Key clinical point: Vitamin D concentration at birth was not associated with the risk of developing rheumatoid arthritis (RA) in early adulthood.

Major finding: The risk of developing RA in individuals aged 18-33.9 years was not significantly different among those in the highest vs. lowest vitamin D quintile (adjusted hazard ratio 1.21; 95% CI 0.90-1.63).

Study details: This was a registry-based case-cohort study involving 805 patients with RA with onset in early adulthood and 2,416 individuals from a random subcohort.

Disclosures: This research was supported by the Danish Rheumatism Association and others. The authors declared no conflicts of interest.

Source: Cardoso I et al. Nutrients. 2022;14(3):447 (Jan 20). Doi: 10.3390/nu14030447

Key clinical point: Vitamin D concentration at birth was not associated with the risk of developing rheumatoid arthritis (RA) in early adulthood.

Major finding: The risk of developing RA in individuals aged 18-33.9 years was not significantly different among those in the highest vs. lowest vitamin D quintile (adjusted hazard ratio 1.21; 95% CI 0.90-1.63).

Study details: This was a registry-based case-cohort study involving 805 patients with RA with onset in early adulthood and 2,416 individuals from a random subcohort.

Disclosures: This research was supported by the Danish Rheumatism Association and others. The authors declared no conflicts of interest.

Source: Cardoso I et al. Nutrients. 2022;14(3):447 (Jan 20). Doi: 10.3390/nu14030447

Key clinical point: Vitamin D concentration at birth was not associated with the risk of developing rheumatoid arthritis (RA) in early adulthood.

Major finding: The risk of developing RA in individuals aged 18-33.9 years was not significantly different among those in the highest vs. lowest vitamin D quintile (adjusted hazard ratio 1.21; 95% CI 0.90-1.63).

Study details: This was a registry-based case-cohort study involving 805 patients with RA with onset in early adulthood and 2,416 individuals from a random subcohort.

Disclosures: This research was supported by the Danish Rheumatism Association and others. The authors declared no conflicts of interest.

Source: Cardoso I et al. Nutrients. 2022;14(3):447 (Jan 20). Doi: 10.3390/nu14030447

Key clinical point: In patients with rheumatoid arthritis (RA), low cumulative disease activity was associated with an increased femoral neck bone mineral density (BMD), irrespective of established osteoporosis risk factors.

Major finding: Low cumulative disease activity as measured by Disease Activity Score in 28 Joints with erythrocyte sedimentation rate was independently associated with higher femoral neck BMD compared with moderate/high disease activity (β 0.071; P = .020).

Study details: The findings come from an observational cohort study involving 161 patients with RA.

Disclosures: This study was funded by the Rheumatology Research Foundation Scientist Development Award, National Institute of Aging, and others. The authors declared no conflicts of interest.

Source: Wysham KD et al. Semin Arthritis Rheum. 2022;53:151972 (Jan 31). Doi:  10.1016/j.semarthrit.2022.151972

Key clinical point: In patients with rheumatoid arthritis (RA), low cumulative disease activity was associated with an increased femoral neck bone mineral density (BMD), irrespective of established osteoporosis risk factors.

Major finding: Low cumulative disease activity as measured by Disease Activity Score in 28 Joints with erythrocyte sedimentation rate was independently associated with higher femoral neck BMD compared with moderate/high disease activity (β 0.071; P = .020).

Study details: The findings come from an observational cohort study involving 161 patients with RA.

Disclosures: This study was funded by the Rheumatology Research Foundation Scientist Development Award, National Institute of Aging, and others. The authors declared no conflicts of interest.

Source: Wysham KD et al. Semin Arthritis Rheum. 2022;53:151972 (Jan 31). Doi:  10.1016/j.semarthrit.2022.151972

Key clinical point: In patients with rheumatoid arthritis (RA), low cumulative disease activity was associated with an increased femoral neck bone mineral density (BMD), irrespective of established osteoporosis risk factors.

Major finding: Low cumulative disease activity as measured by Disease Activity Score in 28 Joints with erythrocyte sedimentation rate was independently associated with higher femoral neck BMD compared with moderate/high disease activity (β 0.071; P = .020).

Study details: The findings come from an observational cohort study involving 161 patients with RA.

Disclosures: This study was funded by the Rheumatology Research Foundation Scientist Development Award, National Institute of Aging, and others. The authors declared no conflicts of interest.

Source: Wysham KD et al. Semin Arthritis Rheum. 2022;53:151972 (Jan 31). Doi:  10.1016/j.semarthrit.2022.151972

Key clinical point: The use of disease-modifying antirheumatic drugs (DMARD) or corticosteroids did not affect the risk for Parkinson's disease (PD) in patients with rheumatoid arthritis (RA), except for chloroquine/hydroxychloroquine, which may be potentially associated with a reduced PD risk.

Major finding: At 3 years, the use of DMARDs or corticosteroids was not associated with the risk for PD, except for chloroquine/hydroxychloroquine, which was associated with a decreased risk  (adjusted odds ratio 0.74; 95% CI 0.56-0.97).

Study details: The findings come from the nested nationwide, case-control study including 315 cases with RA diagnosed at least 3 years before the diagnosis of PD. Cases were matched to 1,571 control participants without PD but with RA.

Disclosures: The study was funded by the Michael J. Fox Foundation for Parkinson's Research. The authors declared no conflicts of interest.

Source: Paakinaho A et al. Neurology. 2022 (Jan 21). Doi: 10.1212/WNL.0000000000013303

Key clinical point: The use of disease-modifying antirheumatic drugs (DMARD) or corticosteroids did not affect the risk for Parkinson's disease (PD) in patients with rheumatoid arthritis (RA), except for chloroquine/hydroxychloroquine, which may be potentially associated with a reduced PD risk.

Major finding: At 3 years, the use of DMARDs or corticosteroids was not associated with the risk for PD, except for chloroquine/hydroxychloroquine, which was associated with a decreased risk  (adjusted odds ratio 0.74; 95% CI 0.56-0.97).

Study details: The findings come from the nested nationwide, case-control study including 315 cases with RA diagnosed at least 3 years before the diagnosis of PD. Cases were matched to 1,571 control participants without PD but with RA.

Disclosures: The study was funded by the Michael J. Fox Foundation for Parkinson's Research. The authors declared no conflicts of interest.

Source: Paakinaho A et al. Neurology. 2022 (Jan 21). Doi: 10.1212/WNL.0000000000013303

Key clinical point: The use of disease-modifying antirheumatic drugs (DMARD) or corticosteroids did not affect the risk for Parkinson's disease (PD) in patients with rheumatoid arthritis (RA), except for chloroquine/hydroxychloroquine, which may be potentially associated with a reduced PD risk.

Major finding: At 3 years, the use of DMARDs or corticosteroids was not associated with the risk for PD, except for chloroquine/hydroxychloroquine, which was associated with a decreased risk  (adjusted odds ratio 0.74; 95% CI 0.56-0.97).

Study details: The findings come from the nested nationwide, case-control study including 315 cases with RA diagnosed at least 3 years before the diagnosis of PD. Cases were matched to 1,571 control participants without PD but with RA.

Disclosures: The study was funded by the Michael J. Fox Foundation for Parkinson's Research. The authors declared no conflicts of interest.

Source: Paakinaho A et al. Neurology. 2022 (Jan 21). Doi: 10.1212/WNL.0000000000013303

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.