Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a ≥ 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a ≥ 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, ≥ 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a ≥ 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, ≥ 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a ≥ 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, ≥ 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

TOPLINE:

The Fracture Risk Assessment Tool (FRAX), with bone mineral density, predicts the risk for major osteoporotic fractures and hip fractures in patients with cancer, but FRAX without bone mineral density slightly overestimates these risks, a new analysis found.

METHODOLOGY:

• Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
• This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
• Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
• Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).

TAKEAWAY:

• Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
• FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
• In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
• When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.

IN PRACTICE:

“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.

SOURCE:

This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.

LIMITATIONS:

This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.

DISCLOSURES:

This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The Fracture Risk Assessment Tool (FRAX), with bone mineral density, predicts the risk for major osteoporotic fractures and hip fractures in patients with cancer, but FRAX without bone mineral density slightly overestimates these risks, a new analysis found.

METHODOLOGY:

• Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
• This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
• Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
• Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).

TAKEAWAY:

• Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
• FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
• In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
• When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.

IN PRACTICE:

“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.

SOURCE:

This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.

LIMITATIONS:

This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.

DISCLOSURES:

This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The Fracture Risk Assessment Tool (FRAX), with bone mineral density, predicts the risk for major osteoporotic fractures and hip fractures in patients with cancer, but FRAX without bone mineral density slightly overestimates these risks, a new analysis found.

METHODOLOGY:

• Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
• This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
• Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
• Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).

TAKEAWAY:

• Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
• FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
• In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
• When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.

IN PRACTICE:

“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.

SOURCE:

This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.

LIMITATIONS:

This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.

DISCLOSURES:

This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.