Clinical Edge Journal Scan

Key clinical point: Current use of hormonal contraceptives was associated with lower mean levels of anti-Müllerian hormone compared to levels in women not on contraceptives; the data may guide clinicians in counseling women to continue their contraceptives during evaluation of ovarian reserve.

Major finding: Compared to women not using any contraceptives, mean anti-Müllerian hormone levels were significantly lower in women using a combined oral contraceptive pill (23.68%), vaginal ring (22.07%), hormonal intrauterine device (6.73%), implant (23.44%), or progestin-only pill (14.80%).

Study details: The data come from a cross-sectional study of 27,125 women aged 20-46 years in the United States. The researchers used dried blood spot cards or venipuncture to assess anti-Müllerian hormone levels.

Disclosures: Modern Fertility, manufacturer of the tests used in the study, paid salaries and consulting fees to the study authors. Lead author Dr. Hariton is a paid consultant for Modern Fertility, has stock options in the company, and his spouse is a Modern Fertility employee.

Source: Hariton E et al. Am J Obstet Gynecol. 2021 Jun 12. doi: 10.1016/j.ajog.2021.06.052.

Key clinical point: Current use of hormonal contraceptives was associated with lower mean levels of anti-Müllerian hormone compared to levels in women not on contraceptives; the data may guide clinicians in counseling women to continue their contraceptives during evaluation of ovarian reserve.

Major finding: Compared to women not using any contraceptives, mean anti-Müllerian hormone levels were significantly lower in women using a combined oral contraceptive pill (23.68%), vaginal ring (22.07%), hormonal intrauterine device (6.73%), implant (23.44%), or progestin-only pill (14.80%).

Study details: The data come from a cross-sectional study of 27,125 women aged 20-46 years in the United States. The researchers used dried blood spot cards or venipuncture to assess anti-Müllerian hormone levels.

Disclosures: Modern Fertility, manufacturer of the tests used in the study, paid salaries and consulting fees to the study authors. Lead author Dr. Hariton is a paid consultant for Modern Fertility, has stock options in the company, and his spouse is a Modern Fertility employee.

Source: Hariton E et al. Am J Obstet Gynecol. 2021 Jun 12. doi: 10.1016/j.ajog.2021.06.052.

Key clinical point: Current use of hormonal contraceptives was associated with lower mean levels of anti-Müllerian hormone compared to levels in women not on contraceptives; the data may guide clinicians in counseling women to continue their contraceptives during evaluation of ovarian reserve.

Major finding: Compared to women not using any contraceptives, mean anti-Müllerian hormone levels were significantly lower in women using a combined oral contraceptive pill (23.68%), vaginal ring (22.07%), hormonal intrauterine device (6.73%), implant (23.44%), or progestin-only pill (14.80%).

Study details: The data come from a cross-sectional study of 27,125 women aged 20-46 years in the United States. The researchers used dried blood spot cards or venipuncture to assess anti-Müllerian hormone levels.

Disclosures: Modern Fertility, manufacturer of the tests used in the study, paid salaries and consulting fees to the study authors. Lead author Dr. Hariton is a paid consultant for Modern Fertility, has stock options in the company, and his spouse is a Modern Fertility employee.

Source: Hariton E et al. Am J Obstet Gynecol. 2021 Jun 12. doi: 10.1016/j.ajog.2021.06.052.

Key clinical point: Pregnancy rates were low following placement of an IUD for emergency contraception, including among women who resumed intercourse within days of IUD placement without backup contraception.

Major finding:  No pregnancies were reported among 138 women who received levonorgestrel IUS or among 148 who received copper IUDs who reported intercourse within 7 days of placement, regardless of use of backup contraception.

Study details: The data come from a secondary analysis of 518 participants in a randomized controlled trial of IUDs for emergency contraception; participants received a 52 mg levonorgestrel intrauterine system (IUS) or 380 mm2 copper IUD.

