Clinical Edge Journal Scan Commentary: EPI October 2021

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Dr. Goel scans the journals, so you don't have to!

Akash Goel, MD

This month’s journal scan of articles in exocrine pancreatic insufficiency explores the connection between the two functions of the pancreas, both exocrine and endocrine–and demonstrates somewhat differing findings which are worth exploration.

 

The first paper is from Uysal and Argun out of Istanbul, Turkey which explores the connection between insulin resistance and the development of exocrine pancreatic insufficiency (EPI). Researchers enrolled 65 patients with obesity and ages 16-69. The homeostasis model of assessment (HOMA) was used for the diagnosis of insulin resistance, and EPI was diagnosed with a fecal elastase-1 (FE-1) < 200 µg/g (via enzyme-linked immunosorbent assay). The study looked at both mean FE-1 levels as well as the distribution of EPI amongst patients with and without insulin resistance.

 

The study reported FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77 µg/g; P = .119) and the rate of EPI (FE-1 < 200 µg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance. The authors note that prior studies have suggested a link between EPI and diabetes mellitus (DM); however this study shows the correlation may not be strong in the pre-diabetic insulin resistance, or pre-DM period.

 

Further along the diabetes spectrum, researchers in China aimed to assess the prevalence of EPI amongst the type 2 DM (T2DM) Chinese population, and to further identify factors associated with the development of EPI. This study was a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases. Fecal samples were used to measure FE-1 levels, and blood samples were collected to investigate pancreatic endocrine function and metabolic biomarkers in all participants. Multiple logistic regression analysis was used to evaluate the influencing factors of pancreatic exocrine insufficiency in patients with T2DM.

Ultimately, the prevalence of EPI (FE-1 < 200 µg/g) amongst this patient population was 18.8%. There was a highly significant positive association between FE-1 levels and fasting C-peptide (FCP) levels (correlation coefficient 0.451; P < .001). Logistic regression analysis demonstrated that FCP was independently associated with EPI (odds ratio 0.204; P = .024), and receiver operating characteristic (ROC) analysis demonstrated good predictive value for EPI as well.

In summary, the authors infer a mechanistic conclusion that likely merits further investigation, “the reduced quantity and quality of β-cell lead to insufficient insulin secretion and subsequently results in hyperglycemia and DM. Further, as the trophic function from β-cells on pancreatic acinar cells weaken, the development into exocrine dysfunction in patients with DM is likely.”

 

 

Bibliography

  1. Uysal BB, Argun D. Assessment of the impact of insulin resistance on pancreatic exocrine functions in obese patients. Med-Science. 2021;10(3):998-1001.
  2. Lv Y, Wei Q, Yuan X, et al. Two sides of the pancreas: Exocrine insufficiency is correlated with endocrine dysfunction in type 2 diabetes. Clin Chim Acta. 2021(Sep 14);523:81-86. doi: 10.1016/j.cca.2021.09.008.
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Akash Goel, MD

Assistant Professor, Weill Cornell/New York Presbyterian Hospital

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Akash Goel, MD

Assistant Professor, Weill Cornell/New York Presbyterian Hospital

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Akash Goel, MD

Assistant Professor, Weill Cornell/New York Presbyterian Hospital

Dr. Goel scans the journals, so you don't have to!
Dr. Goel scans the journals, so you don't have to!

Akash Goel, MD

This month’s journal scan of articles in exocrine pancreatic insufficiency explores the connection between the two functions of the pancreas, both exocrine and endocrine–and demonstrates somewhat differing findings which are worth exploration.

 

The first paper is from Uysal and Argun out of Istanbul, Turkey which explores the connection between insulin resistance and the development of exocrine pancreatic insufficiency (EPI). Researchers enrolled 65 patients with obesity and ages 16-69. The homeostasis model of assessment (HOMA) was used for the diagnosis of insulin resistance, and EPI was diagnosed with a fecal elastase-1 (FE-1) < 200 µg/g (via enzyme-linked immunosorbent assay). The study looked at both mean FE-1 levels as well as the distribution of EPI amongst patients with and without insulin resistance.

