As most of you already know, it’s been roughly 40 years since a new class of topical medications for eczema has been introduced. It was December 2000 when the Food and Drug Administration (FDA) announced approval of the first topical immunomodulator (TIM) — tacrolimus (Protopic) — giving dermatologists a breakthrough drug for treating this stubborn condition. Even though you may already use this steroid-free treatment for your eczema patients, find out how your colleagues are using this drug and what advice they have for improving treatment outcomes. For Starters Here’s what you need to know about tacrolimus: The 0.1% concentration is approved for treating adults, and the 0.03% concentration is approved for treating children 2 years old and older as well as adults for short-term and intermittent long-term therapy. It’s indicated for moderate to severe atopic eczema and unlike corticosteroids, tacrolimus is safe for dermatologic use anywhere on the body including the face and groin. The FDA based its approval on the results of three 12-week studies that indicated that 28% to 37% of patients using tacrolimus experienced greater than or equal to 90% improvement of their skin condition, as measured by physicians. Two 1-year studies also indicated that the drug is safe for intermittent long-term use. Common side effects associated with tacrolimus include temporary stinging or burning sensations where the drug is applied, which may lessen if the diseased skin heals. The Experts Weigh In We asked four leading dermatologists about their use of tacrolimus, specifically when treating children. Amy S. Paller, M.D., head of dermatology for Children’s Hospital in Chicago, explains that because by the time most of her patients see her, they’ve already gone through some type of therapy, she’s not able to use it as a first-line treatment. But, she says she frequently prescribes tacrolimus, and uses it as a first-line treatment for facial eczema. Denise W. Metry, M.D., says she often uses tacrolimus as a first-line approach for patients who have mild to moderate eczema “in which ‘patch’ describes the primary skin lesion, especially when the parents express concern regarding topical steroid use.” She uses topical steroids for a short time to control flares for patients who have moderate to severe patch-type eczema, but then she reverts back to tacrolimus. She points out, though, that “thicker, plaque-type eczema, which often occurs in darker-skinned patients, responds best to topical steroids.” Howard B. Pride, M.D., of Geisinger Medical Center’s department of dermatology, is a bit more trepidatious when using tacrolimus. He doesn’t use it as a first-line therapy for this reason: “I think that until it has been around longer and all of us get a feel for what age groups and types of eczema and such will respond best to treatment, it’s more just a matter of being familiar with other medications and less familiar with tacrolimus.” He’s not hesitant, however, to use it as a second-line therapy. “Many kids I see are referred to me and have already been through topical steroid treatments, so maybe I’d use it as a first line in these cases because these children have already been through my typical first-line treatment with other doctors.” Sheila Fallon-Friedlander, M.D., of pediatric and adolescent dermatology at Children’s Hospital and Health Center in San Diego, says she uses tacrolimus often, but only after a patient has failed standard therapies such as moisturizers, weak to mid-potency topical steroids or oral antibiotics, or if they can’t be weaned from topical steroids. Where Do They Apply It? The FDA and Fujisawa Healthcare have approved tacrolimus as safe to use dermatologically on all areas of the body. But on which areas of the body are your colleagues most often applying this ointment? They’re apparently going with approved indications because there’s no area of the body that they won’t apply tacrolimus. “The benefit of tacrolimus is that it doesn’t cause atrophy,” says Dr. Metry, who uses the drug on all areas of the body. “It works especially well on the face (including eyelids), which is an area where topical steroid use is of special concern,” she says. Says Dr. Pride, “I don’t know that there’s anywhere I wouldn’t use it — the palms of hands and the soles of feet are usually resistant, so expectations of success are a little lower there.” Dr. Paller seconds this statement but says that many of her patients’ hands and feet have responded well to tacrolimus. Dr. Fallon-Friedlander also uses the drug on all areas of the body. “It’s particularly useful on the face, where I don’t like to use topical corticosteroids for a prolonged period.” Targeting a Type What type of eczema responds best to this treatment? As Dr. Metry stated, she uses tacrolimus for patients with mild to moderate eczema in which “patch” describes the primary skin lesion. She