Disclosures: The study was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Development, the University of Utah Population Health Research (PHR) Foundation, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health. The Division of Family Planning in the University of Utah's Department of Obstetrics and Gynecology receives research funding from Bayer Women's Health Care, Merck & Co. Inc., Cooper Surgical, Sebela Pharmaceuticals, Femasys, and Medicines 360. Lead author Dr. Fay had no financial conflicts to disclose.

Source: Fay KE et al. Contraception. 2021 Jun 21. doi: 10.1016/j.contraception.2021.06.011.

Key clinical point: Pregnancy rates were low following placement of an IUD for emergency contraception, including among women who resumed intercourse within days of IUD placement without backup contraception.

Major finding:  No pregnancies were reported among 138 women who received levonorgestrel IUS or among 148 who received copper IUDs who reported intercourse within 7 days of placement, regardless of use of backup contraception.

Study details: The data come from a secondary analysis of 518 participants in a randomized controlled trial of IUDs for emergency contraception; participants received a 52 mg levonorgestrel intrauterine system (IUS) or 380 mm2 copper IUD.

Disclosures: The study was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Development, the University of Utah Population Health Research (PHR) Foundation, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health. The Division of Family Planning in the University of Utah's Department of Obstetrics and Gynecology receives research funding from Bayer Women's Health Care, Merck & Co. Inc., Cooper Surgical, Sebela Pharmaceuticals, Femasys, and Medicines 360. Lead author Dr. Fay had no financial conflicts to disclose.

Source: Fay KE et al. Contraception. 2021 Jun 21. doi: 10.1016/j.contraception.2021.06.011.

Key clinical point: Pregnancy rates were low following placement of an IUD for emergency contraception, including among women who resumed intercourse within days of IUD placement without backup contraception.

Major finding:  No pregnancies were reported among 138 women who received levonorgestrel IUS or among 148 who received copper IUDs who reported intercourse within 7 days of placement, regardless of use of backup contraception.

Study details: The data come from a secondary analysis of 518 participants in a randomized controlled trial of IUDs for emergency contraception; participants received a 52 mg levonorgestrel intrauterine system (IUS) or 380 mm2 copper IUD.

Disclosures: The study was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Development, the University of Utah Population Health Research (PHR) Foundation, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health. The Division of Family Planning in the University of Utah's Department of Obstetrics and Gynecology receives research funding from Bayer Women's Health Care, Merck & Co. Inc., Cooper Surgical, Sebela Pharmaceuticals, Femasys, and Medicines 360. Lead author Dr. Fay had no financial conflicts to disclose.

Source: Fay KE et al. Contraception. 2021 Jun 21. doi: 10.1016/j.contraception.2021.06.011.

Key clinical point: Rates of continuation and satisfaction were high among women who underwent placement of IUDs during cesarean deliveries, with two cases of infection and no cases of perforation or pregnancy reported.

Major finding:  Rates of IUD continuation were 92% at 6 weeks and 71.5% at 6 months; and approximately 85% and 76% of the women reported satisfaction with the devices at 6 weeks and 6 months, respectively.

Study details: The data come from a prospective, observational study of 158 women in Brazil who received copper IUDs during cesarean deliveries, with follow-up at 6 weeks and 6 months after IUD placement.

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

Source: Uchoa de Albuquerque C et al. Eur J Contracept Reprod Health Care. 2021 Jun 29. doi: 10.1080/13625187.2021.1943739.

Key clinical point: Rates of continuation and satisfaction were high among women who underwent placement of IUDs during cesarean deliveries, with two cases of infection and no cases of perforation or pregnancy reported.

Major finding:  Rates of IUD continuation were 92% at 6 weeks and 71.5% at 6 months; and approximately 85% and 76% of the women reported satisfaction with the devices at 6 weeks and 6 months, respectively.

Study details: The data come from a prospective, observational study of 158 women in Brazil who received copper IUDs during cesarean deliveries, with follow-up at 6 weeks and 6 months after IUD placement.