 

The study reported FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77 µg/g; P = .119) and the rate of EPI (FE-1 < 200 µg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance. The authors note that prior studies have suggested a link between EPI and diabetes mellitus (DM); however this study shows the correlation may not be strong in the pre-diabetic insulin resistance, or pre-DM period.

 

Further along the diabetes spectrum, researchers in China aimed to assess the prevalence of EPI amongst the type 2 DM (T2DM) Chinese population, and to further identify factors associated with the development of EPI. This study was a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases. Fecal samples were used to measure FE-1 levels, and blood samples were collected to investigate pancreatic endocrine function and metabolic biomarkers in all participants. Multiple logistic regression analysis was used to evaluate the influencing factors of pancreatic exocrine insufficiency in patients with T2DM.

Ultimately, the prevalence of EPI (FE-1 < 200 µg/g) amongst this patient population was 18.8%. There was a highly significant positive association between FE-1 levels and fasting C-peptide (FCP) levels (correlation coefficient 0.451; P < .001). Logistic regression analysis demonstrated that FCP was independently associated with EPI (odds ratio 0.204; P = .024), and receiver operating characteristic (ROC) analysis demonstrated good predictive value for EPI as well.

In summary, the authors infer a mechanistic conclusion that likely merits further investigation, “the reduced quantity and quality of β-cell lead to insufficient insulin secretion and subsequently results in hyperglycemia and DM. Further, as the trophic function from β-cells on pancreatic acinar cells weaken, the development into exocrine dysfunction in patients with DM is likely.”

 

 

Bibliography

  1. Uysal BB, Argun D. Assessment of the impact of insulin resistance on pancreatic exocrine functions in obese patients. Med-Science. 2021;10(3):998-1001.
  2. Lv Y, Wei Q, Yuan X, et al. Two sides of the pancreas: Exocrine insufficiency is correlated with endocrine dysfunction in type 2 diabetes. Clin Chim Acta. 2021(Sep 14);523:81-86. doi: 10.1016/j.cca.2021.09.008.

Akash Goel, MD

This month’s journal scan of articles in exocrine pancreatic insufficiency explores the connection between the two functions of the pancreas, both exocrine and endocrine–and demonstrates somewhat differing findings which are worth exploration.

 

The first paper is from Uysal and Argun out of Istanbul, Turkey which explores the connection between insulin resistance and the development of exocrine pancreatic insufficiency (EPI). Researchers enrolled 65 patients with obesity and ages 16-69. The homeostasis model of assessment (HOMA) was used for the diagnosis of insulin resistance, and EPI was diagnosed with a fecal elastase-1 (FE-1) < 200 µg/g (via enzyme-linked immunosorbent assay). The study looked at both mean FE-1 levels as well as the distribution of EPI amongst patients with and without insulin resistance.

 

The study reported FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77 µg/g; P = .119) and the rate of EPI (FE-1 < 200 µg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance. The authors note that prior studies have suggested a link between EPI and diabetes mellitus (DM); however this study shows the correlation may not be strong in the pre-diabetic insulin resistance, or pre-DM period.

 

Further along the diabetes spectrum, researchers in China aimed to assess the prevalence of EPI amongst the type 2 DM (T2DM) Chinese population, and to further identify factors associated with the development of EPI. This study was a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases. Fecal samples were used to measure FE-1 levels, and blood samples were collected to investigate pancreatic endocrine function and metabolic biomarkers in all participants. Multiple logistic regression analysis was used to evaluate the influencing factors of pancreatic exocrine insufficiency in patients with T2DM.

Ultimately, the prevalence of EPI (FE-1 < 200 µg/g) amongst this patient population was 18.8%. There was a highly significant positive association between FE-1 levels and fasting C-peptide (FCP) levels (correlation coefficient 0.451; P < .001). Logistic regression analysis demonstrated that FCP was independently associated with EPI (odds ratio 0.204; P = .024), and receiver operating characteristic (ROC) analysis demonstrated good predictive value for EPI as well.