also uses it on moderate to severe patch-type eczema after using topical steroids to control flare-ups. Dr. Paller says, “Anyone who has atopic dermatitis responds well to this treatment.” Dr. Pride points out that tacrolimus is only FDA approved to treat atopic dermatitis, “so facial eczema really stands out as an area you’d want to use it on, and it’s the least best place to use a steroid, so the face is ideal for tacrolimus.” Let’s take a closer look at how they rate this drug’s actual success at treating patients. A Statistical Perspective “A significant portion of the patients I see in my practice could benefit from tacrolimus therapy,” says Dr. Fallon-Friedlander. “The vast majority of patients who use tacrolimus respond. However, there may be initial stinging if the patient has eczema lesions that are cracked or open. Therefore, some patients may not be able to tolerate it. In these cases, patients benefit from pretreatment with topical steroids, and in some instances, oral antibiotics.” Dr. Paller cites the drug’s results in clinical trials. “Eighty percent of patients in trials benefited, but do many patients need tacrolimus? No. If you have a patient who’s using steroids on a continuing basis, then you want to look at other options.” More specifically, she says, “If you look at the studies, over a 12-week period, about 40% of patients became clear or virtually clear of their eczema symptoms, and I would call that a great response.” Dr. Pride contends that virtually every eczema patient can benefit from tacrolimus. “A lot depends on whether it’s a referral population or if we’re the first person treating the patient,” he explains. “Ninety percent will get some significant benefit from tacrolimus. You’re probably only looking at 10% for a child who has never been treated because a standard treatment will get him or her under control.” He adds that if you take all comers, mild to moderate, a significant number (80% to 90%) will have great results, but they’d also do well with a low-potency steroid. Maximizing Therapy These dermatologists shared some additional treatment pearls: l Dr. Metry really hones in on the issue of patient selection. “It’s important to select the right candidate,” she says. “Tacrolimus can cause some mild burning and pruritus (in about 20% of patients in the first week of treatment), which is temporary.” If this occurs, Dr. Metry instructs her patients’ parents to mix the tacrolimus 1:1 with an emollient until these side effects subside. l Dr. Paller also brings up the issue of tacrolimus causing burning and stinging, and she suggests using a medium-strength corticosteroid to decrease the incidence of these symptoms. She says that once patients pass this point, they should be fine. l Another point Dr. Metry emphasizes is that tacrolimus isn’t a substitute for frequent emollient use, which patients should use concomitantly. “And just as you would with steroids, you should only use tacrolimus on affected areas.” l Says Dr. Paller, “Tacrolimus is a particularly good treatment for lesions and facial eczema. It’s also appropriate for select children and adults as well as with patients who’ve advanced to the point where they have to use medium- strength steroids on a regular basis or who are unresponsive to steroids.” l Dr. Pride’s own feeling is that tacrolimus is a great medicine for the child who’s done well on topical steroids but who flares immediately after the steroid is discontinued. “It’s also good for those who have extensive facial eczema and who’ve been through multiple topical steroids but their condition isn’t getting better.” He does give one warning, though: “We’re fairly liberal with using creams, so we all need to be cautious using tacrolimus in significant surface areas that aren’t affected by eczema because there’s significant absorption of the medicine.” l Dr. Pride also says to use caution when experimenting with off-label use on large expanses of the body (especially on inflamed skin in small children). Dr. Metry echoes this consideration. She says, “Concerns remain regarding the potential for systemic absorption in our younger patients who have a higher body surface area/weight ratio.” l Dr. Paller adds one final note, saying, “In the spring, when the sun comes out, remind patients of sun protection. Although there’s no evidence linking tacrolimus to ultraviolet rays, we should make sure that we’re not putting children at risk. So remember to talk to parents about protecting their children from the sun with hats and appropriate clothing.” Proceed with Knowledge Tacrolimus has been available for treatment for more than a year now, and we’ve heard from several dermatologists who’ve used it and have seen promising results. Hopefully, you’ve gleaned some advice that will help you better treat your patients who are in need of new options for treating their persistent condition.