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

Source: Uchoa de Albuquerque C et al. Eur J Contracept Reprod Health Care. 2021 Jun 29. doi: 10.1080/13625187.2021.1943739.

Key clinical point: Rates of continuation and satisfaction were high among women who underwent placement of IUDs during cesarean deliveries, with two cases of infection and no cases of perforation or pregnancy reported.

Major finding:  Rates of IUD continuation were 92% at 6 weeks and 71.5% at 6 months; and approximately 85% and 76% of the women reported satisfaction with the devices at 6 weeks and 6 months, respectively.

Study details: The data come from a prospective, observational study of 158 women in Brazil who received copper IUDs during cesarean deliveries, with follow-up at 6 weeks and 6 months after IUD placement.

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

Source: Uchoa de Albuquerque C et al. Eur J Contracept Reprod Health Care. 2021 Jun 29. doi: 10.1080/13625187.2021.1943739.

Levonorgestrel intrauterine devices (LNG IUD) are a hot topic in contraceptive research. A recent study on LNG IUDs published by Fay KE et al evaluated pregnancy rates in US women who received LNG or copper IUDs for emergency contraception and reported intercourse within 7 days of insertion. Zero pregnancies were reported in women who resumed intercourse within 7 days of IUD insertion for both the LNG IUD and copper IUD, even in women who had multiple unprotected sexual encounters.  LNG IUDs are more readily accessible and better tolerated than their copper IUD counterparts, and expanding their use will only continue to improve access to reliable contraception. Women often resume penetrative intercourse shortly after initiating new contraceptive method despite counseling. Patients can be reassured that placement of a LNG IUD appears to provide immediate contraceptive benefit.

 A new estrogen is on the market for use in combined oral contraceptive pills (COC). Estetrol is a natural estrogen produced by the human fetal liver only found in circulation during pregnancy.  Estetrol was previously studied for use in menopausal hormone therapy as it acts as a mixed agonist and antagonist, offering a potential improved side effect profile with less activity in the breast and liver.  Estetrol (15 mg) was combined with 3 mg of drospirinone for a novel combined oral contraceptive option in a study by Gemzell-Danielsson K et al.  The pregnancy rate was similar to traditional COCs, demonstrating good contraceptive efficacy. Bleeding patterns and side effects were similar to traditional COCs, and one case of venous thromboembolism was reported in the large study population. A phase III trial with similar results has been completed and this new oral contraceptive formulation recently received FDA approval and is now marketed as Nextstellis. This new oral contraceptive pill hopefully represents a novel option for women who desire COCs with a low androgenic profile and VTE risk or have failed other COC formulations.  

Women are increasingly delaying childbearing, utilizing a variety of contraceptive options to avoid pregnancy. Many proactively seek to determine their fertility potential and clinicians often utilize anti-Müllerian hormone (AMH) as the standard biomarker for assessing ovarian reserve, as it is cycle independent and can be drawn at any time during a woman’s clinical assessment.  Hormonal contraception suppresses ovulation by gonadotropin suppression as a means of contraceptive action, and thus could impact an AMH value. A fascinating study by Hariton E et al looked at all contraceptive options and their impact on AMH values. AMH levels were significantly lower in women using COCs, implants, progestin-only pills, and vaginal rings compared to patients not using contraceptives, and AMH levels were slightly lower in women using hormonal IUDs. These results help clinicians counsel patients on expectations for AMH levels while on contraceptives and can guide future research to generate contraceptive-specific ranges. Women using contraceptives should be counseled to retest after stopping if AMH levels are low.

