Clinical Edge Journal Scan

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: Treatment with bazedoxifene for 48 weeks significantly increased bone mineral density (BMD) of L-spine and decreased bone turnover markers in postmenopausal women with rheumatoid arthritis (RA) receiving low-dose glucocorticoids.

Major finding: Treatment with bazedoxifene significantly increased L-spine BMD (0.015 g/cm²; P = .007), whereas the change in the control group was not significant (0.002 g/cm²; P = .694). At 24 weeks, all bone turnover biomarkers decreased significantly with bazedoxifene, which persisted to 48 weeks (all P less than .01), whereas recovery observed in the control group was not significant.

Study details: The data come from an open-label study involving 114 postmenopausal women with osteopenia who had been receiving low-dose glucocorticoids for RA and were randomly assigned to either daily bazedoxifene (20 mg/day) with calcium and vitamin D or only calcium and vitamin D (control group).

Disclosures: The study was supported by a research grant from Pfizer Pharmaceuticals Korea Ltd. YK Sung reported receiving research grants from Bristol-Myers Squibb, Eisai, Pfizer, and JW Pharmaceutical.

Source: Cho SK et al. Arthritis Res Ther. 2021 Jul 2. doi: 10.1186/s13075-021-02564-1.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Key clinical point: In patients with active rheumatoid arthritis (RA), adalimumab biosimilar CT-P17 and reference adalimumab showed comparable efficacy and safety during 1 year of treatment even after switching to CT-P17 from reference adalimumab.

Major finding: At 52 weeks, the proportion of patients achieving a 20%/50%/70% improvement by American College of Rheumatology criteria was comparable among those who continued CT-P17 (80.5%/66.3%/44.6%), continued reference adalimumab (77.8%/62.1%/49.0%), or switched to CT-P17 (82.2%/66.4%/47.4%), respectively. Similar proportions of patients in each treatment group experienced 1 or more treatment-emergent adverse events.

Study details: This was a 52-week, randomized, phase 3 study of 607 patients with active RA who received either 40 mg (100 mg/mL) CT-P17 or reference adalimumab subcutaneously every 2 weeks until week 24. Later, patients receiving CT-P17 continued to receive the same, whereas those receiving reference adalimumab either continued the same or switched to CT-P17.

Disclosures: This work was supported by Celltrion, Inc. Some of the authors reported receiving research grants, consulting, speaker fees, and/or honoraria from various sources. SJ Lee, SH Kim, YJ Bae, GE Yang, and JK Yoo declared being employees of Celltrion, Inc.

Source: Furst DE et al. Rheumatology (Oxford). 2021 Jun 17. doi: 10.1093/rheumatology/keab460.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

Recently, ACR guidelines were published on the prevention and treatment of glucocorticoid-induced osteoporosis, emphasizing use of supplemental calcium and vitamin D and antiresorptive therapy. This randomized, controlled, open-label trial by Cho et al looks at the efficacy of selective estrogen receptor modulators (SERMs) in preventing bone loss and fractures in postmenopausal RA patients with osteopenia on long-term glucocorticoids. Patients were randomized to bazedoxefine, a 3^rd-generation SERM vs no therapy in addition to background calcium and vitamin D supplementation and bone mineral density (BMD) and trabecular bone score (TBS). Bone turnover markers were assessed over the course of 48 weeks, in addition to adverse events. Prednisone dose was relatively low, with a baseline of ~3 mg/day. Bone density increased by almost 2% in the L spine (P < 0.05), but the increases in BMD at the femoral neck and TBS were not significant. Bone turnover markers did decrease in the bazedoxefine group, though not in the control group. These findings are not striking but are promising given the short duration of the study (<1 year), and potentially deserves longer-term follow-up, both for evaluation of efficacy as well as long-term safety. In the US, the medication is only available in combination with estrogen, and thus it is not currently a practical option for RA patients with GIOP.