Immunomodulators in Action
As most of you already know, it’s been roughly 40 years since a new class of topical medications for eczema has been introduced. It was December 2000 when the Food and Drug Administration (FDA) announced approval of the first topical immunomodulator (TIM) — tacrolimus (Protopic) — giving dermatologists a breakthrough drug for treating this stubborn condition. Even though you may already use this steroid-free treatment for your eczema patients, find out how your colleagues are using this drug and what advice they have for improving treatment outcomes. For Starters Here’s what you need to know about tacrolimus: The 0.1% concentration is approved for treating adults, and the 0.03% concentration is approved for treating children 2 years old and older as well as adults for short-term and intermittent long-term therapy. It’s indicated for moderate to severe atopic eczema and unlike corticosteroids, tacrolimus is safe for dermatologic use anywhere on the body including the face and groin. The FDA based its approval on the results of three 12-week studies that indicated that 28% to 37% of patients using tacrolimus experienced greater than or equal to 90% improvement of their skin condition, as measured by physicians. Two 1-year studies also indicated that the drug is safe for intermittent long-term use. Common side effects associated with tacrolimus include temporary stinging or burning sensations where the drug is applied, which may lessen if the diseased skin heals. The Experts Weigh In We asked four leading dermatologists about their use of tacrolimus, specifically when treating children. Amy S. Paller, M.D., head of dermatology for Children’s Hospital in Chicago, explains that because by the time most of her patients see her, they’ve already gone through some type of therapy, she’s not able to use it as a first-line treatment. But, she says she frequently prescribes tacrolimus, and uses it as a first-line treatment for facial eczema. Denise W. Metry, M.D., says she often uses tacrolimus as a first-line approach for patients who have mild to moderate eczema “in which ‘patch’ describes the primary skin lesion, especially when the parents express concern regarding topical steroid use.” She uses topical steroids for a short time to control flares for patients who have moderate to severe patch-type eczema, but then she reverts back to tacrolimus. She points out, though, that “thicker, plaque-type eczema, which often occurs in darker-skinned patients, responds best to topical steroids.” Howard B. Pride, M.D., of Geisinger Medical Center’s department of dermatology, is a bit more trepidatious when using tacrolimus. He doesn’t use it as a first-line therapy for this reason: “I think that until it has been around longer and all of us get a feel for what age groups and types of eczema and such will respond best to treatment, it’s more just a matter of being familiar with other medications and less familiar with tacrolimus.” He’s not hesitant, however, to use it as a second-line therapy. “Many kids I see are referred to me and have already been through topical steroid treatments, so maybe I’d use it as a first line in these cases because these children have already been through my typical first-line treatment with other doctors.” Sheila Fallon-Friedlander, M.D., of pediatric and adolescent dermatology at Children’s Hospital and Health Center in San Diego, says she uses tacrolimus often, but only after a patient has failed standard therapies such as moisturizers, weak to mid-potency topical steroids or oral antibiotics, or if they can’t be weaned from topical steroids. Where Do They Apply It? The FDA and Fujisawa Healthcare have approved tacrolimus as safe to use dermatologically on all areas of the body. But on which areas of the body are your colleagues most often applying this ointment? They’re apparently going with approved indications because there’s no area of the body that they won’t apply tacrolimus. “The benefit of tacrolimus is that it doesn’t cause atrophy,” says Dr. Metry, who uses the drug on all areas of the body. “It works especially well on the face (including eyelids), which is an area where topical steroid use is of special concern,” she says. Says Dr. Pride, “I don’t know that there’s anywhere I wouldn’t use it — the palms of hands and the soles of feet are usually resistant, so expectations of success are a little lower there.” Dr. Paller seconds this statement but says that many of her patients’ hands and feet have responded well to tacrolimus. Dr. Fallon-Friedlander also uses the drug on all areas of the body. “It’s particularly useful on the face, where I don’t like to use topical corticosteroids for a prolonged period.” Targeting a Type What type of eczema responds best to this treatment? As Dr. Metry stated, she uses tacrolimus for patients with mild to moderate eczema in which “patch” describes the primary