Levonorgestrel intrauterine devices (LNG IUD) are a hot topic in contraceptive research. A recent study on LNG IUDs published by Fay KE et al evaluated pregnancy rates in US women who received LNG or copper IUDs for emergency contraception and reported intercourse within 7 days of insertion. Zero pregnancies were reported in women who resumed intercourse within 7 days of IUD insertion for both the LNG IUD and copper IUD, even in women who had multiple unprotected sexual encounters.  LNG IUDs are more readily accessible and better tolerated than their copper IUD counterparts, and expanding their use will only continue to improve access to reliable contraception. Women often resume penetrative intercourse shortly after initiating new contraceptive method despite counseling. Patients can be reassured that placement of a LNG IUD appears to provide immediate contraceptive benefit.

 A new estrogen is on the market for use in combined oral contraceptive pills (COC). Estetrol is a natural estrogen produced by the human fetal liver only found in circulation during pregnancy.  Estetrol was previously studied for use in menopausal hormone therapy as it acts as a mixed agonist and antagonist, offering a potential improved side effect profile with less activity in the breast and liver.  Estetrol (15 mg) was combined with 3 mg of drospirinone for a novel combined oral contraceptive option in a study by Gemzell-Danielsson K et al.  The pregnancy rate was similar to traditional COCs, demonstrating good contraceptive efficacy. Bleeding patterns and side effects were similar to traditional COCs, and one case of venous thromboembolism was reported in the large study population. A phase III trial with similar results has been completed and this new oral contraceptive formulation recently received FDA approval and is now marketed as Nextstellis. This new oral contraceptive pill hopefully represents a novel option for women who desire COCs with a low androgenic profile and VTE risk or have failed other COC formulations.  

Women are increasingly delaying childbearing, utilizing a variety of contraceptive options to avoid pregnancy. Many proactively seek to determine their fertility potential and clinicians often utilize anti-Müllerian hormone (AMH) as the standard biomarker for assessing ovarian reserve, as it is cycle independent and can be drawn at any time during a woman’s clinical assessment.  Hormonal contraception suppresses ovulation by gonadotropin suppression as a means of contraceptive action, and thus could impact an AMH value. A fascinating study by Hariton E et al looked at all contraceptive options and their impact on AMH values. AMH levels were significantly lower in women using COCs, implants, progestin-only pills, and vaginal rings compared to patients not using contraceptives, and AMH levels were slightly lower in women using hormonal IUDs. These results help clinicians counsel patients on expectations for AMH levels while on contraceptives and can guide future research to generate contraceptive-specific ranges. Women using contraceptives should be counseled to retest after stopping if AMH levels are low.

Levonorgestrel intrauterine devices (LNG IUD) are a hot topic in contraceptive research. A recent study on LNG IUDs published by Fay KE et al evaluated pregnancy rates in US women who received LNG or copper IUDs for emergency contraception and reported intercourse within 7 days of insertion. Zero pregnancies were reported in women who resumed intercourse within 7 days of IUD insertion for both the LNG IUD and copper IUD, even in women who had multiple unprotected sexual encounters.  LNG IUDs are more readily accessible and better tolerated than their copper IUD counterparts, and expanding their use will only continue to improve access to reliable contraception. Women often resume penetrative intercourse shortly after initiating new contraceptive method despite counseling. Patients can be reassured that placement of a LNG IUD appears to provide immediate contraceptive benefit.

 A new estrogen is on the market for use in combined oral contraceptive pills (COC). Estetrol is a natural estrogen produced by the human fetal liver only found in circulation during pregnancy.  Estetrol was previously studied for use in menopausal hormone therapy as it acts as a mixed agonist and antagonist, offering a potential improved side effect profile with less activity in the breast and liver.  Estetrol (15 mg) was combined with 3 mg of drospirinone for a novel combined oral contraceptive option in a study by Gemzell-Danielsson K et al.  The pregnancy rate was similar to traditional COCs, demonstrating good contraceptive efficacy. Bleeding patterns and side effects were similar to traditional COCs, and one case of venous thromboembolism was reported in the large study population. A phase III trial with similar results has been completed and this new oral contraceptive formulation recently received FDA approval and is now marketed as Nextstellis. This new oral contraceptive pill hopefully represents a novel option for women who desire COCs with a low androgenic profile and VTE risk or have failed other COC formulations.  

