Psoriatic Arthritis

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

A version of this article first appeared on Medscape.com.

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

A version of this article first appeared on Medscape.com.

Patients with rheumatic and musculoskeletal diseases may need additional vaccines or different versions of vaccines they were not previously recommended to receive, according to updated guidelines from the American College of Rheumatology (ACR) on vaccinations for these patients. The new guidelines pertain to routine vaccinations for adults and children and are based on the most current evidence. They include recommendations on whether to hold certain medications before or after vaccination. They do not include recommendations regarding COVID-19 vaccines.

For guidance on COVID-19 vaccine timing and frequency, the ACR directs physicians to the CDC’s recommendations for people with mild or severe immunosuppression and the ACR’s previous clinical guidance summary on the topic, last revised in February 2022. The recommendations in the new guidance differ from ACR’s guidance on COVID-19 vaccines on whether and when to hold immunosuppressive medications when patients receive nonlive vaccines. The new guidelines now align more closely with those of EULAR, the Infectious Diseases Society of America, and the CDC’s recommendations for human papillomavirus (HPV), pneumococcal, and shingles vaccines.

MarianVejcik/Getty Images

Vaccinations in this population are particularly important because “a leading cause of morbidity and mortality in those with rheumatic diseases is infections, due to the detrimental impact immunosuppression has on the ability for the patient to properly clear the pathogen,” Alfred Kim, MD, PhD, professor of rheumatology at Washington University, St. Louis, told this news organization. While immunosuppressive medications are the most common reason patients with these conditions may have impaired immune function, “some of our patients with autoimmune disease also have a preexisting immunodeficiency that can inherently blunt immune responses to either infection or vaccination,” Dr. Kim explained.

“The authors of the guidelines have done a really nice job of making distinct recommendations based on the mechanism of action of various immunosuppressive medications,” Dr. Kim said. “This helps simplify the process of deciding the timing of vaccination for the health provider, especially for those on multiple immunosuppressives who represent an important proportion of our patients with rheumatic diseases.”

The main change to the guidelines for children, aside from those related to flu vaccination, is in regard to rotavirus vaccination for infants exposed to tumor necrosis factor (TNF) inhibitors or rituximab in utero. Infants prenatally exposed to rituximab should not receive the rotavirus vaccine until they are older than 6 months. Those exposed prenatally to TNF inhibitors should receive the rotavirus vaccine on time, according to the CDC schedule for all infants.

The new rotavirus recommendations follow data showing that immune responses to rotavirus are blunted in those with infliximab exposure, according to Dr. Kim.

“Thus, this poses a serious theoretical risk in newborns with mothers on [a TNF inhibitor] of ineffective clearance of rotavirus infections,” Dr. Kim said in an interview. “While rotavirus infections are quite common with typically self-limiting disease, sometimes requiring hydration to counteract diarrhea-induced dehydration, this can become severe in these newborns that have [a TNF inhibitor] in their system.”

For adults, the ACR issued the following expanded indications for four vaccines for patients currently taking immunosuppressive medication:

• Patients aged 18 and older should receive the recombinant zoster vaccine against shingles.
• For patients aged 27-44 who weren’t previously vaccinated against HPV, the HPV vaccine is “conditionally recommended.”
• Patients younger than 65 should receive the pneumococcal vaccine.
• Patients aged 19-64 are conditionally recommended to receive the high-dose or adjuvanted flu vaccine rather than the regular-dose flu vaccine.

The guidelines also conditionally recommend that all patients aged 65 and older who have rheumatic or musculoskeletal diseases receive the high-dose or adjuvanted flu vaccine, regardless of whether they are taking immunosuppressive medication. Another new conditional recommendation is to give multiple vaccinations to patients on the same day, rather than give individual vaccines on different days.

The guidelines make conditional recommendations regarding flu and nonlive attenuated vaccines for those taking methotrexate, rituximab, or glucocorticoids. Methotrexate should be held for 2 weeks after flu vaccination as long as disease activity allows it, but patients who are taking methotrexate should continue taking it for any other nonlive attenuated vaccinations.

“Non-rheumatology providers, such as general pediatricians and internists, are encouraged to give the influenza vaccination and then consult with the patient’s rheumatology provider about holding methotrexate to avoid a missed vaccination opportunity,” the guidelines state.

Patients taking rituximab should receive the flu vaccine on schedule and continue taking rituximab. However, for these patients, the guidelines recommend to “delay any subsequent rituximab dosing for at least two weeks after influenza vaccination if disease activity allows.”

“Because of the relatively short time period between the rollout of the influenza vaccine and its season, we can’t always wait to time the B-cell depletion dosage,” Dr. Kim said. “Also, it is not always easy to synchronize the patient’s B-cell depletion dosing schedule to the influenza vaccine rollout. Thus, we now just recommend getting the influenza vaccine regardless of the patient’s last B-cell depletion dosage despite its known strong attenuation of optimal immune responses.”

For other nonlive attenuated vaccines, providers should time vaccination for when the next rituximab dose is due and then hold the drug for at least 2 weeks thereafter, providing time for the B cells to mount a response before rituximab depletes B cells again.

