Key clinical point: A healthy lifestyle was associated with a reduced risk of developing rheumatoid arthritis (RA) overall, as well as for seropositive and seronegative RA.

Major finding: Each unit increase in healthy lifestyle index score was associated with a reduced risk for overall RA (hazard ratio [HR] 0.86; P < .0001), seropositive RA (HR 0.85; P < .0001), and seronegative RA (HR 0.87; P < .001).

Study details: The findings come from an analysis of 2 large prospective cohorts including 107,092 women, among which 1,219 cases of incident RA (seropositive, 776; seronegative, 443) were identified.

Disclosures: The study was supported by the National Institutes of Health and Rheumatology Research Foundation Career Development Bridge Award. The authors declared no conflicts of interest.

Source: Hahn J et al. Arthritis Care Res (Hoboken). 2022 (Jan 18). Doi: 10.1002/acr.24862

Key clinical point: A healthy lifestyle was associated with a reduced risk of developing rheumatoid arthritis (RA) overall, as well as for seropositive and seronegative RA.

Major finding: Each unit increase in healthy lifestyle index score was associated with a reduced risk for overall RA (hazard ratio [HR] 0.86; P < .0001), seropositive RA (HR 0.85; P < .0001), and seronegative RA (HR 0.87; P < .001).

Study details: The findings come from an analysis of 2 large prospective cohorts including 107,092 women, among which 1,219 cases of incident RA (seropositive, 776; seronegative, 443) were identified.

Disclosures: The study was supported by the National Institutes of Health and Rheumatology Research Foundation Career Development Bridge Award. The authors declared no conflicts of interest.

Source: Hahn J et al. Arthritis Care Res (Hoboken). 2022 (Jan 18). Doi: 10.1002/acr.24862

Key clinical point: A healthy lifestyle was associated with a reduced risk of developing rheumatoid arthritis (RA) overall, as well as for seropositive and seronegative RA.

Major finding: Each unit increase in healthy lifestyle index score was associated with a reduced risk for overall RA (hazard ratio [HR] 0.86; P < .0001), seropositive RA (HR 0.85; P < .0001), and seronegative RA (HR 0.87; P < .001).

Study details: The findings come from an analysis of 2 large prospective cohorts including 107,092 women, among which 1,219 cases of incident RA (seropositive, 776; seronegative, 443) were identified.

Disclosures: The study was supported by the National Institutes of Health and Rheumatology Research Foundation Career Development Bridge Award. The authors declared no conflicts of interest.

Source: Hahn J et al. Arthritis Care Res (Hoboken). 2022 (Jan 18). Doi: 10.1002/acr.24862

Key clinical point: Adverse events (AE), most being nonserious, are common within the first year of treatment with methotrexate in patients with early rheumatoid arthritis (RA), with gastrointestinal AEs being most common and women more likely to report AEs compared with men.

Major finding: At least 1 AE within the first year of methotrexate initiation was reported by 77.5% of patients, with gastrointestinal AEs being the most common (42%) and nausea being the most reported single event (31.2%). Women vs. men were more likely to report gastrointestinal AEs (odds ratio 2.03; 95% CI 1.49-2.75).

Study details: The findings come from a prospective cohort of 1,069 patients with RA who initiated methotrexate therapy.

Disclosures: This work was supported by the Versus Arthritis and NIHR Manchester Biomedical Research Centre. All the authors declared no conflicts of interest.

Source: Sherbini AA et al. Rheumatology (Oxford). 2022 (Jan 25). Doi: 10.1093/rheumatology/keab917

Key clinical point: Adverse events (AE), most being nonserious, are common within the first year of treatment with methotrexate in patients with early rheumatoid arthritis (RA), with gastrointestinal AEs being most common and women more likely to report AEs compared with men.