skin lesion. She also uses it on moderate to severe patch-type eczema after using topical steroids to control flare-ups. Dr. Paller says, “Anyone who has atopic dermatitis responds well to this treatment.” Dr. Pride points out that tacrolimus is only FDA approved to treat atopic dermatitis, “so facial eczema really stands out as an area you’d want to use it on, and it’s the least best place to use a steroid, so the face is ideal for tacrolimus.” Let’s take a closer look at how they rate this drug’s actual success at treating patients. A Statistical Perspective “A significant portion of the patients I see in my practice could benefit from tacrolimus therapy,” says Dr. Fallon-Friedlander. “The vast majority of patients who use tacrolimus respond. However, there may be initial stinging if the patient has eczema lesions that are cracked or open. Therefore, some patients may not be able to tolerate it. In these cases, patients benefit from pretreatment with topical steroids, and in some instances, oral antibiotics.” Dr. Paller cites the drug’s results in clinical trials. “Eighty percent of patients in trials benefited, but do many patients need tacrolimus? No. If you have a patient who’s using steroids on a continuing basis, then you want to look at other options.” More specifically, she says, “If you look at the studies, over a 12-week period, about 40% of patients became clear or virtually clear of their eczema symptoms, and I would call that a great response.” Dr. Pride contends that virtually every eczema patient can benefit from tacrolimus. “A lot depends on whether it’s a referral population or if we’re the first person treating the patient,” he explains. “Ninety percent will get some significant benefit from tacrolimus. You’re probably only looking at 10% for a child who has never been treated because a standard treatment will get him or her under control.” He adds that if you take all comers, mild to moderate, a significant number (80% to 90%) will have great results, but they’d also do well with a low-potency steroid. Maximizing Therapy These dermatologists shared some additional treatment pearls: l Dr. Metry really hones in on the issue of patient selection. “It’s important to select the right candidate,” she says. “Tacrolimus can cause some mild burning and pruritus (in about 20% of patients in the first week of treatment), which is temporary.” If this occurs, Dr. Metry instructs her patients’ parents to mix the tacrolimus 1:1 with an emollient until these side effects subside. l Dr. Paller also brings up the issue of tacrolimus causing burning and stinging, and she suggests using a medium-strength corticosteroid to decrease the incidence of these symptoms. She says that once patients pass this point, they should be fine. l Another point Dr. Metry emphasizes is that tacrolimus isn’t a substitute for frequent emollient use, which patients should use concomitantly. “And just as you would with steroids, you should only use tacrolimus on affected areas.” l Says Dr. Paller, “Tacrolimus is a particularly good treatment for lesions and facial eczema. It’s also appropriate for select children and adults as well as with patients who’ve advanced to the point where they have to use medium- strength steroids on a regular basis or who are unresponsive to steroids.” l Dr. Pride’s own feeling is that tacrolimus is a great medicine for the child who’s done well on topical steroids but who flares immediately after the steroid is discontinued. “It’s also good for those who have extensive facial eczema and who’ve been through multiple topical steroids but their condition isn’t getting better.” He does give one warning, though: “We’re fairly liberal with using creams, so we all need to be cautious using tacrolimus in significant surface areas that aren’t affected by eczema because there’s significant absorption of the medicine.” l Dr. Pride also says to use caution when experimenting with off-label use on large expanses of the body (especially on inflamed skin in small children). Dr. Metry echoes this consideration. She says, “Concerns remain regarding the potential for systemic absorption in our younger patients who have a higher body surface area/weight ratio.” l Dr. Paller adds one final note, saying, “In the spring, when the sun comes out, remind patients of sun protection. Although there’s no evidence linking tacrolimus to ultraviolet rays, we should make sure that we’re not putting children at risk. So remember to talk to parents about protecting their children from the sun with hats and appropriate clothing.” Proceed with Knowledge Tacrolimus has been available for treatment for more than a year now, and we’ve heard from several dermatologists who’ve used it and have seen promising results. Hopefully, you’ve gleaned some advice that will help you better treat your patients who are in need of new options for treating their persistent condition.