In summary, the authors infer a mechanistic conclusion that likely merits further investigation, “the reduced quantity and quality of β-cell lead to insufficient insulin secretion and subsequently results in hyperglycemia and DM. Further, as the trophic function from β-cells on pancreatic acinar cells weaken, the development into exocrine dysfunction in patients with DM is likely.”

 

 

Bibliography

  1. Uysal BB, Argun D. Assessment of the impact of insulin resistance on pancreatic exocrine functions in obese patients. Med-Science. 2021;10(3):998-1001.
  2. Lv Y, Wei Q, Yuan X, et al. Two sides of the pancreas: Exocrine insufficiency is correlated with endocrine dysfunction in type 2 diabetes. Clin Chim Acta. 2021(Sep 14);523:81-86. doi: 10.1016/j.cca.2021.09.008.
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Clinical Edge Journal Scan Commentary: Contraception October 2021

Article Type
Changed
Dr. McCullough scans the journals, so you don’t have to!

Deanna C. McCullough, MD



 

Contraception prescription patterns vary by specialty and geography

 

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.


 

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  


 

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

 

 

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

 

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

Author and Disclosure Information

Deanna C. McCullough, MD, Assistant Professor; Assistant Residency Program Director, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida
Deanna C. McCullough, MD, has disclosed no relevant financial relationships.

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Deanna C. McCullough, MD, Assistant Professor; Assistant Residency Program Director, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida
Deanna C. McCullough, MD, has disclosed no relevant financial relationships.

Author and Disclosure Information

Deanna C. McCullough, MD, Assistant Professor; Assistant Residency Program Director, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida
Deanna C. McCullough, MD, has disclosed no relevant financial relationships.

Dr. McCullough scans the journals, so you don’t have to!
Dr. McCullough scans the journals, so you don’t have to!

Deanna C. McCullough, MD



 

Contraception prescription patterns vary by specialty and geography

 

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.


 

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  


 

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

 

 

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

 

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

Deanna C. McCullough, MD



 

Contraception prescription patterns vary by specialty and geography

 

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.


 

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  


 

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

 

 

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

 

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

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Clinical Edge Journal Scan Commentary: RA October 2021

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Dr. Jayatilleke scans the journals, so you don't have to!

Arundathi Jayatilleke, MD

Cigarette smoking is a well-known modifiable risk factor for the development of rheumatoid arthritis (RA). Studies have suggested not only an elevated risk but possible pathogenetic role in the development of autoantibodies, as well as effects on disease outcomes. Passive cigarette smoking has also been proposed as a potential risk factor for RA, though studies are harder to evaluate. This review of prospective data from the Nurses Health Study (NHS) by Yoshida et al looks at incident RA among women enrolled in the study and the influence of in utero, childhood, and adulthood exposure to cigarettes. Childhood exposure to parental smoking was associated with seropositive RA (hazard ratio 1.75) even after controlling for adult personal smoking, and maternal smoking during pregnancy was associated with RA, though the latter effect was not seen after controlling for subsequent smoking exposure. As the authors point out, verifiable prospective data is difficult to obtain regarding exposure to smoking in utero or in childhood and recall bias is possible in obtaining historical information in this prospective study given the use of questionnaires, though it remains plausible given prior studies on the association of personal smoking with RA.

 

The involvement of gut microbiota in development of autoimmunity has also been postulated but not well-explained. Several recent studies have examined the impact of antibiotic use on the development of RA, including a recent large UK-based case-control study suggesting an increase in RA incidence in people with antibiotic exposure. While a systematic review is ongoing, this prospective cohort study by Liu et al also examines data from NHSI and NHSII and RA risk in patients exposed to antibiotics, stratified by duration of use (none, ≤14 days, ≥15 days). It is reassuring that in this study neither short term (≤14 days) nor long term (≥15 days) antibiotic use was associated with RA risk. Comparison with prior studies with prescription data, however, is limited given the use of questionnaires to establish duration of recent antibiotic exposure.