Major finding: At least 1 AE within the first year of methotrexate initiation was reported by 77.5% of patients, with gastrointestinal AEs being the most common (42%) and nausea being the most reported single event (31.2%). Women vs. men were more likely to report gastrointestinal AEs (odds ratio 2.03; 95% CI 1.49-2.75).

Study details: The findings come from a prospective cohort of 1,069 patients with RA who initiated methotrexate therapy.

Disclosures: This work was supported by the Versus Arthritis and NIHR Manchester Biomedical Research Centre. All the authors declared no conflicts of interest.

Source: Sherbini AA et al. Rheumatology (Oxford). 2022 (Jan 25). Doi: 10.1093/rheumatology/keab917

Key clinical point: Adverse events (AE), most being nonserious, are common within the first year of treatment with methotrexate in patients with early rheumatoid arthritis (RA), with gastrointestinal AEs being most common and women more likely to report AEs compared with men.

Major finding: At least 1 AE within the first year of methotrexate initiation was reported by 77.5% of patients, with gastrointestinal AEs being the most common (42%) and nausea being the most reported single event (31.2%). Women vs. men were more likely to report gastrointestinal AEs (odds ratio 2.03; 95% CI 1.49-2.75).

Study details: The findings come from a prospective cohort of 1,069 patients with RA who initiated methotrexate therapy.

Disclosures: This work was supported by the Versus Arthritis and NIHR Manchester Biomedical Research Centre. All the authors declared no conflicts of interest.

Source: Sherbini AA et al. Rheumatology (Oxford). 2022 (Jan 25). Doi: 10.1093/rheumatology/keab917

Key clinical point: Under real-world settings, tofacitinib was not associated with a higher risk for cardiovascular (CV) outcomes compared with tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA); however, the risk could not be ruled out in patients with prior CV disease.

Major finding: Tofacitinib vs. TNFi was not linked with a higher risk for composite CV outcome (pooled weighted hazard ratio [pwHR] 1.01; 95% CI 0.83-1.23); however, the pwHR for patients with and without prior CV disease was 1.27 (95% CI, 0.95-1.70) and 0.81 (95% CI 0.61-1.07), respectively.

Study details: STAR-RA is a multidatabase, population-based study including 1,02,263 patients with RA who initiated treatment with tofacitinib or TNFi.

Disclosures: This study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital & Harvard Medical School, Boston, MA, USA. RJ Desai and SC Kim reported receiving research grants from various sources. All the other authors reported no conflicts of interest.

Source: Khosrow-Khavar F et al. Ann Rheum Dis. 2022 (Jan 13). Doi: 10.1136/annrheumdis-2021-221915

Key clinical point: Under real-world settings, tofacitinib was not associated with a higher risk for cardiovascular (CV) outcomes compared with tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA); however, the risk could not be ruled out in patients with prior CV disease.

Major finding: Tofacitinib vs. TNFi was not linked with a higher risk for composite CV outcome (pooled weighted hazard ratio [pwHR] 1.01; 95% CI 0.83-1.23); however, the pwHR for patients with and without prior CV disease was 1.27 (95% CI, 0.95-1.70) and 0.81 (95% CI 0.61-1.07), respectively.

Study details: STAR-RA is a multidatabase, population-based study including 1,02,263 patients with RA who initiated treatment with tofacitinib or TNFi.

Disclosures: This study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital & Harvard Medical School, Boston, MA, USA. RJ Desai and SC Kim reported receiving research grants from various sources. All the other authors reported no conflicts of interest.

Source: Khosrow-Khavar F et al. Ann Rheum Dis. 2022 (Jan 13). Doi: 10.1136/annrheumdis-2021-221915

Key clinical point: Under real-world settings, tofacitinib was not associated with a higher risk for cardiovascular (CV) outcomes compared with tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA); however, the risk could not be ruled out in patients with prior CV disease.