As most of you already know, it’s been roughly 40 years since a new class of topical medications for eczema has been introduced. It was December 2000 when the Food and Drug Administration (FDA) announced approval of the first topical immunomodulator (TIM) — tacrolimus (Protopic) — giving dermatologists a breakthrough drug for treating this stubborn condition. Even though you may already use this steroid-free treatment for your eczema patients, find out how your colleagues are using this drug and what advice they have for improving treatment outcomes. For Starters Here’s what you need to know about tacrolimus: The 0.1% concentration is approved for treating adults, and the 0.03% concentration is approved for treating children 2 years old and older as well as adults for short-term and intermittent long-term therapy. It’s indicated for moderate to severe atopic eczema and unlike corticosteroids, tacrolimus is safe for dermatologic use anywhere on the body including the face and groin. The FDA based its approval on the results of three 12-week studies that indicated that 28% to 37% of patients using tacrolimus experienced greater than or equal to 90% improvement of their skin condition, as measured by physicians. Two 1-year studies also indicated that the drug is safe for intermittent long-term use. Common side effects associated with tacrolimus include temporary stinging or burning sensations where the drug is applied, which may lessen if the diseased skin heals. The Experts Weigh In We asked four leading dermatologists about their use of tacrolimus, specifically when treating children. Amy S. Paller, M.D., head of dermatology for Children’s Hospital in Chicago, explains that because by the time most of her patients see her, they’ve already gone through some type of therapy, she’s not able to use it as a first-line treatment. But, she says she frequently prescribes tacrolimus, and uses it as a first-line treatment for facial eczema. Denise W. Metry, M.D., says she often uses tacrolimus as a first-line approach for patients who have mild to moderate eczema “in which ‘patch’ describes the primary skin lesion, especially when the parents express concern regarding topical steroid use.” She uses topical steroids for a short time to control flares for patients who have moderate to severe patch-type eczema, but then she reverts back to tacrolimus. She points out, though, that “thicker, plaque-type eczema, which often occurs in darker-skinned patients, responds best to topical steroids.” Howard B. Pride, M.D., of Geisinger Medical Center’s department of dermatology, is a bit more trepidatious when using tacrolimus. He doesn’t use it as a first-line therapy for this reason: “I think that until it has been around longer and all of us get a feel for what age groups and types of eczema and such will respond best to treatment, it’s more just a matter of being familiar with other medications and less familiar with tacrolimus.” He’s not hesitant, however, to use it as a second-line therapy. “Many kids I see are referred to me and have already been through topical steroid treatments, so maybe I’d use it as a first line in these cases because these children have already been through my typical first-line treatment with other doctors.” Sheila Fallon-Friedlander, M.D., of pediatric and adolescent dermatology at Children’s Hospital and Health Center in San Diego, says she uses tacrolimus often, but only after a patient has failed standard therapies such as moisturizers, weak to mid-potency topical steroids or oral antibiotics, or if they can’t be weaned from topical steroids. Where Do They Apply It? The FDA and Fujisawa Healthcare have approved tacrolimus as safe to use dermatologically on all areas of the body. But on which areas of the body are your colleagues most often applying this ointment? They’re apparently going with approved indications because there’s no area of the body that they won’t apply tacrolimus. “The benefit of tacrolimus is that it doesn’t cause atrophy,” says Dr. Metry, who uses the drug on all areas of the body. “It works especially well on the face (including eyelids), which is an area where topical steroid use is of special concern,” she says. Says Dr. Pride, “I don’t know that there’s anywhere I wouldn’t use it — the palms of hands and the soles of feet are usually resistant, so expectations of success are a little lower there.” Dr. Paller seconds this statement but says that many of her patients’ hands and feet have responded well to tacrolimus. Dr. Fallon-Friedlander also uses the drug on all areas of the body. “It’s particularly useful on the face, where I don’t like to use topical corticosteroids for a prolonged period.” Targeting a Type What type of eczema responds best to this treatment? As Dr. Metry stated, she uses tacrolimus for patients with mild to moderate eczema in which “patch” describes the primary skin