Women are increasingly delaying childbearing, utilizing a variety of contraceptive options to avoid pregnancy. Many proactively seek to determine their fertility potential and clinicians often utilize anti-Müllerian hormone (AMH) as the standard biomarker for assessing ovarian reserve, as it is cycle independent and can be drawn at any time during a woman’s clinical assessment.  Hormonal contraception suppresses ovulation by gonadotropin suppression as a means of contraceptive action, and thus could impact an AMH value. A fascinating study by Hariton E et al looked at all contraceptive options and their impact on AMH values. AMH levels were significantly lower in women using COCs, implants, progestin-only pills, and vaginal rings compared to patients not using contraceptives, and AMH levels were slightly lower in women using hormonal IUDs. These results help clinicians counsel patients on expectations for AMH levels while on contraceptives and can guide future research to generate contraceptive-specific ranges. Women using contraceptives should be counseled to retest after stopping if AMH levels are low.

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.

In most patients with psoriatic arthritis (PsA), the musculoskeletal manifestations occur after the onset of cutaneous manifestations. The mechanisms underlying the triggering of joint disease is still not well understood, one burning question is whether early and effective treatment of cutaneous psoriasis will reduce the incidence of PsA. In a retrospective non-randomised study, Gisondi et al compared the incidence rates of PsA in patients with chronic plaque psoriasis receiving either continuous treatment with a biologic disease modifying anti-rheumatic drugs (bDMARD- infliximab, etanercept, adalimumab, ustekinumab and secukinumab) for at least 5 years (n=234, 1584 person-year of follow-up) or at least three courses of narrow band ultraviolet B (nb-UVB) phototherapy (n=230, 1478 person-year of follow-up). bDMARDs treatment was associated with a lower risk of incident PsA (adjusted hazard ratio 0.27, 95% Confidence Interval 0.11–0.66). However, analysis after propensity score matching found no significant difference between treatment with bDMARDs and nb-UVB phototherapy and the risk of incident PsA. Prospective studies are required to answer this important question. Interestingly, nail psoriasis was associated with higher risk of PsA, confirming previous observations.

Due to lack of disease activity biomarkers clinical assessment of disease activity in PsA patients with concomitant fibromyalgia can be challenging. Ultrasound (US) may however be useful in providing objective assessment of disease activity. Polachek et al compared 42 patients with PsA and coexisting fibromyalgia syndrome (FMS) (satisfying CASPAR criteria and the 2016 fibromyalgia classification criteria) to 114 PsA patients without FMS (satisfying CASPAR criteria alone). All patients underwent detailed US evaluation including 52 joints, 40 tendons and 14 entheses, and a scores for synovitis, tenosynovitis and enthesitis were summed to obtain a final US disease activity score for each patient. Those with FMS had higher scores of composite clinical disease activity indices. However, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with composite indices in PsA patients without FMS but not in PsA patients with FMS. Thus, US is a tool that can be employed to determine PsA disease activity in patients with concomitant FMS. However, the scanning protocol as described is time consuming. A shortened protocol as well as training of rheumatologists and radiologists for reliably assessing synovitis, tenosynovitis and enthesitis is required before US can be feasibly and reliably used in clinical practice.

IL-23 inhibitors were not found to be efficacious in the treatment of axial spondyloarthritis. It is not clear whether these inhibitors improve axial disease in PsA patients, and if indeed axial PsA is distinct from primary axial spondyloarthritis. In a post-hoc analyses of the DISCOVER 1 and DISCOVER 2 studies that included 312 patients with PsA with imaging-confirmed sacroiliitis randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91), Mease et al demonstrated that at week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52. Thus, Guselkumab may improve axial PsA. However, axial PsA has not yet been formally defined, and BASDAI and ASDAS are not specific for axial PsA. Once axial PsA is defined, prospective randomised clinical trials with associated MRI studies will be required to determine if IL-23 inhibitors improve symptoms of axial PsA.