Major finding: Tofacitinib vs. TNFi was not linked with a higher risk for composite CV outcome (pooled weighted hazard ratio [pwHR] 1.01; 95% CI 0.83-1.23); however, the pwHR for patients with and without prior CV disease was 1.27 (95% CI, 0.95-1.70) and 0.81 (95% CI 0.61-1.07), respectively.

Study details: STAR-RA is a multidatabase, population-based study including 1,02,263 patients with RA who initiated treatment with tofacitinib or TNFi.

Disclosures: This study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital & Harvard Medical School, Boston, MA, USA. RJ Desai and SC Kim reported receiving research grants from various sources. All the other authors reported no conflicts of interest.

Source: Khosrow-Khavar F et al. Ann Rheum Dis. 2022 (Jan 13). Doi: 10.1136/annrheumdis-2021-221915

Key clinical point: Almost one-third of patients with rheumatoid arthritis (RA)-associated interstitial lung disease (ILD) experience acute exacerbation (AE), which significantly affects overall survival.

Major finding: Overall, AE was experienced by 28.1% of patients with RA-ILD, with the 5-year cumulative incidence being 29.4%. The occurrence of AE was significantly associated with a higher risk for mortality (adjusted hazard ratio 2.423; P < .001).

Study details: The findings come from a retrospective analysis involving 310 patients with RA-ILD.

Disclosures: This study was supported by a grant from the Basic Science Research Program through the National Research Foundation of Korea, funded by the Ministry of Science and Technology. All the authors declared no conflicts of interest.

Source: Kwon BS et al. Chest. 2022 (Jan 11). Doi: 10.1016/j.chest.2022.01.007

Key clinical point: Almost one-third of patients with rheumatoid arthritis (RA)-associated interstitial lung disease (ILD) experience acute exacerbation (AE), which significantly affects overall survival.

Major finding: Overall, AE was experienced by 28.1% of patients with RA-ILD, with the 5-year cumulative incidence being 29.4%. The occurrence of AE was significantly associated with a higher risk for mortality (adjusted hazard ratio 2.423; P < .001).

Study details: The findings come from a retrospective analysis involving 310 patients with RA-ILD.

Disclosures: This study was supported by a grant from the Basic Science Research Program through the National Research Foundation of Korea, funded by the Ministry of Science and Technology. All the authors declared no conflicts of interest.

Source: Kwon BS et al. Chest. 2022 (Jan 11). Doi: 10.1016/j.chest.2022.01.007

Key clinical point: Almost one-third of patients with rheumatoid arthritis (RA)-associated interstitial lung disease (ILD) experience acute exacerbation (AE), which significantly affects overall survival.

Major finding: Overall, AE was experienced by 28.1% of patients with RA-ILD, with the 5-year cumulative incidence being 29.4%. The occurrence of AE was significantly associated with a higher risk for mortality (adjusted hazard ratio 2.423; P < .001).

Study details: The findings come from a retrospective analysis involving 310 patients with RA-ILD.

Disclosures: This study was supported by a grant from the Basic Science Research Program through the National Research Foundation of Korea, funded by the Ministry of Science and Technology. All the authors declared no conflicts of interest.

Source: Kwon BS et al. Chest. 2022 (Jan 11). Doi: 10.1016/j.chest.2022.01.007

Key clinical point: Retreatment with a lower rituximab dose of 200 mg or 500 mg was as effective as 1000 mg in patients with rheumatoid arthritis (RA) who responded well to standard rituximab dose.

Major finding: Treatment response was not maintained in 11%, 21%, and 13% of patients in the 1000 mg, 500 mg, and 200 mg rituximab groups, respectively. Ultra-low rituximab dosage was not associated with the presence of antidrug antibodies at 6 months, and B-cell counts were not significantly different between the dosing groups.

Study details: The data comes from a preplanned secondary analysis of the REDO trial involving 140 patients with RA who responded well to the standard rituximab dose for at least 6 months and were randomly assigned to receive 200 mg, 500 mg, or 1000 mg rituximab.