Patients taking less than 20 mg of prednisone daily should still receive the flu vaccine and other nonlive attenuated vaccines. Those taking 20 mg or more of prednisone each day should still receive the flu vaccine, but other vaccines should be deferred until their dose of glucocorticoids has been tapered down to less than 20 mg daily.

Patients taking all other immunosuppressive medications should continue taking them for the flu vaccine and other nonlive attenuated vaccinations, but it is conditionally recommended that live attenuated vaccines be deferred. For any patient with a rheumatic and musculoskeletal disease, regardless of disease activity, it is conditionally recommended that all routine nonlive attenuated vaccines be administered.

For live attenuated virus vaccines, the ACR provides a chart on which immunosuppressive medications to hold and for how long. Glucocorticoids, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, calcineurin inhibitors, and oral cyclophosphamide should all be held 4 weeks before and 4 weeks after administration of a live attenuated vaccine. For those taking JAK inhibitors, the medication should be halted 1 week before administration of a live vaccine and should continue to be withheld for 4 weeks after.

For most other biologics, the ACR recommends holding the medication for one dosing interval before the live vaccine and 4 weeks thereafter. The main exception is rituximab, which should be held for 6 months before a live vaccine and then for 4 more weeks thereafter.

For patients receiving intravenous immunoglobulin, the drug should be held for 8-11 months before they are administered a live attenuated vaccine, depending on the dosage, and then 4 weeks after vaccination, regardless of dosage.

To reassure people with rheumatic disease who may have anxiety or concerns about receiving immunizations, whether taking immunosuppressive medication or not, Dr. Kim said it’s important to provide lots of education to patients.

“Fear and emotion have replaced facts, and data as a leading factor in decision-making, as seen with COVID-19,” Dr. Kim said. “The reality is that a small minority of people will have any issues with most vaccines, which include disease flares, adverse events, or acquisition of an autoimmune disease. We are not saying there is zero risk, rather, that the risk is quite small. This is where shared decision-making between the health care provider and the patient must be done effectively to enable the patient to properly weigh risk versus benefit.”

Dr. Kim has relationships with GlaxoSmithKline, Aurinia Pharmaceuticals, Kypha, Pfizer, Alexion Pharmaceuticals, AstraZeneca, Exagen Diagnostics, and Foghorn Therapeutics.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the dual interleukin-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in patients aged 6 years and older, according to an Aug. 1 announcement from its manufacturer, Janssen.

The approval makes jPsA the sixth approved indication for ustekinumab, which include active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children aged 6 years or older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease in adults, and moderately to severely active ulcerative colitis in adults.

In addition, ustekinumab is now the second biologic to be approved for jPsA, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat jPsA in children and adolescents aged 2 years and older as well as enthesitis-related arthritis in children and adolescents aged 4 years and older.

In pediatric patients, ustekinumab is administered as a subcutaneous injection dosed four times per year after two starter doses.

Ustekinumab’s approval is based on “an extrapolation of the established data and existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA, according to Janssen.

“With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the October 2021 announcement from the company that the Biologics License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20-45 children per 100,000 in the United States, with about 5% of those children having jPsA, according to the National Psoriasis Foundation.

The prescribing information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to individuals with known hypersensitivity to ustekinumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, sometimes serious, and a test for tuberculosis infection should be given before administration.

Patients taking ustekinumab should not be given a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine during the 1 year before receiving the drug or 1 year after they stop taking it, according to Johnson & Johnson.

The most common adverse effects include nasal congestion, sore throat, runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

A version of this article first appeared on Medscape.com.

Biomechanical stress and trauma are important factors driving the development and progression of psoriatic arthritis (PsA). On the other hand, physical exercise is beneficial for patients with arthritis. However, there is concern that high-intensity interval training (HIIT) may worsen PsA. Hypothesizing that bone marrow edema changes could occur in patients with PsA after HIIT despite no reported changes in disease activity by clinical examination, Chronaiou and colleagues aimed to assess whether HIIT in PsA patients led to MRI-detectable changes in the axial skeleton. Comparing 19 PsA patients who went through 11 weeks of HIIT with 20 patients who had no change in physical exercise habits, they found no significant changes in bone marrow edema on MRI images of the spine after HIIT. Thus, the 11-week HIIT regimen may be safe in PsA.

Mental health problems are often underestimated in psoriatic disease. Lada and colleagues aimed to estimate the prevalence of depression in patients with psoriatic disease and determine whether PsA is associated with higher depression and anxiety in patients with psoriasis. Analyzing data from British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) participants (540 with psoriasis and 167 with both psoriasis and PsA) who had completed the Hospital Anxiety and Depression Scale (HADS), they found that the prevalence of depression was higher in patients with PsA (32%) than in patients without PsA (22.7%) using a HADS cutoff of 8 (odds ratio 1.66; 95% CI 1.13--2.43). Pain mediated the effect of PsA on depression and anxiety.