Key clinical point: Among patients with psoriatic arthritis (PsA), risk for major adverse cardiovascular events (MACEs) was higher in those who initiated interleukin (IL)12/23 and IL17 inhibitors vs tumor necrosis factor (TNF) inhibitors. However, risk for MACEs was not different among new-users of TNF inhibitors or apremilast.

Major finding: Overall, 51 MACEs (crude incidence rate, 3.4/1,000 patient-years) were observed. The risk of MACEs was higher (P less than .0001) with IL12/23 (weighted hazard ratio [wHR], 2.0; 95% confidence interval [CI], 1.3-3.0) and IL17 (wHR, 1.9; 95% CI, 1.2-3.0) inhibitors but not with apremilast (wHR, 1.3; 95% CI, 0.8-2.2) vs TNF inhibitors.

Study details: Findings are from a nationwide PsA cohort without a history of cardiovascular diseases involving 9,510 new users of biological disease-modifying anti-rheumatic drugs (TNF inhibitor, n=7289; IL12/23 inhibitor, n=1058; IL17 inhibitor, n=1,163) and 1,885 new users of apremilast.

Disclosures: The study did not receive any funding. P Claudepierre reported receiving consulting fees from and being an investigator for various pharmaceutical companies. Other authors declared no conflicts of interest.

Source: Vegas LP et al. Rheumatology. 2021 Jul 9. doi: 10.1093/rheumatology/keab522.

Key clinical point: Among patients with psoriatic arthritis (PsA), risk for major adverse cardiovascular events (MACEs) was higher in those who initiated interleukin (IL)12/23 and IL17 inhibitors vs tumor necrosis factor (TNF) inhibitors. However, risk for MACEs was not different among new-users of TNF inhibitors or apremilast.

Major finding: Overall, 51 MACEs (crude incidence rate, 3.4/1,000 patient-years) were observed. The risk of MACEs was higher (P less than .0001) with IL12/23 (weighted hazard ratio [wHR], 2.0; 95% confidence interval [CI], 1.3-3.0) and IL17 (wHR, 1.9; 95% CI, 1.2-3.0) inhibitors but not with apremilast (wHR, 1.3; 95% CI, 0.8-2.2) vs TNF inhibitors.

Study details: Findings are from a nationwide PsA cohort without a history of cardiovascular diseases involving 9,510 new users of biological disease-modifying anti-rheumatic drugs (TNF inhibitor, n=7289; IL12/23 inhibitor, n=1058; IL17 inhibitor, n=1,163) and 1,885 new users of apremilast.

Disclosures: The study did not receive any funding. P Claudepierre reported receiving consulting fees from and being an investigator for various pharmaceutical companies. Other authors declared no conflicts of interest.

Source: Vegas LP et al. Rheumatology. 2021 Jul 9. doi: 10.1093/rheumatology/keab522.

Key clinical point: Among patients with psoriatic arthritis (PsA), risk for major adverse cardiovascular events (MACEs) was higher in those who initiated interleukin (IL)12/23 and IL17 inhibitors vs tumor necrosis factor (TNF) inhibitors. However, risk for MACEs was not different among new-users of TNF inhibitors or apremilast.

Major finding: Overall, 51 MACEs (crude incidence rate, 3.4/1,000 patient-years) were observed. The risk of MACEs was higher (P less than .0001) with IL12/23 (weighted hazard ratio [wHR], 2.0; 95% confidence interval [CI], 1.3-3.0) and IL17 (wHR, 1.9; 95% CI, 1.2-3.0) inhibitors but not with apremilast (wHR, 1.3; 95% CI, 0.8-2.2) vs TNF inhibitors.

Study details: Findings are from a nationwide PsA cohort without a history of cardiovascular diseases involving 9,510 new users of biological disease-modifying anti-rheumatic drugs (TNF inhibitor, n=7289; IL12/23 inhibitor, n=1058; IL17 inhibitor, n=1,163) and 1,885 new users of apremilast.