Disclosures: The REDO study was funded by health insurance companies Centraal Ziekenfonds and Menzis, and this secondary analysis did not receive any external funding. The Sint Maartenskliniek (employer of 6 authors) has a patent application filed for rituximab in the treatment of polymyalgia rheumatica.

Source: Wientjes MHM et al. Rheumatology (Oxford). 2022 (Jan 12). Doi: 10.1093/rheumatology/keac024

Key clinical point: Retreatment with a lower rituximab dose of 200 mg or 500 mg was as effective as 1000 mg in patients with rheumatoid arthritis (RA) who responded well to standard rituximab dose.

Major finding: Treatment response was not maintained in 11%, 21%, and 13% of patients in the 1000 mg, 500 mg, and 200 mg rituximab groups, respectively. Ultra-low rituximab dosage was not associated with the presence of antidrug antibodies at 6 months, and B-cell counts were not significantly different between the dosing groups.

Study details: The data comes from a preplanned secondary analysis of the REDO trial involving 140 patients with RA who responded well to the standard rituximab dose for at least 6 months and were randomly assigned to receive 200 mg, 500 mg, or 1000 mg rituximab.

Disclosures: The REDO study was funded by health insurance companies Centraal Ziekenfonds and Menzis, and this secondary analysis did not receive any external funding. The Sint Maartenskliniek (employer of 6 authors) has a patent application filed for rituximab in the treatment of polymyalgia rheumatica.

Source: Wientjes MHM et al. Rheumatology (Oxford). 2022 (Jan 12). Doi: 10.1093/rheumatology/keac024

Key clinical point: Retreatment with a lower rituximab dose of 200 mg or 500 mg was as effective as 1000 mg in patients with rheumatoid arthritis (RA) who responded well to standard rituximab dose.

Major finding: Treatment response was not maintained in 11%, 21%, and 13% of patients in the 1000 mg, 500 mg, and 200 mg rituximab groups, respectively. Ultra-low rituximab dosage was not associated with the presence of antidrug antibodies at 6 months, and B-cell counts were not significantly different between the dosing groups.

Study details: The data comes from a preplanned secondary analysis of the REDO trial involving 140 patients with RA who responded well to the standard rituximab dose for at least 6 months and were randomly assigned to receive 200 mg, 500 mg, or 1000 mg rituximab.

Disclosures: The REDO study was funded by health insurance companies Centraal Ziekenfonds and Menzis, and this secondary analysis did not receive any external funding. The Sint Maartenskliniek (employer of 6 authors) has a patent application filed for rituximab in the treatment of polymyalgia rheumatica.

Source: Wientjes MHM et al. Rheumatology (Oxford). 2022 (Jan 12). Doi: 10.1093/rheumatology/keac024

Key clinical point: Tofacitinib was associated with a higher risk for major adverse cardiovascular events (MACE) and cancer than tumor necrosis factor (TNF) inhibitors in a cardiovascular risk-enriched population of patients with active rheumatoid arthritis (RA).

Major finding: During a median follow-up of 4 years, the combined tofacitinib doses vs. TNF inhibitors were associated with a higher incidence of MACE (hazard ratio [HR] 1.33; 95% CI 0.91-1.94) and cancer (HR 1.48; 95% CI 1.04-2.09), not meeting the predefined criteria for noninferiority.

Study details: The findings come from the noninferiority, phase 3b-4, safety end-point ORAL Surveillance trial involving 4,362 patients aged 50 years or older with at least 1 additional cardiovascular risk factor who had active RA despite methotrexate treatment. The patients were randomly assigned to 5 mg or 10 mg tofacitinib twice daily or a TNF inhibitor.

Disclosures: This study was funded by Pfizer. Some of the authors declared being employees or holding stocks at Pfizer, whereas some others declared serving as a consultant or receiving grants from various sources.