Inhibitors of interleukin (IL)-23 are safe and efficacious in the treatment of psoriasis and PsA. However, changes in composite PsA indices have not been investigated in detail. Using pooled data from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies, Coates and colleagues demonstrated that a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks vs placebo achieved low disease activity according to the Disease Activity Index for PsA (DAPSA) at week 8 (19.8%/17.3% vs 8.1%), DAPSA remission at week 12 (4.3%/4.3% vs 0.5%), minimal disease activity at week 16 (14.7%/16.5% vs 4.6%; all P < .001), and very low disease activity at week 24 (6.4%/4.3% vs 1.3%; P < .05), with improvements maintained until week 52. Thus, compared with placebo, treatment with guselkumab leads to early and sustained benefits for patients with PsA.

Similarly, Ostor and colleagues demonstrated in the phase 3 KEEPsAKE2 trial, which included 443 patients with PsA, that, at week 24, patients receiving risankizumab report a significantly greater improvement in the mean pain index score (-14.7 vs -6.5; P < .001), fatigue score (4.9 vs 2.6; P < .01), patient's global assessment of disease activity (-16.5 vs -7.7; P < .001), general health status (0.09 vs 0.01; P < .001), and physical functioning (5.1 vs 2.0; P < .001) compared with placebo.

In another study, treatment with bimekizumab, an inhibitor of IL-17A and IL-17F, was associated with sustained improvement in patient-reported outcomes. Mease and colleagues report that, at week 48, there was a substantial improvement in mean arthritis pain (29.9 points), fatigue (2.4 points), Health Assessment Questionnaire-Disability Index (0.43 points), and Physical Component Summary score (9.1 points), with improvements sustained till week 152. High proportions of patients achieved the Patient Acceptable Symptom State at weeks 48 (75.2%) and 152 (65.0%). Thus, inhibitors of IL-23 and IL-17 have established efficacy in the treatment of PsA.

Biomechanical stress and trauma are important factors driving the development and progression of psoriatic arthritis (PsA). On the other hand, physical exercise is beneficial for patients with arthritis. However, there is concern that high-intensity interval training (HIIT) may worsen PsA. Hypothesizing that bone marrow edema changes could occur in patients with PsA after HIIT despite no reported changes in disease activity by clinical examination, Chronaiou and colleagues aimed to assess whether HIIT in PsA patients led to MRI-detectable changes in the axial skeleton. Comparing 19 PsA patients who went through 11 weeks of HIIT with 20 patients who had no change in physical exercise habits, they found no significant changes in bone marrow edema on MRI images of the spine after HIIT. Thus, the 11-week HIIT regimen may be safe in PsA.

Mental health problems are often underestimated in psoriatic disease. Lada and colleagues aimed to estimate the prevalence of depression in patients with psoriatic disease and determine whether PsA is associated with higher depression and anxiety in patients with psoriasis. Analyzing data from British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) participants (540 with psoriasis and 167 with both psoriasis and PsA) who had completed the Hospital Anxiety and Depression Scale (HADS), they found that the prevalence of depression was higher in patients with PsA (32%) than in patients without PsA (22.7%) using a HADS cutoff of 8 (odds ratio 1.66; 95% CI 1.13--2.43). Pain mediated the effect of PsA on depression and anxiety.

Inhibitors of interleukin (IL)-23 are safe and efficacious in the treatment of psoriasis and PsA. However, changes in composite PsA indices have not been investigated in detail. Using pooled data from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies, Coates and colleagues demonstrated that a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks vs placebo achieved low disease activity according to the Disease Activity Index for PsA (DAPSA) at week 8 (19.8%/17.3% vs 8.1%), DAPSA remission at week 12 (4.3%/4.3% vs 0.5%), minimal disease activity at week 16 (14.7%/16.5% vs 4.6%; all P < .001), and very low disease activity at week 24 (6.4%/4.3% vs 1.3%; P < .05), with improvements maintained until week 52. Thus, compared with placebo, treatment with guselkumab leads to early and sustained benefits for patients with PsA.

Similarly, Ostor and colleagues demonstrated in the phase 3 KEEPsAKE2 trial, which included 443 patients with PsA, that, at week 24, patients receiving risankizumab report a significantly greater improvement in the mean pain index score (-14.7 vs -6.5; P < .001), fatigue score (4.9 vs 2.6; P < .01), patient's global assessment of disease activity (-16.5 vs -7.7; P < .001), general health status (0.09 vs 0.01; P < .001), and physical functioning (5.1 vs 2.0; P < .001) compared with placebo.

In another study, treatment with bimekizumab, an inhibitor of IL-17A and IL-17F, was associated with sustained improvement in patient-reported outcomes. Mease and colleagues report that, at week 48, there was a substantial improvement in mean arthritis pain (29.9 points), fatigue (2.4 points), Health Assessment Questionnaire-Disability Index (0.43 points), and Physical Component Summary score (9.1 points), with improvements sustained till week 152. High proportions of patients achieved the Patient Acceptable Symptom State at weeks 48 (75.2%) and 152 (65.0%). Thus, inhibitors of IL-23 and IL-17 have established efficacy in the treatment of PsA.

