represented much larger decreases, “especially since these reductions were seen without any further interventions,” Dr. Whitfield said. “This was extremely exciting, and a game-changer as far as the management of endemic scabies is concerned.”

At baseline, impetigo rates hovered around 20%-25%, and usual care resulted in a 32% reduction at 12 months. With permethrin DOT, the impetigo rate dropped by 54%; with ivermectin DOT, the impetigo rate dropped by 67%. “The community level of impetigo went down, purely as a result of treating the scabies,” Dr. Whitfield said.

The outcomes of this study, she noted, “have contributed to the global discussion of the treatment of scabies.”

Two years after the mass drug administration (MDA) campaign, scabies prevalence remained much lower than at baseline, with clinical scabies diagnosed in 15.2% of the usual care group, 13.5% of the permethrin group, and just 3.6% of the ivermectin group. “The exciting thing for us was that these levels ... were able to be sustained at 2 years,” Dr. Whitfield noted.

The islands that had received ivermectin saw a continued decline in impetigo prevalence as well: By 24 months, impetigo was seen in 2.6% of participants in that arm.


Scabies is a neglected – but highly treatable – tropical disease, she noted. It is associated with intense pruritus, which results in reduced quality of life, and excoriations predispose those affected to bacterial superinfections, commonly impetigo in the young.

In Fiji, the scabies mite infests nearly 40% of those aged 5-9 years, and over one-third of those younger than 5 years. Rates drop steeply with increasing age and then climb again for the elderly; still, prevalence tops 10% for all Fijian age groups, Dr. Whitfield pointed out. Overall, scabies prevalence is 23% in Fiji, with resultant impetigo affecting 19% of the population.

Providing more details about the study, she said that she and her collaborators – working in conjunction with the Fijian Ministry of Health – took advantage of the geography of the island country, whose 850,000 residents live on 300 islands, to compare mass drug treatment with either ivermectin or permethrin with usual care. “We actually didn’t look for ‘infected scabies,’ ” she explained. “We looked for scabies as one outcome, and infection as another.”

The study was designed to take advantage of lessons from previous public health work addressing filariasis and soil-transmitted helminths, and addressed the following question: In Fiji, could a single round of MDA for scabies control lead to sustained reductions in scabies and impetigo prevalence 12 months later, compared with standard care?

For one MDA arm, island residents received oral ivermectin via DOT. A second DOT dose was administered for those with clinically diagnosed scabies. For pregnant and breastfeeding women, children weighing less than 15 kg, and those with ivermectin hypersensitivity, permethrin was used, Dr. Whitfield said.

The individuals in the permethrin MDA arm received one topical dose via DOT, with a second round of topical permethrin for those with topical scabies.

In all, 803 Fijians were assigned to receive standard of care, 532 permethrin MDA, and 716 ivermectin MDA. Of these, 623 received ivermectin DOT, and 93 received permethrin. In all, DOT was achieved for 96% of those receiving the first dose. At baseline, 230 patients had scabies, with 200 receiving ivermectin and 30 permethrin; the DOT rate was 100% for the second dose.

For the permethrin arm, just 307 of 532 participants (58%) had DOT, though all were given permethrin. Scabies was present at baseline for 222 participants, and of these, 181 had DOT. “It’s much easier to do the direct observed therapy with an oral medication than with a cream,” Dr. Whitfield said. Data were not collected for the Fijians who received usual care at community health centers.

Outcomes were clinically determined via the child skin assessment algorithm of the World Health Organization’s International Management of Childhood Illness (IMCI) guidelines.

Dr. Whitfield acknowledged that the study was not a true cluster-randomized trial, and differences existed between the communities studies. Also, “dermatoscopy was not a practical option” for this real-world trial in a resource-limited setting, but validated clinical criteria were used, she said.

Going forward, she and her colleagues are continuing to track durability of reduced scabies rates, as well as downstream sequelae such as impetigo and septicemia. Also, “we need to see whether this community- and island-based project could be scaled up to a national or regional level,” she said.

The burden of disease from scabies globally is probably underestimated, and changing migration patterns may bring endemic scabies to the doorsteps of more developed nations, prompting consideration of MDA as a strategy in expanded circumstances.

Dr. Whitfield reported that she had no relevant conflicts of interest.

[email protected]

MILAN – In a region where scabies is endemic, a strategy of mass drug treatment for scabies resulted in durable reduction of both scabies and impetigo, findings that may have implications for future treatment of scabies or other infestations in other regions, dermatologist Margot Whitfield, MD, said at the World Congress of Dermatology.

“Mass drug administration is highly effective and safe in the treatment of endemic scabies,” she said.

Using a strategy of directly observed treatment (DOT) with oral ivermectin or topical permethrin for all residents of two separate island groups in Fiji, Dr. Whitfield, together with epidemiologist Lucia Romani, PhD, both of the University of New South Wales, Sydney, and coinvestigators, demonstrated large and sustained decreases in the rates of scabies and impetigo (N Engl J Med. 2015 Dec 10;373[24]:2305-13).