Source: Ytterberg SR et al. N Engl J Med. 2022;386:316-326 (Jan 27). Doi: 10.1056/NEJMoa2109927

Key clinical point: Tofacitinib was associated with a higher risk for major adverse cardiovascular events (MACE) and cancer than tumor necrosis factor (TNF) inhibitors in a cardiovascular risk-enriched population of patients with active rheumatoid arthritis (RA).

Major finding: During a median follow-up of 4 years, the combined tofacitinib doses vs. TNF inhibitors were associated with a higher incidence of MACE (hazard ratio [HR] 1.33; 95% CI 0.91-1.94) and cancer (HR 1.48; 95% CI 1.04-2.09), not meeting the predefined criteria for noninferiority.

Study details: The findings come from the noninferiority, phase 3b-4, safety end-point ORAL Surveillance trial involving 4,362 patients aged 50 years or older with at least 1 additional cardiovascular risk factor who had active RA despite methotrexate treatment. The patients were randomly assigned to 5 mg or 10 mg tofacitinib twice daily or a TNF inhibitor.

Disclosures: This study was funded by Pfizer. Some of the authors declared being employees or holding stocks at Pfizer, whereas some others declared serving as a consultant or receiving grants from various sources.

Source: Ytterberg SR et al. N Engl J Med. 2022;386:316-326 (Jan 27). Doi: 10.1056/NEJMoa2109927

Key clinical point: Tofacitinib was associated with a higher risk for major adverse cardiovascular events (MACE) and cancer than tumor necrosis factor (TNF) inhibitors in a cardiovascular risk-enriched population of patients with active rheumatoid arthritis (RA).

Major finding: During a median follow-up of 4 years, the combined tofacitinib doses vs. TNF inhibitors were associated with a higher incidence of MACE (hazard ratio [HR] 1.33; 95% CI 0.91-1.94) and cancer (HR 1.48; 95% CI 1.04-2.09), not meeting the predefined criteria for noninferiority.

Study details: The findings come from the noninferiority, phase 3b-4, safety end-point ORAL Surveillance trial involving 4,362 patients aged 50 years or older with at least 1 additional cardiovascular risk factor who had active RA despite methotrexate treatment. The patients were randomly assigned to 5 mg or 10 mg tofacitinib twice daily or a TNF inhibitor.

Disclosures: This study was funded by Pfizer. Some of the authors declared being employees or holding stocks at Pfizer, whereas some others declared serving as a consultant or receiving grants from various sources.

Source: Ytterberg SR et al. N Engl J Med. 2022;386:316-326 (Jan 27). Doi: 10.1056/NEJMoa2109927

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Catholic Medical Center has agreed to pay $3.8 million to settle claims it provided free call coverage to a cardiologist in exchange for patient referrals to the Manchester, N.H., hospital, according to federal officials.

“The cardiologist who received the free call coverage referred millions of dollars in medical procedures and services to CMC over the decade in which the free services were provided,” the Department of Justice said in a news release.

Because the hospital submitted claims for payment to Medicare, Medicaid, and other federal health care programs for the services referred by the cardiologist, the government alleged the claims were the result of unlawful kickbacks.

The settlement resolves allegations brought in a whistleblower lawsuit filed in 2018 by cardiologist David Goldberg, MD, who previously worked at Catholic Medical Center (CMC) and is represented by Douglas, Leonard & Garvey.

The news release did not name the cardiologist involved in the alleged kickback scheme but the recently unsealed lawsuit says CMC paid its cardiologists above market rates ($10,000 per weekend, $3,000 per night) to provide free coverage services for Mary-Claire Paicopolis, MD.

The lawsuit also claims Dr. Paicopolis insisted the hospital implant only Boston Scientific devices in her patients and that her preferred electrophysiologist use only its Rhythmia mapping system during ablation procedures. To keep CMC from objecting, the suit alleges Boston Scientific offered CMC early access to its Watchman left atrial appendage occluder and provided “unprecedented” support to a nonacademic community hospital site.