Biomechanical stress and trauma are important factors driving the development and progression of psoriatic arthritis (PsA). On the other hand, physical exercise is beneficial for patients with arthritis. However, there is concern that high-intensity interval training (HIIT) may worsen PsA. Hypothesizing that bone marrow edema changes could occur in patients with PsA after HIIT despite no reported changes in disease activity by clinical examination, Chronaiou and colleagues aimed to assess whether HIIT in PsA patients led to MRI-detectable changes in the axial skeleton. Comparing 19 PsA patients who went through 11 weeks of HIIT with 20 patients who had no change in physical exercise habits, they found no significant changes in bone marrow edema on MRI images of the spine after HIIT. Thus, the 11-week HIIT regimen may be safe in PsA.

Mental health problems are often underestimated in psoriatic disease. Lada and colleagues aimed to estimate the prevalence of depression in patients with psoriatic disease and determine whether PsA is associated with higher depression and anxiety in patients with psoriasis. Analyzing data from British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) participants (540 with psoriasis and 167 with both psoriasis and PsA) who had completed the Hospital Anxiety and Depression Scale (HADS), they found that the prevalence of depression was higher in patients with PsA (32%) than in patients without PsA (22.7%) using a HADS cutoff of 8 (odds ratio 1.66; 95% CI 1.13--2.43). Pain mediated the effect of PsA on depression and anxiety.

Inhibitors of interleukin (IL)-23 are safe and efficacious in the treatment of psoriasis and PsA. However, changes in composite PsA indices have not been investigated in detail. Using pooled data from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies, Coates and colleagues demonstrated that a significantly higher proportion of patients receiving guselkumab every 4 or 8 weeks vs placebo achieved low disease activity according to the Disease Activity Index for PsA (DAPSA) at week 8 (19.8%/17.3% vs 8.1%), DAPSA remission at week 12 (4.3%/4.3% vs 0.5%), minimal disease activity at week 16 (14.7%/16.5% vs 4.6%; all P < .001), and very low disease activity at week 24 (6.4%/4.3% vs 1.3%; P < .05), with improvements maintained until week 52. Thus, compared with placebo, treatment with guselkumab leads to early and sustained benefits for patients with PsA.

Similarly, Ostor and colleagues demonstrated in the phase 3 KEEPsAKE2 trial, which included 443 patients with PsA, that, at week 24, patients receiving risankizumab report a significantly greater improvement in the mean pain index score (-14.7 vs -6.5; P < .001), fatigue score (4.9 vs 2.6; P < .01), patient's global assessment of disease activity (-16.5 vs -7.7; P < .001), general health status (0.09 vs 0.01; P < .001), and physical functioning (5.1 vs 2.0; P < .001) compared with placebo.

In another study, treatment with bimekizumab, an inhibitor of IL-17A and IL-17F, was associated with sustained improvement in patient-reported outcomes. Mease and colleagues report that, at week 48, there was a substantial improvement in mean arthritis pain (29.9 points), fatigue (2.4 points), Health Assessment Questionnaire-Disability Index (0.43 points), and Physical Component Summary score (9.1 points), with improvements sustained till week 152. High proportions of patients achieved the Patient Acceptable Symptom State at weeks 48 (75.2%) and 152 (65.0%). Thus, inhibitors of IL-23 and IL-17 have established efficacy in the treatment of PsA.

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: The 11-week high intensity interval training (HIIT) regimen had no influence on the bone marrow edema (BME) in patients with psoriatic arthritis (PsA).

Major finding: After 11 weeks, similar proportions of patients in the HIIT and control (no changes in exercise regimen) groups had BME changes, as assessed by a radiologist (P  =  .5) and SpondyloArthritis Research Consortium of Canada scores (P  =  1). Although the values of 20 textural features were significantly different in the voxels of BME vs healthy bone marrow (P < .001), the textural features of PsA lesions were similar between the HIIT and control groups (P > .2).

Study details: Findings are from the analysis of a part of a randomized controlled trial including 37 patients with PsA who performed HIIT 3 times/week for 11 weeks or followed the control regimen and were evaluated by MRI.

Disclosures: This research was funded by Norwegian Extra Foundation for Health and Rehabilitation and Sør-Trøndelag University college. The authors declared no conflicts of interest.

Source: Chronaiou I et al. Evaluating the impact of high intensity interval training on axial psoriatic arthritis based on MR images. Diagnostics (Basel). 2022;12(6):1420 (Jun 8). Doi: 10.3390/diagnostics12061420

Key clinical point: The 11-week high intensity interval training (HIIT) regimen had no influence on the bone marrow edema (BME) in patients with psoriatic arthritis (PsA).

Major finding: After 11 weeks, similar proportions of patients in the HIIT and control (no changes in exercise regimen) groups had BME changes, as assessed by a radiologist (P  =  .5) and SpondyloArthritis Research Consortium of Canada scores (P  =  1). Although the values of 20 textural features were significantly different in the voxels of BME vs healthy bone marrow (P < .001), the textural features of PsA lesions were similar between the HIIT and control groups (P > .2).