Across study arms, which included a usual care arm, the baseline rate for scabies ranged from 30% to 40%. With usual care, the rate dropped from 36.6% to 18.8% at the end of 12 months, a relative reduction of 49%. However, the 15.8% prevalence rate 12 months after permethrin DOT (from 41.7%), and the 1.9% rate 12 months after ivermectin DOT (from 32.1%) – reductions of 62% and 94%, respectively – represented much larger decreases, “especially since these reductions were seen without any further interventions,” Dr. Whitfield said. “This was extremely exciting, and a game-changer as far as the management of endemic scabies is concerned.”

At baseline, impetigo rates hovered around 20%-25%, and usual care resulted in a 32% reduction at 12 months. With permethrin DOT, the impetigo rate dropped by 54%; with ivermectin DOT, the impetigo rate dropped by 67%. “The community level of impetigo went down, purely as a result of treating the scabies,” Dr. Whitfield said.

The outcomes of this study, she noted, “have contributed to the global discussion of the treatment of scabies.”

Two years after the mass drug administration (MDA) campaign, scabies prevalence remained much lower than at baseline, with clinical scabies diagnosed in 15.2% of the usual care group, 13.5% of the permethrin group, and just 3.6% of the ivermectin group. “The exciting thing for us was that these levels ... were able to be sustained at 2 years,” Dr. Whitfield noted.

The islands that had received ivermectin saw a continued decline in impetigo prevalence as well: By 24 months, impetigo was seen in 2.6% of participants in that arm.


Scabies is a neglected – but highly treatable – tropical disease, she noted. It is associated with intense pruritus, which results in reduced quality of life, and excoriations predispose those affected to bacterial superinfections, commonly impetigo in the young.

In Fiji, the scabies mite infests nearly 40% of those aged 5-9 years, and over one-third of those younger than 5 years. Rates drop steeply with increasing age and then climb again for the elderly; still, prevalence tops 10% for all Fijian age groups, Dr. Whitfield pointed out. Overall, scabies prevalence is 23% in Fiji, with resultant impetigo affecting 19% of the population.

Providing more details about the study, she said that she and her collaborators – working in conjunction with the Fijian Ministry of Health – took advantage of the geography of the island country, whose 850,000 residents live on 300 islands, to compare mass drug treatment with either ivermectin or permethrin with usual care. “We actually didn’t look for ‘infected scabies,’ ” she explained. “We looked for scabies as one outcome, and infection as another.”

The study was designed to take advantage of lessons from previous public health work addressing filariasis and soil-transmitted helminths, and addressed the following question: In Fiji, could a single round of MDA for scabies control lead to sustained reductions in scabies and impetigo prevalence 12 months later, compared with standard care?

For one MDA arm, island residents received oral ivermectin via DOT. A second DOT dose was administered for those with clinically diagnosed scabies. For pregnant and breastfeeding women, children weighing less than 15 kg, and those with ivermectin hypersensitivity, permethrin was used, Dr. Whitfield said.

The individuals in the permethrin MDA arm received one topical dose via DOT, with a second round of topical permethrin for those with topical scabies.

In all, 803 Fijians were assigned to receive standard of care, 532 permethrin MDA, and 716 ivermectin MDA. Of these, 623 received ivermectin DOT, and 93 received permethrin. In all, DOT was achieved for 96% of those receiving the first dose. At baseline, 230 patients had scabies, with 200 receiving ivermectin and 30 permethrin; the DOT rate was 100% for the second dose.

For the permethrin arm, just 307 of 532 participants (58%) had DOT, though all were given permethrin. Scabies was present at baseline for 222 participants, and of these, 181 had DOT. “It’s much easier to do the direct observed therapy with an oral medication than with a cream,” Dr. Whitfield said. Data were not collected for the Fijians who received usual care at community health centers.

Outcomes were clinically determined via the child skin assessment algorithm of the World Health Organization’s International Management of Childhood Illness (IMCI) guidelines.

Dr. Whitfield acknowledged that the study was not a true cluster-randomized trial, and differences existed between the communities studies. Also, “dermatoscopy was not a practical option” for this real-world trial in a resource-limited setting, but validated clinical criteria were used, she said.

Going forward, she and her colleagues are continuing to track durability of reduced scabies rates, as well as downstream sequelae such as impetigo and septicemia. Also, “we need to see whether this community- and island-based project could be scaled up to a national or regional level,” she said.

The burden of disease from scabies globally is probably underestimated, and changing migration patterns may bring endemic scabies to the doorsteps of more developed nations, prompting consideration of MDA as a strategy in expanded circumstances.

Dr. Whitfield reported that she had no relevant conflicts of interest.

[email protected]

MILAN – In a region where scabies is endemic, a strategy of mass drug treatment for scabies resulted in durable reduction of both scabies and impetigo, findings that may have implications for future treatment of scabies or other infestations in other regions, dermatologist Margot Whitfield, MD, said at the World Congress of Dermatology.

“Mass drug administration is highly effective and safe in the treatment of endemic scabies,” she said.