“It went back several years, and that and the other issues in the suit were strong motivators for Dr. Goldberg to try to rectify the situation and he deserves a lot of credit for having done so,” attorney Charles G. Douglas III told this news organization.

Dr. Goldberg will receive $570,000 of the $3.8 million settlement as well as $145,361 in expenses, attorney fees, and costs.

Although not addressed in the federal news release, the lawsuit also alleges that CMC staff manipulated mortality data by discharging patients from the ICU and then readmitting them to hospice with a new patient number, “thereby avoiding the need to claim a surgical mortality.”

The lawsuit also says CMC “created a practice of covering up medical errors” and detailed 12 patient deaths between 2012 and 2018, alleging that these deaths were the result of substandard care.

CMC spokesperson Lauren Collins-Cline said in an email that the call coverage arrangement is no longer in place and originated almost 15 years ago with the input of legal counsel in order to provide high-quality care for patients.

“While CMC vigorously disagrees with the government’s allegations that this arrangement violated federal law, we have agreed to settle in order to avoid long costly civil litigation,” she said.

As to the other claims in the complaint, Ms. Collins-Cline said they were investigated by the government and dismissed per the settlement agreement. “CMC holds itself to the highest ethical standards in patient care and business conduct. That’s embedded in our mission and will always remain our highest priority.”

Mr. Douglas, however, said the government retains the right to pursue other claims in the lawsuit in the future. “So, [the hospital] is a little more optimistic than the reality of what the government agrees is the situation.”

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

Catholic Medical Center has agreed to pay $3.8 million to settle claims it provided free call coverage to a cardiologist in exchange for patient referrals to the Manchester, N.H., hospital, according to federal officials.

“The cardiologist who received the free call coverage referred millions of dollars in medical procedures and services to CMC over the decade in which the free services were provided,” the Department of Justice said in a news release.

Because the hospital submitted claims for payment to Medicare, Medicaid, and other federal health care programs for the services referred by the cardiologist, the government alleged the claims were the result of unlawful kickbacks.

The settlement resolves allegations brought in a whistleblower lawsuit filed in 2018 by cardiologist David Goldberg, MD, who previously worked at Catholic Medical Center (CMC) and is represented by Douglas, Leonard & Garvey.

The news release did not name the cardiologist involved in the alleged kickback scheme but the recently unsealed lawsuit says CMC paid its cardiologists above market rates ($10,000 per weekend, $3,000 per night) to provide free coverage services for Mary-Claire Paicopolis, MD.

The lawsuit also claims Dr. Paicopolis insisted the hospital implant only Boston Scientific devices in her patients and that her preferred electrophysiologist use only its Rhythmia mapping system during ablation procedures. To keep CMC from objecting, the suit alleges Boston Scientific offered CMC early access to its Watchman left atrial appendage occluder and provided “unprecedented” support to a nonacademic community hospital site.

“It went back several years, and that and the other issues in the suit were strong motivators for Dr. Goldberg to try to rectify the situation and he deserves a lot of credit for having done so,” attorney Charles G. Douglas III told this news organization.

Dr. Goldberg will receive $570,000 of the $3.8 million settlement as well as $145,361 in expenses, attorney fees, and costs.

Although not addressed in the federal news release, the lawsuit also alleges that CMC staff manipulated mortality data by discharging patients from the ICU and then readmitting them to hospice with a new patient number, “thereby avoiding the need to claim a surgical mortality.”

The lawsuit also says CMC “created a practice of covering up medical errors” and detailed 12 patient deaths between 2012 and 2018, alleging that these deaths were the result of substandard care.

CMC spokesperson Lauren Collins-Cline said in an email that the call coverage arrangement is no longer in place and originated almost 15 years ago with the input of legal counsel in order to provide high-quality care for patients.

“While CMC vigorously disagrees with the government’s allegations that this arrangement violated federal law, we have agreed to settle in order to avoid long costly civil litigation,” she said.

