Psoriatic Arthritis

Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).

Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).

Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.

Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.

Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source

Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).

Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).

Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.

Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.

Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source

Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).

Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).

Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.

Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.

Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source

Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).

Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).

Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.

Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.

Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source

Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).

Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).

Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.

Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.

Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source

Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).

Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).

Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.

Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.

Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source

Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.

Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).

Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.

Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.

Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol.  2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source

Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.

Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).

Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.

Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.

Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol.  2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source

Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.

Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).

Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.

Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.

Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol.  2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source

Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).

Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).

Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source

Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).

Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).

Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source

Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).

Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).

Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source

Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.

Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.

Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).

Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.

Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.

Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.

Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).

Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.

Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.

Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.

Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).

Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.

Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source

Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.

Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.

Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.

Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.

Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source

Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.

Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.

Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.

Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.

Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source

Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.

Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.

Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.

Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.

Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source

Key clinical point: Switching between biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) was common due to treatment inefficacy in patients with psoriatic arthritis (PsA), with concomitant therapies and multiple prior treatments being significant risk factors.

Major finding: Overall, 40% of patients switched between b/tsDMARD, with 85.1% switches due to treatment inefficacy. The risk for switching was not affected by b/tsDMARD type (P > .05) but increased with multiple b/tsDMARD courses (adjusted hazard ratio [aHR] 1.22; P = .010), concomitant glucocorticoids (aHR 2.05; P = .001), and sulfalazine use (aHR 2.25; P = .006). Women and those with inflammatory back pain also faced an increased risk for switching.

Study details: This longitudinal retrospective study included 141 patients with PsA (age ≥ 16 years) who were treated with b/tsDMARD.

Disclosures: This study was supported by the Instituto de Salud Carlos III, Ministry of Health, Spain, and Red de Enfermedades Inflamatorias, with co-funding from el Fondo Europeo de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Freites-Nuñez D, Leon L, Toledano E, et al. Switching related to inefficacy in biologics and targeted synthetic therapies for psoriatic arthritis: A comparative real-life study. Ther Adv Musculoskelet Dis. 2024 (Aug 31). doi:10.1177/1759720X241273083 Source

Key clinical point: Switching between biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) was common due to treatment inefficacy in patients with psoriatic arthritis (PsA), with concomitant therapies and multiple prior treatments being significant risk factors.

Major finding: Overall, 40% of patients switched between b/tsDMARD, with 85.1% switches due to treatment inefficacy. The risk for switching was not affected by b/tsDMARD type (P > .05) but increased with multiple b/tsDMARD courses (adjusted hazard ratio [aHR] 1.22; P = .010), concomitant glucocorticoids (aHR 2.05; P = .001), and sulfalazine use (aHR 2.25; P = .006). Women and those with inflammatory back pain also faced an increased risk for switching.

Study details: This longitudinal retrospective study included 141 patients with PsA (age ≥ 16 years) who were treated with b/tsDMARD.

Disclosures: This study was supported by the Instituto de Salud Carlos III, Ministry of Health, Spain, and Red de Enfermedades Inflamatorias, with co-funding from el Fondo Europeo de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Freites-Nuñez D, Leon L, Toledano E, et al. Switching related to inefficacy in biologics and targeted synthetic therapies for psoriatic arthritis: A comparative real-life study. Ther Adv Musculoskelet Dis. 2024 (Aug 31). doi:10.1177/1759720X241273083 Source

Key clinical point: Switching between biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) was common due to treatment inefficacy in patients with psoriatic arthritis (PsA), with concomitant therapies and multiple prior treatments being significant risk factors.

Major finding: Overall, 40% of patients switched between b/tsDMARD, with 85.1% switches due to treatment inefficacy. The risk for switching was not affected by b/tsDMARD type (P > .05) but increased with multiple b/tsDMARD courses (adjusted hazard ratio [aHR] 1.22; P = .010), concomitant glucocorticoids (aHR 2.05; P = .001), and sulfalazine use (aHR 2.25; P = .006). Women and those with inflammatory back pain also faced an increased risk for switching.