Using a strategy of directly observed treatment (DOT) with oral ivermectin or topical permethrin for all residents of two separate island groups in Fiji, Dr. Whitfield, together with epidemiologist Lucia Romani, PhD, both of the University of New South Wales, Sydney, and coinvestigators, demonstrated large and sustained decreases in the rates of scabies and impetigo (N Engl J Med. 2015 Dec 10;373[24]:2305-13).

Across study arms, which included a usual care arm, the baseline rate for scabies ranged from 30% to 40%. With usual care, the rate dropped from 36.6% to 18.8% at the end of 12 months, a relative reduction of 49%. However, the 15.8% prevalence rate 12 months after permethrin DOT (from 41.7%), and the 1.9% rate 12 months after ivermectin DOT (from 32.1%) – reductions of 62% and 94%, respectively – represented much larger decreases, “especially since these reductions were seen without any further interventions,” Dr. Whitfield said. “This was extremely exciting, and a game-changer as far as the management of endemic scabies is concerned.”

At baseline, impetigo rates hovered around 20%-25%, and usual care resulted in a 32% reduction at 12 months. With permethrin DOT, the impetigo rate dropped by 54%; with ivermectin DOT, the impetigo rate dropped by 67%. “The community level of impetigo went down, purely as a result of treating the scabies,” Dr. Whitfield said.

The outcomes of this study, she noted, “have contributed to the global discussion of the treatment of scabies.”

Two years after the mass drug administration (MDA) campaign, scabies prevalence remained much lower than at baseline, with clinical scabies diagnosed in 15.2% of the usual care group, 13.5% of the permethrin group, and just 3.6% of the ivermectin group. “The exciting thing for us was that these levels ... were able to be sustained at 2 years,” Dr. Whitfield noted.

The islands that had received ivermectin saw a continued decline in impetigo prevalence as well: By 24 months, impetigo was seen in 2.6% of participants in that arm.


Scabies is a neglected – but highly treatable – tropical disease, she noted. It is associated with intense pruritus, which results in reduced quality of life, and excoriations predispose those affected to bacterial superinfections, commonly impetigo in the young.

In Fiji, the scabies mite infests nearly 40% of those aged 5-9 years, and over one-third of those younger than 5 years. Rates drop steeply with increasing age and then climb again for the elderly; still, prevalence tops 10% for all Fijian age groups, Dr. Whitfield pointed out. Overall, scabies prevalence is 23% in Fiji, with resultant impetigo affecting 19% of the population.

Providing more details about the study, she said that she and her collaborators – working in conjunction with the Fijian Ministry of Health – took advantage of the geography of the island country, whose 850,000 residents live on 300 islands, to compare mass drug treatment with either ivermectin or permethrin with usual care. “We actually didn’t look for ‘infected scabies,’ ” she explained. “We looked for scabies as one outcome, and infection as another.”

The study was designed to take advantage of lessons from previous public health work addressing filariasis and soil-transmitted helminths, and addressed the following question: In Fiji, could a single round of MDA for scabies control lead to sustained reductions in scabies and impetigo prevalence 12 months later, compared with standard care?

For one MDA arm, island residents received oral ivermectin via DOT. A second DOT dose was administered for those with clinically diagnosed scabies. For pregnant and breastfeeding women, children weighing less than 15 kg, and those with ivermectin hypersensitivity, permethrin was used, Dr. Whitfield said.

The individuals in the permethrin MDA arm received one topical dose via DOT, with a second round of topical permethrin for those with topical scabies.

In all, 803 Fijians were assigned to receive standard of care, 532 permethrin MDA, and 716 ivermectin MDA. Of these, 623 received ivermectin DOT, and 93 received permethrin. In all, DOT was achieved for 96% of those receiving the first dose. At baseline, 230 patients had scabies, with 200 receiving ivermectin and 30 permethrin; the DOT rate was 100% for the second dose.

For the permethrin arm, just 307 of 532 participants (58%) had DOT, though all were given permethrin. Scabies was present at baseline for 222 participants, and of these, 181 had DOT. “It’s much easier to do the direct observed therapy with an oral medication than with a cream,” Dr. Whitfield said. Data were not collected for the Fijians who received usual care at community health centers.

Outcomes were clinically determined via the child skin assessment algorithm of the World Health Organization’s International Management of Childhood Illness (IMCI) guidelines.

Dr. Whitfield acknowledged that the study was not a true cluster-randomized trial, and differences existed between the communities studies. Also, “dermatoscopy was not a practical option” for this real-world trial in a resource-limited setting, but validated clinical criteria were used, she said.

Going forward, she and her colleagues are continuing to track durability of reduced scabies rates, as well as downstream sequelae such as impetigo and septicemia. Also, “we need to see whether this community- and island-based project could be scaled up to a national or regional level,” she said.

The burden of disease from scabies globally is probably underestimated, and changing migration patterns may bring endemic scabies to the doorsteps of more developed nations, prompting consideration of MDA as a strategy in expanded circumstances.

Dr. Whitfield reported that she had no relevant conflicts of interest.

[email protected]