 

Fatigue is a common symptom of RA and has a high impact on quality of life in terms of function. The study by Holten et al examines data from the ARCTIC trial in terms of associations between disease activity and fatigue in early RA, as well as change in fatigue with therapy for RA. Fatigue was measured via a visual analog scale (VAS) and did decrease with therapy from baseline; 80% of patients in the study had moderate or high disease activity based on disease activity score (DAS) at baseline and 69% of patients reported fatigue, while 9% of patients had moderate or high disease activity based on DAS at  24 months and 38% reported fatigue. Interestingly, patients who were in remission (per DAS) at 6 months had a reduced risk of fatigue at 24 months. It is hard to interpret this information in a granular way as fatigue is not measured in a standardized way across clinical studies and the only instrument of measure in the ARCTIC trial was the VAS. An alternate view, for example examining the impact of baseline fatigue on response to therapy, may also be reasonable, or fatigue may be a residual symptom similar to chronic myofascial or “non-inflammatory” pain not responsive to treatment in RA.

 

Finally, another associated extra-articular manifestation of RA is bronchiectasis. Martin et al performed a systematic review and meta-analysis of the literature and found that the prevalence of bronchiectasis was about 18% in RA patients, suggesting that it is more common than previously thought. However, inclusion of CT imaging may detect subclinical bronchiectasis and other secondary causes were not determined. Still, given the effects on quality of life and mortality, further research into causes and risk factors for bronchiectasis in RA is warranted.

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Arundathi Jayatilleke, MD
Lewis Katz School of Medicine, Temple University

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Dr. Jayatilleke scans the journals, so you don't have to!
Dr. Jayatilleke scans the journals, so you don't have to!

Arundathi Jayatilleke, MD

Cigarette smoking is a well-known modifiable risk factor for the development of rheumatoid arthritis (RA). Studies have suggested not only an elevated risk but possible pathogenetic role in the development of autoantibodies, as well as effects on disease outcomes. Passive cigarette smoking has also been proposed as a potential risk factor for RA, though studies are harder to evaluate. This review of prospective data from the Nurses Health Study (NHS) by Yoshida et al looks at incident RA among women enrolled in the study and the influence of in utero, childhood, and adulthood exposure to cigarettes. Childhood exposure to parental smoking was associated with seropositive RA (hazard ratio 1.75) even after controlling for adult personal smoking, and maternal smoking during pregnancy was associated with RA, though the latter effect was not seen after controlling for subsequent smoking exposure. As the authors point out, verifiable prospective data is difficult to obtain regarding exposure to smoking in utero or in childhood and recall bias is possible in obtaining historical information in this prospective study given the use of questionnaires, though it remains plausible given prior studies on the association of personal smoking with RA.

 

The involvement of gut microbiota in development of autoimmunity has also been postulated but not well-explained. Several recent studies have examined the impact of antibiotic use on the development of RA, including a recent large UK-based case-control study suggesting an increase in RA incidence in people with antibiotic exposure. While a systematic review is ongoing, this prospective cohort study by Liu et al also examines data from NHSI and NHSII and RA risk in patients exposed to antibiotics, stratified by duration of use (none, ≤14 days, ≥15 days). It is reassuring that in this study neither short term (≤14 days) nor long term (≥15 days) antibiotic use was associated with RA risk. Comparison with prior studies with prescription data, however, is limited given the use of questionnaires to establish duration of recent antibiotic exposure.

 

Fatigue is a common symptom of RA and has a high impact on quality of life in terms of function. The study by Holten et al examines data from the ARCTIC trial in terms of associations between disease activity and fatigue in early RA, as well as change in fatigue with therapy for RA. Fatigue was measured via a visual analog scale (VAS) and did decrease with therapy from baseline; 80% of patients in the study had moderate or high disease activity based on disease activity score (DAS) at baseline and 69% of patients reported fatigue, while 9% of patients had moderate or high disease activity based on DAS at  24 months and 38% reported fatigue. Interestingly, patients who were in remission (per DAS) at 6 months had a reduced risk of fatigue at 24 months. It is hard to interpret this information in a granular way as fatigue is not measured in a standardized way across clinical studies and the only instrument of measure in the ARCTIC trial was the VAS. An alternate view, for example examining the impact of baseline fatigue on response to therapy, may also be reasonable, or fatigue may be a residual symptom similar to chronic myofascial or “non-inflammatory” pain not responsive to treatment in RA.