Despite wider availability of both synthetic and biologic DMARDs for treatment of RA in recent years, persistent pain is an issue for many patients, perhaps due to peripheral sensitization. Though it seems almost unnecessary to investigate the utility of glucocorticoids for treatment of RA-related pain, the magnitude and duration of their benefit is unknown. McWilliams et al take the approach of quantitatively analyzing the benefit of glucocorticoids in RA over time in their systematic review and meta-analysis. The study looked at both spontaneous and evoked pain, and evaluated 65 studies that mostly used pain visual analogue scale, tender joint count, and Ritchie Articular Index. Reduction in spontaneous pain was greatest in the 0-3-month time period, with smaller reductions in 3-6 months and >6 month. A similar pattern was seen in evaluation of the time course of evoked pain. As such, the benefits of long-term systemic glucocorticoid therapy may not outweigh its well-known risks, especially in patients with persistent pain. Whether this is due to non-inflammatory sources of pain or other mechanisms remains unknown and is likely heavily impacted by the specific clinical scenario.

Due to the potential long-terms side effects of chronic immunosuppression, including long-term glucocorticoid therapy in patients with persistent pain in RA, the course and predictors of unacceptable pain are of interest. Eberhard et al examined an inception cohort of RA patients in a single center in Sweden over the course of 5 years. They were found to have reduction of VAS pain from inclusion to 6 months, but pain levels largely stayed the same during the rest of the follow-up period. The proportion of patients with unacceptable pain also decreased but remained stable at about 30% after 1 year, with 20% having unacceptable pain and low inflammation and about 10% having high inflammation and unacceptable pain. The study found seropositivity, high inflammatory parameters, high DAS28 and severe patient-reported outcomes to be predictive of high inflammation and unacceptable pain and lower age, higher VAS pain, and low ESR to be predictive of low inflammation and unacceptable pain. These findings highlight the importance of examining non-inflammatory mechanisms of pain as well as identifying treatments; however, in evaluating the risk of immunosuppression and glucocorticoid therapy, it does not guide increasing or reducing treatment in RA patients with persistent pain.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.

Key clinical point: Overall, oral contraceptives were more effective than placebo for treating symptoms of PMS and PMDD, but none of the combined oral contraceptives stood out as more effective than the others, and oral contraceptives had no apparent impact on premenstrual depressive symptoms.

Major finding:  In a pairwise meta-analysis, combined oral contraceptives showed no effectiveness compared to placebo for reducing premenstrual depressive symptoms, with a standardized mean difference of 0.22. However, combined oral contraceptive use overall was moderately effective compared to placebo for improving premenstrual symptomatology overall (standardized mean difference 0.41).

Study details: The data come from a meta-analysis of nine randomized clinical trials including 1,205 women aged approximately 24-37 years who reported premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).  

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: De Wit AE et al. Am J Obstet Gynecol. 2021 Jul 2. doi: 10.1016/j.ajog.2021.06.090. 

Key clinical point: Overall, oral contraceptives were more effective than placebo for treating symptoms of PMS and PMDD, but none of the combined oral contraceptives stood out as more effective than the others, and oral contraceptives had no apparent impact on premenstrual depressive symptoms.

Major finding:  In a pairwise meta-analysis, combined oral contraceptives showed no effectiveness compared to placebo for reducing premenstrual depressive symptoms, with a standardized mean difference of 0.22. However, combined oral contraceptive use overall was moderately effective compared to placebo for improving premenstrual symptomatology overall (standardized mean difference 0.41).

Study details: The data come from a meta-analysis of nine randomized clinical trials including 1,205 women aged approximately 24-37 years who reported premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).  

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: De Wit AE et al. Am J Obstet Gynecol. 2021 Jul 2. doi: 10.1016/j.ajog.2021.06.090. 

Key clinical point: Overall, oral contraceptives were more effective than placebo for treating symptoms of PMS and PMDD, but none of the combined oral contraceptives stood out as more effective than the others, and oral contraceptives had no apparent impact on premenstrual depressive symptoms.