Study details: Findings are from the analysis of a part of a randomized controlled trial including 37 patients with PsA who performed HIIT 3 times/week for 11 weeks or followed the control regimen and were evaluated by MRI.

Disclosures: This research was funded by Norwegian Extra Foundation for Health and Rehabilitation and Sør-Trøndelag University college. The authors declared no conflicts of interest.

Source: Chronaiou I et al. Evaluating the impact of high intensity interval training on axial psoriatic arthritis based on MR images. Diagnostics (Basel). 2022;12(6):1420 (Jun 8). Doi: 10.3390/diagnostics12061420

Key clinical point: The 11-week high intensity interval training (HIIT) regimen had no influence on the bone marrow edema (BME) in patients with psoriatic arthritis (PsA).

Major finding: After 11 weeks, similar proportions of patients in the HIIT and control (no changes in exercise regimen) groups had BME changes, as assessed by a radiologist (P  =  .5) and SpondyloArthritis Research Consortium of Canada scores (P  =  1). Although the values of 20 textural features were significantly different in the voxels of BME vs healthy bone marrow (P < .001), the textural features of PsA lesions were similar between the HIIT and control groups (P > .2).

Study details: Findings are from the analysis of a part of a randomized controlled trial including 37 patients with PsA who performed HIIT 3 times/week for 11 weeks or followed the control regimen and were evaluated by MRI.

Disclosures: This research was funded by Norwegian Extra Foundation for Health and Rehabilitation and Sør-Trøndelag University college. The authors declared no conflicts of interest.

Source: Chronaiou I et al. Evaluating the impact of high intensity interval training on axial psoriatic arthritis based on MR images. Diagnostics (Basel). 2022;12(6):1420 (Jun 8). Doi: 10.3390/diagnostics12061420

Key clinical point: Patients with concomitant psoriasis and psoriatic arthritis (PsA) vs only psoriasis were more likely to experience mild depressive symptoms and anxiety, with the association being mediated by pain.

Major finding: Among patients with psoriasis, those with vs without PsA had a higher prevalence of mild depressive symptoms (Hospital Anxiety and Depression Scale [HADS] score ≥8: adjusted odds ratio [aOR] 1.64; P  =  .037) but not severe depressive symptoms (HADS score ≥ 11) and a high prevalence of mild-to-severe anxiety (HADS score ≥ 8: aOR 1.51; P  =  .038 and HADS score ≥ 11; aOR 1.62; P  =  .037). Pain mediated the effect of PsA on depression and anxiety.

Study details: The data of 707 British Association of Dermatologists Biologic and Immunomodulators Register participants (540 with psoriasis and 167 with both psoriasis and PsA) were analyzed.

Disclosures: This study was funded by the UK National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre. Some authors declared serving as speakers or advisory board members, or receiving honoraria, funding, compensation, research grants, or consulting fees from several sources.

Source: Lada G et al. Associations between psoriatic arthritis and mental health among patients with psoriasis: A replication and extension study using the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Skin Health Dis. 2022;e149 (Jul 6). Doi: 10.1002/ski2.149

Key clinical point: Patients with concomitant psoriasis and psoriatic arthritis (PsA) vs only psoriasis were more likely to experience mild depressive symptoms and anxiety, with the association being mediated by pain.

Major finding: Among patients with psoriasis, those with vs without PsA had a higher prevalence of mild depressive symptoms (Hospital Anxiety and Depression Scale [HADS] score ≥8: adjusted odds ratio [aOR] 1.64; P  =  .037) but not severe depressive symptoms (HADS score ≥ 11) and a high prevalence of mild-to-severe anxiety (HADS score ≥ 8: aOR 1.51; P  =  .038 and HADS score ≥ 11; aOR 1.62; P  =  .037). Pain mediated the effect of PsA on depression and anxiety.

Study details: The data of 707 British Association of Dermatologists Biologic and Immunomodulators Register participants (540 with psoriasis and 167 with both psoriasis and PsA) were analyzed.

Disclosures: This study was funded by the UK National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre. Some authors declared serving as speakers or advisory board members, or receiving honoraria, funding, compensation, research grants, or consulting fees from several sources.

Source: Lada G et al. Associations between psoriatic arthritis and mental health among patients with psoriasis: A replication and extension study using the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Skin Health Dis. 2022;e149 (Jul 6). Doi: 10.1002/ski2.149

Key clinical point: Patients with concomitant psoriasis and psoriatic arthritis (PsA) vs only psoriasis were more likely to experience mild depressive symptoms and anxiety, with the association being mediated by pain.

Major finding: Among patients with psoriasis, those with vs without PsA had a higher prevalence of mild depressive symptoms (Hospital Anxiety and Depression Scale [HADS] score ≥8: adjusted odds ratio [aOR] 1.64; P  =  .037) but not severe depressive symptoms (HADS score ≥ 11) and a high prevalence of mild-to-severe anxiety (HADS score ≥ 8: aOR 1.51; P  =  .038 and HADS score ≥ 11; aOR 1.62; P  =  .037). Pain mediated the effect of PsA on depression and anxiety.