lesion. She also uses it on moderate to severe patch-type eczema after using topical steroids to control flare-ups. Dr. Paller says, “Anyone who has atopic dermatitis responds well to this treatment.” Dr. Pride points out that tacrolimus is only FDA approved to treat atopic dermatitis, “so facial eczema really stands out as an area you’d want to use it on, and it’s the least best place to use a steroid, so the face is ideal for tacrolimus.” Let’s take a closer look at how they rate this drug’s actual success at treating patients. A Statistical Perspective “A significant portion of the patients I see in my practice could benefit from tacrolimus therapy,” says Dr. Fallon-Friedlander. “The vast majority of patients who use tacrolimus respond. However, there may be initial stinging if the patient has eczema lesions that are cracked or open. Therefore, some patients may not be able to tolerate it. In these cases, patients benefit from pretreatment with topical steroids, and in some instances, oral antibiotics.” Dr. Paller cites the drug’s results in clinical trials. “Eighty percent of patients in trials benefited, but do many patients need tacrolimus? No. If you have a patient who’s using steroids on a continuing basis, then you want to look at other options.” More specifically, she says, “If you look at the studies, over a 12-week period, about 40% of patients became clear or virtually clear of their eczema symptoms, and I would call that a great response.” Dr. Pride contends that virtually every eczema patient can benefit from tacrolimus. “A lot depends on whether it’s a referral population or if we’re the first person treating the patient,” he explains. “Ninety percent will get some significant benefit from tacrolimus. You’re probably only looking at 10% for a child who has never been treated because a standard treatment will get him or her under control.” He adds that if you take all comers, mild to moderate, a significant number (80% to 90%) will have great results, but they’d also do well with a low-potency steroid. Maximizing Therapy These dermatologists shared some additional treatment pearls: l Dr. Metry really hones in on the issue of patient selection. “It’s important to select the right candidate,” she says. “Tacrolimus can cause some mild burning and pruritus (in about 20% of patients in the first week of treatment), which is temporary.” If this occurs, Dr. Metry instructs her patients’ parents to mix the tacrolimus 1:1 with an emollient until these side effects subside. l Dr. Paller also brings up the issue of tacrolimus causing burning and stinging, and she suggests using a medium-strength corticosteroid to decrease the incidence of these symptoms. She says that once patients pass this point, they should be fine. l Another point Dr. Metry emphasizes is that tacrolimus isn’t a substitute for frequent emollient use, which patients should use concomitantly. “And just as you would with steroids, you should only use tacrolimus on affected areas.” l Says Dr. Paller, “Tacrolimus is a particularly good treatment for lesions and facial eczema. It’s also appropriate for select children and adults as well as with patients who’ve advanced to the point where they have to use medium- strength steroids on a regular basis or who are unresponsive to steroids.” l Dr. Pride’s own feeling is that tacrolimus is a great medicine for the child who’s done well on topical steroids but who flares immediately after the steroid is discontinued. “It’s also good for those who have extensive facial eczema and who’ve been through multiple topical steroids but their condition isn’t getting better.” He does give one warning, though: “We’re fairly liberal with using creams, so we all need to be cautious using tacrolimus in significant surface areas that aren’t affected by eczema because there’s significant absorption of the medicine.” l Dr. Pride also says to use caution when experimenting with off-label use on large expanses of the body (especially on inflamed skin in small children). Dr. Metry echoes this consideration. She says, “Concerns remain regarding the potential for systemic absorption in our younger patients who have a higher body surface area/weight ratio.” l Dr. Paller adds one final note, saying, “In the spring, when the sun comes out, remind patients of sun protection. Although there’s no evidence linking tacrolimus to ultraviolet rays, we should make sure that we’re not putting children at risk. So remember to talk to parents about protecting their children from the sun with hats and appropriate clothing.” Proceed with Knowledge Tacrolimus has been available for treatment for more than a year now, and we’ve heard from several dermatologists who’ve used it and have seen promising results. Hopefully, you’ve gleaned some advice that will help you better treat your patients who are in need of new options for treating their persistent condition.