Major finding:  In a pairwise meta-analysis, combined oral contraceptives showed no effectiveness compared to placebo for reducing premenstrual depressive symptoms, with a standardized mean difference of 0.22. However, combined oral contraceptive use overall was moderately effective compared to placebo for improving premenstrual symptomatology overall (standardized mean difference 0.41).

Study details: The data come from a meta-analysis of nine randomized clinical trials including 1,205 women aged approximately 24-37 years who reported premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).  

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: De Wit AE et al. Am J Obstet Gynecol. 2021 Jul 2. doi: 10.1016/j.ajog.2021.06.090. 

Key clinical point: Adolescent oral contraceptive use was associated with a significant increase in risk of major depressive disorder in young adulthood; the results may help inform choices for contraceptive methods.

Major finding:  Use of oral contraceptives at age 16-19 years was significantly associated with an episode of major depressive disorder at age 20-25 years (odds ratio 1.41, P < .001). The association was slightly higher among young women with no previous history of major depressive disorder.

Study details: The data come from a prospective cohort study of 725 women who participated in the Tracking Adolescents’ Individual Lives (TRAILS) study in Denmark. Use of OCs at ages 16-19 years was assessed as a predictor of major depressive disorder at ages 20-25 years based on the Diagnostic and Statistical Manual of Mental Disorders-IV oriented Lifetime Depression Assessment Self-Report and the Composite International Diagnostic Interview.

Disclosures: The larger TRAILS study was supported by Netherlands Organization for Scientific Research NWO, the Dutch Ministry of Justice, the European Science Foundation, the European Research Council, Biobanking and Biomolecular Resources Research Infrastructure, the Gratama Foundation, the Jan Dekker Foundation, the participating universities, and Accare Centre for Child and Adolescent Psychiatry. This specific study was also supported by the Feodor Lynen Research Fellowship from the Alexander von Humboldt-Foundation and a Canadian Institutes of Health Research Project Grant awarded to study authors. The researchers had no financial conflicts to disclose.

Source: Anderl C et al. J Child Psychol Psychiatry. 2021 Jul 12. doi: 10.1111/jcpp.13476. 

Key clinical point: Adolescent oral contraceptive use was associated with a significant increase in risk of major depressive disorder in young adulthood; the results may help inform choices for contraceptive methods.

Major finding:  Use of oral contraceptives at age 16-19 years was significantly associated with an episode of major depressive disorder at age 20-25 years (odds ratio 1.41, P < .001). The association was slightly higher among young women with no previous history of major depressive disorder.

Study details: The data come from a prospective cohort study of 725 women who participated in the Tracking Adolescents’ Individual Lives (TRAILS) study in Denmark. Use of OCs at ages 16-19 years was assessed as a predictor of major depressive disorder at ages 20-25 years based on the Diagnostic and Statistical Manual of Mental Disorders-IV oriented Lifetime Depression Assessment Self-Report and the Composite International Diagnostic Interview.

Disclosures: The larger TRAILS study was supported by Netherlands Organization for Scientific Research NWO, the Dutch Ministry of Justice, the European Science Foundation, the European Research Council, Biobanking and Biomolecular Resources Research Infrastructure, the Gratama Foundation, the Jan Dekker Foundation, the participating universities, and Accare Centre for Child and Adolescent Psychiatry. This specific study was also supported by the Feodor Lynen Research Fellowship from the Alexander von Humboldt-Foundation and a Canadian Institutes of Health Research Project Grant awarded to study authors. The researchers had no financial conflicts to disclose.

Source: Anderl C et al. J Child Psychol Psychiatry. 2021 Jul 12. doi: 10.1111/jcpp.13476. 

Key clinical point: Adolescent oral contraceptive use was associated with a significant increase in risk of major depressive disorder in young adulthood; the results may help inform choices for contraceptive methods.