 

Finally, another associated extra-articular manifestation of RA is bronchiectasis. Martin et al performed a systematic review and meta-analysis of the literature and found that the prevalence of bronchiectasis was about 18% in RA patients, suggesting that it is more common than previously thought. However, inclusion of CT imaging may detect subclinical bronchiectasis and other secondary causes were not determined. Still, given the effects on quality of life and mortality, further research into causes and risk factors for bronchiectasis in RA is warranted.

Arundathi Jayatilleke, MD

Cigarette smoking is a well-known modifiable risk factor for the development of rheumatoid arthritis (RA). Studies have suggested not only an elevated risk but possible pathogenetic role in the development of autoantibodies, as well as effects on disease outcomes. Passive cigarette smoking has also been proposed as a potential risk factor for RA, though studies are harder to evaluate. This review of prospective data from the Nurses Health Study (NHS) by Yoshida et al looks at incident RA among women enrolled in the study and the influence of in utero, childhood, and adulthood exposure to cigarettes. Childhood exposure to parental smoking was associated with seropositive RA (hazard ratio 1.75) even after controlling for adult personal smoking, and maternal smoking during pregnancy was associated with RA, though the latter effect was not seen after controlling for subsequent smoking exposure. As the authors point out, verifiable prospective data is difficult to obtain regarding exposure to smoking in utero or in childhood and recall bias is possible in obtaining historical information in this prospective study given the use of questionnaires, though it remains plausible given prior studies on the association of personal smoking with RA.

 

The involvement of gut microbiota in development of autoimmunity has also been postulated but not well-explained. Several recent studies have examined the impact of antibiotic use on the development of RA, including a recent large UK-based case-control study suggesting an increase in RA incidence in people with antibiotic exposure. While a systematic review is ongoing, this prospective cohort study by Liu et al also examines data from NHSI and NHSII and RA risk in patients exposed to antibiotics, stratified by duration of use (none, ≤14 days, ≥15 days). It is reassuring that in this study neither short term (≤14 days) nor long term (≥15 days) antibiotic use was associated with RA risk. Comparison with prior studies with prescription data, however, is limited given the use of questionnaires to establish duration of recent antibiotic exposure.

 

Fatigue is a common symptom of RA and has a high impact on quality of life in terms of function. The study by Holten et al examines data from the ARCTIC trial in terms of associations between disease activity and fatigue in early RA, as well as change in fatigue with therapy for RA. Fatigue was measured via a visual analog scale (VAS) and did decrease with therapy from baseline; 80% of patients in the study had moderate or high disease activity based on disease activity score (DAS) at baseline and 69% of patients reported fatigue, while 9% of patients had moderate or high disease activity based on DAS at  24 months and 38% reported fatigue. Interestingly, patients who were in remission (per DAS) at 6 months had a reduced risk of fatigue at 24 months. It is hard to interpret this information in a granular way as fatigue is not measured in a standardized way across clinical studies and the only instrument of measure in the ARCTIC trial was the VAS. An alternate view, for example examining the impact of baseline fatigue on response to therapy, may also be reasonable, or fatigue may be a residual symptom similar to chronic myofascial or “non-inflammatory” pain not responsive to treatment in RA.

 

Finally, another associated extra-articular manifestation of RA is bronchiectasis. Martin et al performed a systematic review and meta-analysis of the literature and found that the prevalence of bronchiectasis was about 18% in RA patients, suggesting that it is more common than previously thought. However, inclusion of CT imaging may detect subclinical bronchiectasis and other secondary causes were not determined. Still, given the effects on quality of life and mortality, further research into causes and risk factors for bronchiectasis in RA is warranted.