Study details: The data of 707 British Association of Dermatologists Biologic and Immunomodulators Register participants (540 with psoriasis and 167 with both psoriasis and PsA) were analyzed.

Disclosures: This study was funded by the UK National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre. Some authors declared serving as speakers or advisory board members, or receiving honoraria, funding, compensation, research grants, or consulting fees from several sources.

Source: Lada G et al. Associations between psoriatic arthritis and mental health among patients with psoriasis: A replication and extension study using the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Skin Health Dis. 2022;e149 (Jul 6). Doi: 10.1002/ski2.149

Key clinical point: In patients with psoriatic arthritis (PsA), early onset psoriasis (EOP) was linked to dactylitis and more frequent use of anti-interleukin 17 (anti-IL17) drugs, whereas late onset psoriasis (LOP) was associated with a higher use of nonsteroidal anti-inflammatory drugs (NSAID) and conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

Major finding: Patients in the EOP vs LOP group had a 9 times higher probability of dactylitis (odds ratio [OR] 9.64; P < .001) and reported a higher use of anti-IL17 drugs (26.8% vs 13.5%; P  =  .039); meanwhile, in the LOP vs EOP group, the use of NSAID (29.7% vs 12.2%; P  =  .016) and csDMARD (21.6% vs 7.3%; P < .01) was more frequent.

Study details: The data come from a cross-sectional analysis of a longitudinal cohort including 160 patients with PsA, of which 84 had EOP (0-40 years) and 76 patients had LOP (>40 years).

Disclosures: This study did not receive any funding or sponsorship. The authors declared no conflicts of interest.

Source: Scriffignano S et al. Dactylitis and early onset psoriasis in psoriatic arthritis: Are they markers of disease severity? A clinical study. Rheumatol Ther. 2022 (Jun 17). Doi: 10.1007/s40744-022-00468-3

Key clinical point: In patients with psoriatic arthritis (PsA), early onset psoriasis (EOP) was linked to dactylitis and more frequent use of anti-interleukin 17 (anti-IL17) drugs, whereas late onset psoriasis (LOP) was associated with a higher use of nonsteroidal anti-inflammatory drugs (NSAID) and conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

Major finding: Patients in the EOP vs LOP group had a 9 times higher probability of dactylitis (odds ratio [OR] 9.64; P < .001) and reported a higher use of anti-IL17 drugs (26.8% vs 13.5%; P  =  .039); meanwhile, in the LOP vs EOP group, the use of NSAID (29.7% vs 12.2%; P  =  .016) and csDMARD (21.6% vs 7.3%; P < .01) was more frequent.

Study details: The data come from a cross-sectional analysis of a longitudinal cohort including 160 patients with PsA, of which 84 had EOP (0-40 years) and 76 patients had LOP (>40 years).

Disclosures: This study did not receive any funding or sponsorship. The authors declared no conflicts of interest.

Source: Scriffignano S et al. Dactylitis and early onset psoriasis in psoriatic arthritis: Are they markers of disease severity? A clinical study. Rheumatol Ther. 2022 (Jun 17). Doi: 10.1007/s40744-022-00468-3

Key clinical point: In patients with psoriatic arthritis (PsA), early onset psoriasis (EOP) was linked to dactylitis and more frequent use of anti-interleukin 17 (anti-IL17) drugs, whereas late onset psoriasis (LOP) was associated with a higher use of nonsteroidal anti-inflammatory drugs (NSAID) and conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

Major finding: Patients in the EOP vs LOP group had a 9 times higher probability of dactylitis (odds ratio [OR] 9.64; P < .001) and reported a higher use of anti-IL17 drugs (26.8% vs 13.5%; P  =  .039); meanwhile, in the LOP vs EOP group, the use of NSAID (29.7% vs 12.2%; P  =  .016) and csDMARD (21.6% vs 7.3%; P < .01) was more frequent.

Study details: The data come from a cross-sectional analysis of a longitudinal cohort including 160 patients with PsA, of which 84 had EOP (0-40 years) and 76 patients had LOP (>40 years).

Disclosures: This study did not receive any funding or sponsorship. The authors declared no conflicts of interest.

Source: Scriffignano S et al. Dactylitis and early onset psoriasis in psoriatic arthritis: Are they markers of disease severity? A clinical study. Rheumatol Ther. 2022 (Jun 17). Doi: 10.1007/s40744-022-00468-3

Key clinical point: Systemic-therapy-naive patients with psoriatic arthritis (PsA) treated with apremilast required a longer time and were less likely to initiate biologic therapy than those treated with methotrexate in the real world.

Major finding: Patients receiving apremilast vs methotrexate had a significantly longer mean time to biologic initiation (194.1 vs 138.7 days; P < .001) and were 58% less likely to use any biologics at 1-year follow-up (odds ratio [OR] 0.42; P < .001), with the likelihood of biologic use being consistently low at 2-year follow-up (OR 0.46; P < .001).

Study details: Findings are from a retrospective, observational, cohort study including 2116 systemic-therapy-naive patients with PsA who initiated apremilast (n = 534) or methotrexate (n = 1582) before initiating biologics.