Major finding:  Use of oral contraceptives at age 16-19 years was significantly associated with an episode of major depressive disorder at age 20-25 years (odds ratio 1.41, P < .001). The association was slightly higher among young women with no previous history of major depressive disorder.

Study details: The data come from a prospective cohort study of 725 women who participated in the Tracking Adolescents’ Individual Lives (TRAILS) study in Denmark. Use of OCs at ages 16-19 years was assessed as a predictor of major depressive disorder at ages 20-25 years based on the Diagnostic and Statistical Manual of Mental Disorders-IV oriented Lifetime Depression Assessment Self-Report and the Composite International Diagnostic Interview.

Disclosures: The larger TRAILS study was supported by Netherlands Organization for Scientific Research NWO, the Dutch Ministry of Justice, the European Science Foundation, the European Research Council, Biobanking and Biomolecular Resources Research Infrastructure, the Gratama Foundation, the Jan Dekker Foundation, the participating universities, and Accare Centre for Child and Adolescent Psychiatry. This specific study was also supported by the Feodor Lynen Research Fellowship from the Alexander von Humboldt-Foundation and a Canadian Institutes of Health Research Project Grant awarded to study authors. The researchers had no financial conflicts to disclose.

Source: Anderl C et al. J Child Psychol Psychiatry. 2021 Jul 12. doi: 10.1111/jcpp.13476. 

Key clinical point: A uterine sound-sparing approach significantly increased patient satisfaction with IUD insertion compared to a trans-abdominal ultrasound guided approach.

Major finding:  The VAS scores for patient satisfaction were significantly higher in women who underwent IUD placement with the USSA approach compared to the TVS approach (7.80 vs 5.45, P = .0001). Significantly lower VAS pain scores and significantly shorter duration of insertion also were reported in the USSA group compared to the TVS group (P = .001 and P = .0001, respectively).

Study details: The data come from a randomized, open-label study of multiparous women who requested copper IUD insertion for birth control; 44 women underwent placement with the trans-abdominal ultrasound (TAS) guided approach and 44 with the uterine sound-sparing approach (USSA).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ali MK et al. Eur J Contracept Reprod Health Care. 2021 Apr 15. doi: 10.1080/13625187.2021.1900565.

Key clinical point: A uterine sound-sparing approach significantly increased patient satisfaction with IUD insertion compared to a trans-abdominal ultrasound guided approach.

Major finding:  The VAS scores for patient satisfaction were significantly higher in women who underwent IUD placement with the USSA approach compared to the TVS approach (7.80 vs 5.45, P = .0001). Significantly lower VAS pain scores and significantly shorter duration of insertion also were reported in the USSA group compared to the TVS group (P = .001 and P = .0001, respectively).

Study details: The data come from a randomized, open-label study of multiparous women who requested copper IUD insertion for birth control; 44 women underwent placement with the trans-abdominal ultrasound (TAS) guided approach and 44 with the uterine sound-sparing approach (USSA).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ali MK et al. Eur J Contracept Reprod Health Care. 2021 Apr 15. doi: 10.1080/13625187.2021.1900565.

Key clinical point: A uterine sound-sparing approach significantly increased patient satisfaction with IUD insertion compared to a trans-abdominal ultrasound guided approach.

Major finding:  The VAS scores for patient satisfaction were significantly higher in women who underwent IUD placement with the USSA approach compared to the TVS approach (7.80 vs 5.45, P = .0001). Significantly lower VAS pain scores and significantly shorter duration of insertion also were reported in the USSA group compared to the TVS group (P = .001 and P = .0001, respectively).

Study details: The data come from a randomized, open-label study of multiparous women who requested copper IUD insertion for birth control; 44 women underwent placement with the trans-abdominal ultrasound (TAS) guided approach and 44 with the uterine sound-sparing approach (USSA).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ali MK et al. Eur J Contracept Reprod Health Care. 2021 Apr 15. doi: 10.1080/13625187.2021.1900565.