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RA: Treatment escalation to biologics vs. csDMARD more effective in clinical remission

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Key clinical point: In patients with rheumatoid arthritis (RA) in clinical remission, treat-to-target-based treatment escalations to biologics were more effective than escalation to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in improving magnetic resonance imaging (MRI) inflammation, physical function, and clinical disease activity.

Major finding: Escalation to first biologic vs. csDMARD escalation effectively reduced MRI osteitis (difference between least squares means [∆LSM] 1.8; 95% CI 1.0-2.6), Health Assessment Questionnaire score (∆LSM 0.08; 95% CI 0.03-0.1), MRI combined inflammation (∆LSM 2.5; 95% CI 0.9-4.1), and Simplified Disease Activity Index scores (∆LSM 2.7; 95% CI 1.9-3.5).

Study details: This study evaluated the impact of treatment intensification with csDMARDs and biologics in 100 patients with established RA in clinical remission from the IMAGINE-RA trial, who were randomly assigned to MRI treat-to-target strategy.

Disclosures: This research was funded by AbbVie. Some of the authors reported receiving grants and personal fees from various sources including AbbVie.

Source: Møller-Bisgaard S et al. Scand J Rheumatol. 2021 Sep 2. doi: 10.1080/03009742.2021.1935312.

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Key clinical point: In patients with rheumatoid arthritis (RA) in clinical remission, treat-to-target-based treatment escalations to biologics were more effective than escalation to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in improving magnetic resonance imaging (MRI) inflammation, physical function, and clinical disease activity.

Major finding: Escalation to first biologic vs. csDMARD escalation effectively reduced MRI osteitis (difference between least squares means [∆LSM] 1.8; 95% CI 1.0-2.6), Health Assessment Questionnaire score (∆LSM 0.08; 95% CI 0.03-0.1), MRI combined inflammation (∆LSM 2.5; 95% CI 0.9-4.1), and Simplified Disease Activity Index scores (∆LSM 2.7; 95% CI 1.9-3.5).

Study details: This study evaluated the impact of treatment intensification with csDMARDs and biologics in 100 patients with established RA in clinical remission from the IMAGINE-RA trial, who were randomly assigned to MRI treat-to-target strategy.

Disclosures: This research was funded by AbbVie. Some of the authors reported receiving grants and personal fees from various sources including AbbVie.

Source: Møller-Bisgaard S et al. Scand J Rheumatol. 2021 Sep 2. doi: 10.1080/03009742.2021.1935312.

Key clinical point: In patients with rheumatoid arthritis (RA) in clinical remission, treat-to-target-based treatment escalations to biologics were more effective than escalation to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in improving magnetic resonance imaging (MRI) inflammation, physical function, and clinical disease activity.

Major finding: Escalation to first biologic vs. csDMARD escalation effectively reduced MRI osteitis (difference between least squares means [∆LSM] 1.8; 95% CI 1.0-2.6), Health Assessment Questionnaire score (∆LSM 0.08; 95% CI 0.03-0.1), MRI combined inflammation (∆LSM 2.5; 95% CI 0.9-4.1), and Simplified Disease Activity Index scores (∆LSM 2.7; 95% CI 1.9-3.5).

Study details: This study evaluated the impact of treatment intensification with csDMARDs and biologics in 100 patients with established RA in clinical remission from the IMAGINE-RA trial, who were randomly assigned to MRI treat-to-target strategy.

Disclosures: This research was funded by AbbVie. Some of the authors reported receiving grants and personal fees from various sources including AbbVie.

Source: Møller-Bisgaard S et al. Scand J Rheumatol. 2021 Sep 2. doi: 10.1080/03009742.2021.1935312.

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Abatacept beneficial in csDMARD-refractory RA

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Key clinical point: Abatacept appeared to be more efficacious and safer than adding or switching to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis (RA) of any age who were refractory to csDMARDs.

Major finding: At 24 weeks, European League Against Rheumatism good or moderate response was achieved by a significantly higher proportion of older patients aged 65 years or above (odds ratio [OR] 7.770; P < .0001) and younger patients (OR 4.089; P = .005) receiving abatacept vs. csDMARDs. Few serious adverse events were reported.