Study details: This longitudinal retrospective study included 141 patients with PsA (age ≥ 16 years) who were treated with b/tsDMARD.

Disclosures: This study was supported by the Instituto de Salud Carlos III, Ministry of Health, Spain, and Red de Enfermedades Inflamatorias, with co-funding from el Fondo Europeo de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Freites-Nuñez D, Leon L, Toledano E, et al. Switching related to inefficacy in biologics and targeted synthetic therapies for psoriatic arthritis: A comparative real-life study. Ther Adv Musculoskelet Dis. 2024 (Aug 31). doi:10.1177/1759720X241273083 Source

Key clinical point: Patients with early oligoarticular psoriatic arthritis (PsA) treated with apremilast vs placebo showed greater disease control and minimal disease activity response with a maximum of one swollen joint and one tender joint count (MDA-Joints).

Major finding: At week 16, a higher proportion of patients receiving apremilast vs placebo achieved MDA-Joints response based on sentinel joints (33.9% vs 16.0%; P = .0008) and total joints (21.3% vs 7.9%; nominal P = .0028). No new safety signals were reported.

Study details: This phase 4 FOREMOST trial included 308 patients with early oligoarticular PsA previously treated with non-steroidal anti-inflammatory drugs or ≥2 conventional synthetic disease-modifying antirheumatic drugs and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).

Disclosures: This study was funded by Amgen. Five authors declared being employees and owning stocks of Amgen. Several authors have declared other ties with Amgen and other sources.

Source: Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: Primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 (Aug 20). doi: 10.1136/ard-2024-225833 Source

Key clinical point: Patients with early oligoarticular psoriatic arthritis (PsA) treated with apremilast vs placebo showed greater disease control and minimal disease activity response with a maximum of one swollen joint and one tender joint count (MDA-Joints).

Major finding: At week 16, a higher proportion of patients receiving apremilast vs placebo achieved MDA-Joints response based on sentinel joints (33.9% vs 16.0%; P = .0008) and total joints (21.3% vs 7.9%; nominal P = .0028). No new safety signals were reported.

Study details: This phase 4 FOREMOST trial included 308 patients with early oligoarticular PsA previously treated with non-steroidal anti-inflammatory drugs or ≥2 conventional synthetic disease-modifying antirheumatic drugs and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).

Disclosures: This study was funded by Amgen. Five authors declared being employees and owning stocks of Amgen. Several authors have declared other ties with Amgen and other sources.

Source: Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: Primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 (Aug 20). doi: 10.1136/ard-2024-225833 Source

Key clinical point: Patients with early oligoarticular psoriatic arthritis (PsA) treated with apremilast vs placebo showed greater disease control and minimal disease activity response with a maximum of one swollen joint and one tender joint count (MDA-Joints).

Major finding: At week 16, a higher proportion of patients receiving apremilast vs placebo achieved MDA-Joints response based on sentinel joints (33.9% vs 16.0%; P = .0008) and total joints (21.3% vs 7.9%; nominal P = .0028). No new safety signals were reported.

Study details: This phase 4 FOREMOST trial included 308 patients with early oligoarticular PsA previously treated with non-steroidal anti-inflammatory drugs or ≥2 conventional synthetic disease-modifying antirheumatic drugs and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).

Disclosures: This study was funded by Amgen. Five authors declared being employees and owning stocks of Amgen. Several authors have declared other ties with Amgen and other sources.

Source: Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: Primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 (Aug 20). doi: 10.1136/ard-2024-225833 Source

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

A version of this article first appeared on Medscape.com.

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

A version of this article first appeared on Medscape.com.

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

A version of this article first appeared on Medscape.com.

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

A version of this article first appeared on Medscape.com.

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

A version of this article first appeared on Medscape.com.

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

A version of this article first appeared on Medscape.com.