Disclosures: The study did not receive any funding. P Claudepierre reported receiving consulting fees from and being an investigator for various pharmaceutical companies. Other authors declared no conflicts of interest.

Source: Vegas LP et al. Rheumatology. 2021 Jul 9. doi: 10.1093/rheumatology/keab522.

Key clinical point: The drug survival rate was good for the first biological disease-modifying antirheumatic drug (bDMARD) in patients with psoriatic arthritis (PsA). Moreover, female sex may be a predisposing risk factor for flares and therapeutic switches.

Major finding: Overall, 44.32% of patients switched to another bDMARD. The mean time to first bDMARD discontinuation was 72 months. Overall, the drug survival rate in patients treated with antitumor necrosis factor-α and anti-interleukin (IL)-12/23 or anti-IL17 was 75% at 2 years and 60% at 5 years without a significant difference between the biological agents (P = .66). Female sex was associated with a higher risk for first bDMARD discontinuation (hazard ratio, 2.39; 95% confidence interval, 1.50-3.81).

Study details: The data come from a 15-year, monocentric, real-life study involving 264 patients with PsA who received biologics treatment.

Disclosures: The study reported no external funding. R Ramonda and A Doria reported receiving honoraria and speaker fees from Novartis, AbbVie, Pfizer, MSD, and Janssen. All the other authors declared no conflicts of interest.

Source: Lorenzin M et al. Clin Rheumatol. 2021 Jun 16. doi: 10.1007/s10067-021-05799-0.

Key clinical point: The drug survival rate was good for the first biological disease-modifying antirheumatic drug (bDMARD) in patients with psoriatic arthritis (PsA). Moreover, female sex may be a predisposing risk factor for flares and therapeutic switches.

Major finding: Overall, 44.32% of patients switched to another bDMARD. The mean time to first bDMARD discontinuation was 72 months. Overall, the drug survival rate in patients treated with antitumor necrosis factor-α and anti-interleukin (IL)-12/23 or anti-IL17 was 75% at 2 years and 60% at 5 years without a significant difference between the biological agents (P = .66). Female sex was associated with a higher risk for first bDMARD discontinuation (hazard ratio, 2.39; 95% confidence interval, 1.50-3.81).

Study details: The data come from a 15-year, monocentric, real-life study involving 264 patients with PsA who received biologics treatment.

Disclosures: The study reported no external funding. R Ramonda and A Doria reported receiving honoraria and speaker fees from Novartis, AbbVie, Pfizer, MSD, and Janssen. All the other authors declared no conflicts of interest.

Source: Lorenzin M et al. Clin Rheumatol. 2021 Jun 16. doi: 10.1007/s10067-021-05799-0.

Key clinical point: The drug survival rate was good for the first biological disease-modifying antirheumatic drug (bDMARD) in patients with psoriatic arthritis (PsA). Moreover, female sex may be a predisposing risk factor for flares and therapeutic switches.

Major finding: Overall, 44.32% of patients switched to another bDMARD. The mean time to first bDMARD discontinuation was 72 months. Overall, the drug survival rate in patients treated with antitumor necrosis factor-α and anti-interleukin (IL)-12/23 or anti-IL17 was 75% at 2 years and 60% at 5 years without a significant difference between the biological agents (P = .66). Female sex was associated with a higher risk for first bDMARD discontinuation (hazard ratio, 2.39; 95% confidence interval, 1.50-3.81).

Study details: The data come from a 15-year, monocentric, real-life study involving 264 patients with PsA who received biologics treatment.

Disclosures: The study reported no external funding. R Ramonda and A Doria reported receiving honoraria and speaker fees from Novartis, AbbVie, Pfizer, MSD, and Janssen. All the other authors declared no conflicts of interest.

Source: Lorenzin M et al. Clin Rheumatol. 2021 Jun 16. doi: 10.1007/s10067-021-05799-0.

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.