As to the other claims in the complaint, Ms. Collins-Cline said they were investigated by the government and dismissed per the settlement agreement. “CMC holds itself to the highest ethical standards in patient care and business conduct. That’s embedded in our mission and will always remain our highest priority.”

Mr. Douglas, however, said the government retains the right to pursue other claims in the lawsuit in the future. “So, [the hospital] is a little more optimistic than the reality of what the government agrees is the situation.”

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

Catholic Medical Center has agreed to pay $3.8 million to settle claims it provided free call coverage to a cardiologist in exchange for patient referrals to the Manchester, N.H., hospital, according to federal officials.

“The cardiologist who received the free call coverage referred millions of dollars in medical procedures and services to CMC over the decade in which the free services were provided,” the Department of Justice said in a news release.

Because the hospital submitted claims for payment to Medicare, Medicaid, and other federal health care programs for the services referred by the cardiologist, the government alleged the claims were the result of unlawful kickbacks.

The settlement resolves allegations brought in a whistleblower lawsuit filed in 2018 by cardiologist David Goldberg, MD, who previously worked at Catholic Medical Center (CMC) and is represented by Douglas, Leonard & Garvey.

The news release did not name the cardiologist involved in the alleged kickback scheme but the recently unsealed lawsuit says CMC paid its cardiologists above market rates ($10,000 per weekend, $3,000 per night) to provide free coverage services for Mary-Claire Paicopolis, MD.

The lawsuit also claims Dr. Paicopolis insisted the hospital implant only Boston Scientific devices in her patients and that her preferred electrophysiologist use only its Rhythmia mapping system during ablation procedures. To keep CMC from objecting, the suit alleges Boston Scientific offered CMC early access to its Watchman left atrial appendage occluder and provided “unprecedented” support to a nonacademic community hospital site.

“It went back several years, and that and the other issues in the suit were strong motivators for Dr. Goldberg to try to rectify the situation and he deserves a lot of credit for having done so,” attorney Charles G. Douglas III told this news organization.

Dr. Goldberg will receive $570,000 of the $3.8 million settlement as well as $145,361 in expenses, attorney fees, and costs.

Although not addressed in the federal news release, the lawsuit also alleges that CMC staff manipulated mortality data by discharging patients from the ICU and then readmitting them to hospice with a new patient number, “thereby avoiding the need to claim a surgical mortality.”

The lawsuit also says CMC “created a practice of covering up medical errors” and detailed 12 patient deaths between 2012 and 2018, alleging that these deaths were the result of substandard care.

CMC spokesperson Lauren Collins-Cline said in an email that the call coverage arrangement is no longer in place and originated almost 15 years ago with the input of legal counsel in order to provide high-quality care for patients.

“While CMC vigorously disagrees with the government’s allegations that this arrangement violated federal law, we have agreed to settle in order to avoid long costly civil litigation,” she said.

As to the other claims in the complaint, Ms. Collins-Cline said they were investigated by the government and dismissed per the settlement agreement. “CMC holds itself to the highest ethical standards in patient care and business conduct. That’s embedded in our mission and will always remain our highest priority.”

Mr. Douglas, however, said the government retains the right to pursue other claims in the lawsuit in the future. “So, [the hospital] is a little more optimistic than the reality of what the government agrees is the situation.”

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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

An infliximab biosimilar (infliximab-axxq) delivered via subcutaneous injection was superior to intravenous vedolizumab (Entyvio) for induction and maintenance therapy of Crohn’s disease (CD), according to a systematic review and meta-analysis from French researchers.  

In contrast, the same research showed no significant differences in efficacy between these agents for people with ulcerative colitis (UC).

The subcutaneous injection formulation of infliximab-axxq, also known as CT-P13 SC, is approved by the European Medicines Agency for both CD and UC (Remsima SC). This formulation is not yet approved by the U.S. Food and Drug Administration.