Disclosures: This study was funded by Amgen Inc. Eight authors reported owning stocks or being current or former employees of Amgen or a company contracted by Amgen.

Source: Husni ME et al. biologic initiation rate in systemic-naïve psoriatic arthritis patients starting treatment with apremilast vs methotrexate: 1-year retrospective analysis of a US claims database. Open Access Rheumatol. 2022;14:123-132 (Jun 15). Doi: 10.2147/OARRR.S342123

Key clinical point: Systemic-therapy-naive patients with psoriatic arthritis (PsA) treated with apremilast required a longer time and were less likely to initiate biologic therapy than those treated with methotrexate in the real world.

Major finding: Patients receiving apremilast vs methotrexate had a significantly longer mean time to biologic initiation (194.1 vs 138.7 days; P < .001) and were 58% less likely to use any biologics at 1-year follow-up (odds ratio [OR] 0.42; P < .001), with the likelihood of biologic use being consistently low at 2-year follow-up (OR 0.46; P < .001).

Study details: Findings are from a retrospective, observational, cohort study including 2116 systemic-therapy-naive patients with PsA who initiated apremilast (n = 534) or methotrexate (n = 1582) before initiating biologics.

Disclosures: This study was funded by Amgen Inc. Eight authors reported owning stocks or being current or former employees of Amgen or a company contracted by Amgen.

Source: Husni ME et al. biologic initiation rate in systemic-naïve psoriatic arthritis patients starting treatment with apremilast vs methotrexate: 1-year retrospective analysis of a US claims database. Open Access Rheumatol. 2022;14:123-132 (Jun 15). Doi: 10.2147/OARRR.S342123

Key clinical point: Systemic-therapy-naive patients with psoriatic arthritis (PsA) treated with apremilast required a longer time and were less likely to initiate biologic therapy than those treated with methotrexate in the real world.

Major finding: Patients receiving apremilast vs methotrexate had a significantly longer mean time to biologic initiation (194.1 vs 138.7 days; P < .001) and were 58% less likely to use any biologics at 1-year follow-up (odds ratio [OR] 0.42; P < .001), with the likelihood of biologic use being consistently low at 2-year follow-up (OR 0.46; P < .001).

Study details: Findings are from a retrospective, observational, cohort study including 2116 systemic-therapy-naive patients with PsA who initiated apremilast (n = 534) or methotrexate (n = 1582) before initiating biologics.

Disclosures: This study was funded by Amgen Inc. Eight authors reported owning stocks or being current or former employees of Amgen or a company contracted by Amgen.

Source: Husni ME et al. biologic initiation rate in systemic-naïve psoriatic arthritis patients starting treatment with apremilast vs methotrexate: 1-year retrospective analysis of a US claims database. Open Access Rheumatol. 2022;14:123-132 (Jun 15). Doi: 10.2147/OARRR.S342123

Key clinical point: Secukinumab demonstrated high retention rates, sustained efficacy, and a favorable safety profile for at least 2 years after initiation in a real-world population of patients with moderate-to-severe psoriatic arthritis (PsA).

Major finding: Secukinumab showed high retention rates (74.9%) at > 2 years after initiation and a sustained improvement in the mean tender joint count (6.3 and 5.6, respectively) and swollen joint count (3.3 and 2.9, respectively) scores at baseline and 2 years. At least 1 serious adverse event was reported by 8.3% of patients, but no death was reported.

Study details: Findings are from a 2-year interim analysis of SERENA, an ongoing, longitudinal, observational study, including 1004 patients with moderate-to-severe PsA (n = 534) or ankylosing spondylitis (n = 470) who received secukinumab for 16 weeks prior recruitment.

Disclosures: This study was funded by Novartis Pharma AG. Three authors reported being employees or owning stocks in Novartis. Several authors reported receiving research grants, consulting fees, or speaker fees from various sources, including Novartis.

Source: Kiltz U et al. Interim 2-year analysis from SERENA: A real-world study in patients with psoriatic arthritis or ankylosing spondylitis treated with secukinumab. Rheumatol Ther. 2022 (Jun 8). Doi: 10.1007/s40744-022-00460-x

Key clinical point: Secukinumab demonstrated high retention rates, sustained efficacy, and a favorable safety profile for at least 2 years after initiation in a real-world population of patients with moderate-to-severe psoriatic arthritis (PsA).

Major finding: Secukinumab showed high retention rates (74.9%) at > 2 years after initiation and a sustained improvement in the mean tender joint count (6.3 and 5.6, respectively) and swollen joint count (3.3 and 2.9, respectively) scores at baseline and 2 years. At least 1 serious adverse event was reported by 8.3% of patients, but no death was reported.

Study details: Findings are from a 2-year interim analysis of SERENA, an ongoing, longitudinal, observational study, including 1004 patients with moderate-to-severe PsA (n = 534) or ankylosing spondylitis (n = 470) who received secukinumab for 16 weeks prior recruitment.

Disclosures: This study was funded by Novartis Pharma AG. Three authors reported being employees or owning stocks in Novartis. Several authors reported receiving research grants, consulting fees, or speaker fees from various sources, including Novartis.