Key clinical point: Users of hormone-containing intrauterine  (HIUD) devices had no significant increase in risk of developing precancerous cervical lesions than women who used other contraceptives.

Major finding: Women who used hormone-containing IUDs had the same risk as users of copper IUDs (CIUD) of developing cervical intraepithelial neoplasia 3+ (CIN3+) with adjusted relative risk of 1.08 over 5 years. The risk of CIN3+ was lower for the HIUD group and CIUD group compared to users of oral contraceptives (aRR 0.63 and aRR 0.58, respectively).

Study details: The data come from a population-based cohort study of women aged 26-50 years in Denmark, using registry data from 2008 to 2011; the study population included 60,551 users of HIUDs, 30,303 users of CIUDs, and 165,627 users of oral contraceptives.

Disclosures: The study was supported by the A.P. Møller Foundation for the Advancement of Medical Science, the Else and Mogens Wedell-Wedellborgs Fund, the Direktør Emil C. Hertz og Hustru Inger Hertz Fund, and the Fund for Development of Evidence Based Medicine in Private Specialized Practices. Lead author Dr. Skortengaard had no financial conflicts to disclose.

Source: Skortengaard M et al. Hum Reprod. 2021 Jun 18. doi: 10.1093/humrep/deab066.

Key clinical point: Users of hormone-containing intrauterine  (HIUD) devices had no significant increase in risk of developing precancerous cervical lesions than women who used other contraceptives.

Major finding: Women who used hormone-containing IUDs had the same risk as users of copper IUDs (CIUD) of developing cervical intraepithelial neoplasia 3+ (CIN3+) with adjusted relative risk of 1.08 over 5 years. The risk of CIN3+ was lower for the HIUD group and CIUD group compared to users of oral contraceptives (aRR 0.63 and aRR 0.58, respectively).

Study details: The data come from a population-based cohort study of women aged 26-50 years in Denmark, using registry data from 2008 to 2011; the study population included 60,551 users of HIUDs, 30,303 users of CIUDs, and 165,627 users of oral contraceptives.

Disclosures: The study was supported by the A.P. Møller Foundation for the Advancement of Medical Science, the Else and Mogens Wedell-Wedellborgs Fund, the Direktør Emil C. Hertz og Hustru Inger Hertz Fund, and the Fund for Development of Evidence Based Medicine in Private Specialized Practices. Lead author Dr. Skortengaard had no financial conflicts to disclose.

Source: Skortengaard M et al. Hum Reprod. 2021 Jun 18. doi: 10.1093/humrep/deab066.

Key clinical point: Users of hormone-containing intrauterine  (HIUD) devices had no significant increase in risk of developing precancerous cervical lesions than women who used other contraceptives.

Major finding: Women who used hormone-containing IUDs had the same risk as users of copper IUDs (CIUD) of developing cervical intraepithelial neoplasia 3+ (CIN3+) with adjusted relative risk of 1.08 over 5 years. The risk of CIN3+ was lower for the HIUD group and CIUD group compared to users of oral contraceptives (aRR 0.63 and aRR 0.58, respectively).

Study details: The data come from a population-based cohort study of women aged 26-50 years in Denmark, using registry data from 2008 to 2011; the study population included 60,551 users of HIUDs, 30,303 users of CIUDs, and 165,627 users of oral contraceptives.

Disclosures: The study was supported by the A.P. Møller Foundation for the Advancement of Medical Science, the Else and Mogens Wedell-Wedellborgs Fund, the Direktør Emil C. Hertz og Hustru Inger Hertz Fund, and the Fund for Development of Evidence Based Medicine in Private Specialized Practices. Lead author Dr. Skortengaard had no financial conflicts to disclose.

Source: Skortengaard M et al. Hum Reprod. 2021 Jun 18. doi: 10.1093/humrep/deab066.