Study details: This was a prospective, multicenter study involving 202 bio-naive, csDMARD-refractory patients with RA. The patients were categorized into older (n=67) and younger (n=47) patients receiving abatacept and older (n=48) and younger (n=40) patients receiving csDMARDs.

Disclosures: This study was supported by Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. The authors including the lead author reported receiving grants and personal/consultancy/speakers’ fees from various sources including Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd.

Source: Muraoka S et al. Rheumatol Ther. 2021 Aug 26. doi: 10.1007/s40744-021-00356-2.

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Key clinical point: Abatacept appeared to be more efficacious and safer than adding or switching to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis (RA) of any age who were refractory to csDMARDs.

Major finding: At 24 weeks, European League Against Rheumatism good or moderate response was achieved by a significantly higher proportion of older patients aged 65 years or above (odds ratio [OR] 7.770; P < .0001) and younger patients (OR 4.089; P = .005) receiving abatacept vs. csDMARDs. Few serious adverse events were reported.

Study details: This was a prospective, multicenter study involving 202 bio-naive, csDMARD-refractory patients with RA. The patients were categorized into older (n=67) and younger (n=47) patients receiving abatacept and older (n=48) and younger (n=40) patients receiving csDMARDs.

Disclosures: This study was supported by Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. The authors including the lead author reported receiving grants and personal/consultancy/speakers’ fees from various sources including Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd.

Source: Muraoka S et al. Rheumatol Ther. 2021 Aug 26. doi: 10.1007/s40744-021-00356-2.

Key clinical point: Abatacept appeared to be more efficacious and safer than adding or switching to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis (RA) of any age who were refractory to csDMARDs.

Major finding: At 24 weeks, European League Against Rheumatism good or moderate response was achieved by a significantly higher proportion of older patients aged 65 years or above (odds ratio [OR] 7.770; P < .0001) and younger patients (OR 4.089; P = .005) receiving abatacept vs. csDMARDs. Few serious adverse events were reported.

Study details: This was a prospective, multicenter study involving 202 bio-naive, csDMARD-refractory patients with RA. The patients were categorized into older (n=67) and younger (n=47) patients receiving abatacept and older (n=48) and younger (n=40) patients receiving csDMARDs.

Disclosures: This study was supported by Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. The authors including the lead author reported receiving grants and personal/consultancy/speakers’ fees from various sources including Bristol Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd.

Source: Muraoka S et al. Rheumatol Ther. 2021 Aug 26. doi: 10.1007/s40744-021-00356-2.

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Bronchiectasis is a common extra-articular feature of RA

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Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

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Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

Key clinical point: The incidence of rheumatoid arthritis-related bronchiectasis (RA-BR) was almost 20%, suggesting that bronchiectasis is a common extra-articular feature of rheumatoid arthritis (RA).

Major finding: The pooled overall prevalence of RA-BR was 18.7% (95% CI 13.7%-24.3%) in the random effects meta-analysis and 22.6% (95% CI 16.8%-29.0%) in studies that used high-resolution chest computed tomography imaging.

Study details: Findings are from a systematic review and meta-analysis of 41 studies that reported on RA-BR prevalence, risk factors, or both.

Disclosures: The study did not receive any external funding. Dr. Sparks, Dr. Doyle, and Dr. Shadick reported receiving research support and consultancy fees from various sources.

Source: Martin LW et al. Semin Arthritis Rheum. 2021 Aug 20. doi: 10.1016/j.semarthrit.2021.08.005.

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Early disease remission reduces fatigue risk in RA

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Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

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Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

Key clinical point: Disease activity is associated with fatigue in early rheumatoid arthritis (RA), and patients who achieve early remission are at lower risk for experiencing fatigue.

Major finding: Patients who achieved remission at 6 months had a lower chance of experiencing fatigue at 24 months (Disease Activity Score 44 remission, odds ratio [OR] 0.31; P < .001). Fewer swollen joints (OR 0.92; P = .006), lower power Doppler ultrasound score (OR 0.95; P = .027), and a higher patient global assessment score (OR 1.03; P < .001) raised the likelihood of clinically relevant fatigue at 24 months.