Source: Kiltz U et al. Interim 2-year analysis from SERENA: A real-world study in patients with psoriatic arthritis or ankylosing spondylitis treated with secukinumab. Rheumatol Ther. 2022 (Jun 8). Doi: 10.1007/s40744-022-00460-x

Key clinical point: Secukinumab demonstrated high retention rates, sustained efficacy, and a favorable safety profile for at least 2 years after initiation in a real-world population of patients with moderate-to-severe psoriatic arthritis (PsA).

Major finding: Secukinumab showed high retention rates (74.9%) at > 2 years after initiation and a sustained improvement in the mean tender joint count (6.3 and 5.6, respectively) and swollen joint count (3.3 and 2.9, respectively) scores at baseline and 2 years. At least 1 serious adverse event was reported by 8.3% of patients, but no death was reported.

Study details: Findings are from a 2-year interim analysis of SERENA, an ongoing, longitudinal, observational study, including 1004 patients with moderate-to-severe PsA (n = 534) or ankylosing spondylitis (n = 470) who received secukinumab for 16 weeks prior recruitment.

Disclosures: This study was funded by Novartis Pharma AG. Three authors reported being employees or owning stocks in Novartis. Several authors reported receiving research grants, consulting fees, or speaker fees from various sources, including Novartis.

Source: Kiltz U et al. Interim 2-year analysis from SERENA: A real-world study in patients with psoriatic arthritis or ankylosing spondylitis treated with secukinumab. Rheumatol Ther. 2022 (Jun 8). Doi: 10.1007/s40744-022-00460-x

Key clinical point: Patients with psoriatic arthritis (PsA) who received 100 mg guselkumab once every 4 or 8 weeks (Q4W/Q8W) achieved clinically meaningful improvements through 1 year in several domains of the Patient-Reported Outcomes Measurement Information System.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W achieved ≥ 5-point improvement in fatigue and sleep disturbance (both P < .05) and in pain interference, physical function, social participation, and pain intensity (all P < .001) compared to patients receiving a placebo. A ≥ 5-point improvement in anxiety (P < .05) and depression (P < .01) was achieved by more patients receiving guselkumab Q8W compared to placebo. The improvements were maintained till week 52.

Study details: The findings are from the phase 3 DISCOVER 1 study including 381 patients with active PsA and an inadequate response or tolerance to standard treatments. The patients were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Seven authors declared being employees of Janssen and stockholders of Johnson and Johnson, the parent company of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Orbai AM et al. Meaningful improvement in general health outcomes with guselkumab treatment for psoriatic arthritis: Patient-reported outcomes measurement information system-29 results from a phase 3 study. Patient. 2022 (Jun 30). Doi: 10.1007/s40271-022-00588-6

Key clinical point: Patients with psoriatic arthritis (PsA) who received 100 mg guselkumab once every 4 or 8 weeks (Q4W/Q8W) achieved clinically meaningful improvements through 1 year in several domains of the Patient-Reported Outcomes Measurement Information System.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W achieved ≥ 5-point improvement in fatigue and sleep disturbance (both P < .05) and in pain interference, physical function, social participation, and pain intensity (all P < .001) compared to patients receiving a placebo. A ≥ 5-point improvement in anxiety (P < .05) and depression (P < .01) was achieved by more patients receiving guselkumab Q8W compared to placebo. The improvements were maintained till week 52.

Study details: The findings are from the phase 3 DISCOVER 1 study including 381 patients with active PsA and an inadequate response or tolerance to standard treatments. The patients were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Seven authors declared being employees of Janssen and stockholders of Johnson and Johnson, the parent company of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Orbai AM et al. Meaningful improvement in general health outcomes with guselkumab treatment for psoriatic arthritis: Patient-reported outcomes measurement information system-29 results from a phase 3 study. Patient. 2022 (Jun 30). Doi: 10.1007/s40271-022-00588-6

Key clinical point: Patients with psoriatic arthritis (PsA) who received 100 mg guselkumab once every 4 or 8 weeks (Q4W/Q8W) achieved clinically meaningful improvements through 1 year in several domains of the Patient-Reported Outcomes Measurement Information System.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W achieved ≥ 5-point improvement in fatigue and sleep disturbance (both P < .05) and in pain interference, physical function, social participation, and pain intensity (all P < .001) compared to patients receiving a placebo. A ≥ 5-point improvement in anxiety (P < .05) and depression (P < .01) was achieved by more patients receiving guselkumab Q8W compared to placebo. The improvements were maintained till week 52.

Study details: The findings are from the phase 3 DISCOVER 1 study including 381 patients with active PsA and an inadequate response or tolerance to standard treatments. The patients were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Seven authors declared being employees of Janssen and stockholders of Johnson and Johnson, the parent company of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Orbai AM et al. Meaningful improvement in general health outcomes with guselkumab treatment for psoriatic arthritis: Patient-reported outcomes measurement information system-29 results from a phase 3 study. Patient. 2022 (Jun 30). Doi: 10.1007/s40271-022-00588-6