“It’s kind of a small revolution, because now we have access, and in France, we are using a lot of subcutaneous infliximab,” Laurent Peyrin-Biroulet, MD, said during a digital oral presentation at ECCO ‘22 Virtual, the European Crohn’s and Colitis Organisation 2022 Congress. He is ECCO president and a gastroenterologist at University Hospital of Nancy in France.

Dr. Peyrin-Biroulet and colleagues compared the efficacy and safety of the two agents in major randomized controlled trials looking at moderate-to-severe CD or UC from January 2010 to April 2021.

Subcutaneous infliximab-axxq data came from NCT02883452, an ongoing phase 1 study started in 2016. The vedolizumab data come from GEMINI I, II, and III; VISIBLE 1 and 2; and VARSITY trials.
 

Key findings

In CD, induction efficacy was 79% for subcutaneous infliximab-axxq versus a 45% response for vedolizumab, as measured by the Crohn’s Disease Activity Index-70 (CDAI-70).

In addition, the study showed a 62% induction efficacy for subcutaneous infliximab-axxq versus 36% for vedolizumab on the CDAI-100.

The maintenance response on the CDAI-100 was achieved by 64% of the infliximab-axxq patients versus 47% of the vedolizumab patients.

“You can see better efficacy results of subcutaneous infliximab compared to vedolizumab in CD for both induction and maintenance,” Dr. Peyrin-Biroulet said, adding that what is seen here is probably what has been observed.
 

Similar results for UC

“We know vedolizumab is a good drug in UC, and there was not a difference between UC and CD,” Dr. Peyrin-Biroulet said.

There were no significant differences between subcutaneous infliximab-axxq and vedolizumab in terms of clinical response for induction (77% vs. 69%, respectively) or clinical response for maintenance (62% vs. 63%, respectively).

Similarly, no significant differences emerged in rates of clinical remission or mucosal healing.
 

Safety so far

Safety profiles for both agents in both indications were similar over 1 year.

However, Dr. Peyrin-Biroulet shared a caveat about that timeline. “It’s a 1-year follow-up, not a 10-year follow-up with 100,000 patients,” he said. “But still, what we see here is a confirmation of what we see in other analyses. There is not a significant [safety] difference between these two drugs.”

The rate of any adverse event in CD was 76% for subcutaneous infliximab-axxq versus 77% for vedolizumab, for example. Rates of any serious adverse event were 9% and 14%, respectively.

In UC studies, the rate of any adverse event was 67% for subcutaneous infliximab-axxq versus 64% for vedolizumab. Rates of serious adverse events were 12% and 11%, respectively.

Rates of discontinuation over 1 year differed between agents. Five percent of subcutaneous infliximab-axxq participants with CD discontinued treatment as because of lack of efficacy compared with 32% with vedolizumab. In UC participants, discontinuation for the same reason was reported for 3% of subcutaneous infliximab-axxq patients versus 15% of vedolizumab.

Although all participants in the subcutaneous infliximab-axxq trial were anti-tumor necrosis factor treatment naive, some in the vedolizumab may have been previously exposed to such therapy, Dr. Peyrin-Biroulet said. “Subgroup analyses would be need to further explore that.”

“It’s interesting and a clinically relevant piece of work,” said Mark Samaan, MD, session moderator and consultant gastroenterologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, who was not involved in the study.

“The results are in keeping with what one might expect from IV infliximab administration. In that sense, [it is] reassuring that the two routes of administration appear to perform in a broadly similar manner,” Dr. Samaan said.

“So long as adequate exposure is achieved, I wouldn’t have expected route of administration to be a significant determinant of efficacy,” he added.

Dr. Peyrin-Biroulet reports receiving personal fees from Galapagos, AbbVie, Janssen, Genetech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergen, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgene, Mylan, Lilly, Fresenius Kabi, Opplian Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance. Dr. Samaan reports receiving advisory fees from Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, and AbbVie and lecture fees from Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, and Galapagos.

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