Study details: The findings come from the analysis of 205 individuals from the ARCTIC trial. Patients were randomly assigned to a treat-to-target approach with and without musculoskeletal ultrasonography during clinical examinations and treatment decisions.

Disclosures: This work was supported by the DAM Foundation. Some of the authors declared receiving personal fees, personal honoraria, consultancy honorariums/fees, and serving on the data safety monitoring board or advisory board of various sources.

Source: Holton K et al. Ann Rheum Dis. 2021 Aug 13. doi: 10.1136/annrheumdis-2021-220750.

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No link between recent antibiotic use and RA risk later in life

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Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

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Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

Key clinical point: Over 6 years of prospective follow-up found no association between recent antibiotic use and subsequent risk for rheumatoid arthritis (RA) later in life.

Major finding: Compared with no antibiotic usage, short-term (adjusted hazard ratio [aHR] 0.88; 95% CI 0.38-1.38) and middle-to-long-term (aHR 1.06; 95% CI 0.42-1.71) antibiotic use was not associated with an increased risk for RA.

Study details: The study included 1,33,125 female participants from Nurses' Health Study (NHS; n=58,757) and NHS II (n=74,368) databases. Based on antibiotic usage, participants were categorized into nonuse, short-term use (1-14 days), and middle-to-long-term use (15 or more days) groups.

Disclosures: This work was supported by the Natural Science Foundation of China, the Guangdong Provincial Key Laboratory of Digestive Cancer Research, the Startup Fund for the 100 Top Talents Program, the Sun Yat-sen University, and the National Institutes of Health. All the authors reported no conflict of interests.

Source: Liu Y et al. Expert Opin Drug Saf. 2021 Aug 25. doi: 10.1080/14740338.2021.1970134.

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Impaired long-term outcomes in RA patients treated with CABG

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Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

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Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

Key clinical point: Patients with rheumatoid arthritis (RA) had worse prognosis after coronary artery bypass grafting surgery (CABG) than matched controls.

Major finding: The risk for mortality at 14.3 years’ follow-up after CABG was significantly higher in patients diagnosed with RA than those without (hazard ratio [HR] 1.50; P < .0001). Moreover, patients with RA were at a higher risk for myocardial infarction during the follow-up period (HR 1.61; P < .0001).

Study details: This was a retrospective analysis of patients with RA (n=378) matched with those without RA (n=7,560), all treated with CABG.

Disclosures: The Finnish Cultural Foundation, the Paulon Säätiö Foundation, the Finnish Governmental VTR-funding, and Suomen Kulttuurirahasto funded this study. The authors disclosed receipt of travel grants, consulting/speaker fees, honoraria, and congress sponsorship from and serving on advisory boards for various sources.

Source: Malmberg M et al. Ann Med. 2021 Aug 31. doi: 10.1080/07853890.2021.1969591.

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Joint inflammation tends to recur in the same joints during RA disease course

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Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

 

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Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

 

Key clinical point: Joint swelling associated with rheumatoid arthritis (RA) tends to recur in the same joints swollen at RA onset, even in patients who are intensively treated.

Major finding: Overall, 46% of joints swollen at baseline showed swelling recurrence at least once during follow-up. Baseline joint swelling was predictive for swelling during follow-up (odds ratio [OR] 2.37; P < .001) and recurrent, persistent swelling in joints swollen (OR 1.52) and not swollen (OR 1.73) at the previous visit (both P < .001).

Study details: This is a subanalysis of the BeSt (Behandel-Strategieën) study, a treat-to-target trial involving 508 patients with newly diagnosed active RA followed up for a median of 10 years.

Disclosures: The original BeSt study was funded by a research grant from the Dutch College of Health Insurances with additional funding from Schering-Plough BV and Centocor Inc.

Source: Heckert SL et al. Ann Rheum Dis. 2021 Aug 30. doi: 10.1136/annrheumdis-2021-220882.

 

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