Patient access to therapy Dr Lluís Puig

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1 Department of Dermatology Hospital de la Santa Creu i Sant Pau IPC NOVARTIS PSORIASIS PRECEPTORSHIP Patient access to therapy Dr Lluís Puig Barcelona, July 9th-10th, 2013

2 MSD Symposium The Overweight Pa7ent: Complexi7es in Response to Treatment. Dr. Lluís Puig. Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona. Barcelona, Catalonia, Spain.

3 BIOBADADERM comparison with data from Spanish general popula7on (INE 2009) Database: Ins7tuto Nacional de Estadís7ca (2009) NORMAL WEIGHT OVERWEIGHT OBESITY TOTAL NORMAL WEIGHT OVERWEIGHT OBESITY TOTAL Biobadaderm % ,76% ,50% ,74% ,00% Spanish popula7on % 46,34% 37,65% 16,00% 100,00% Obesity 29% Overweight 39% Normal weight 32% Obesity 16% Overweight 38% Normal weight 46% Obesity: 29 % vs 16% (p<0,001) Carrascosa JM, et al. Poster 070 3rd WPPAC, Stockholm 2012.

4 Prevalence of obesity in psoriasis OR mild psoriasis: 1.46 OR severe psoriasis: 2.23 Armstrong AW, et al. Nutr Diabetes.2012 Dec 3;2:e54

5 BMI 30 Associated With 2- Fold Increase in Risk of Psoriasis Trend in risk was significant: χ 2 =10.76, P= BMI=body mass index; OR=odds ravo. Naldi L et al. J Invest Dermatol. 2005;125:

6 Relative Risk of Psoriasis Epidemiological Rela7onship between Obesity and Psoriasis Data from the Nurses Health Study (n=880) P-value for trend < Odds Ratio for Obesity* Based on data from 409 children in 9 countries Mild Severe Overall Degree of Psoriasis Body Mass Index (BMI) *Obesity defined as BMI 85 th percentile for age Mild : Involvement of 3% of body surface area (BSA); Severe: Involvement of >3% of BSA 1. Setty AR, et al. Arch Intern Med. 2007;167: Paller AS, et al. Arch Dermatol. 2012; doi: /jamadermatol

7 eight Gain Since Age 18 Increases Rela7ve Risk of Psoriasis Weight change (lb) between age 18 and updated follow-up, pounds a Patients were followed for 14 years. A total of 892 newly diagnosed cases of psoriasis were reported. P value for trend < SeWy AR et al. Arch Intern Med. 2007;167:

8 Mean BMI, kg/m2 Psoriasis, PsA, and RA Associated With Higher BMI Compared With the General Popula7on Retrospective analysis using age- and sex-adjusted linear and regression analyses General population n=115, RA n= Psoriasis n= PsA n=644 P<0.05 for all groups except psoriasis compared with RA. PsA=psoriaVc arthrivs; RA=rheumatoid arthrivs; BMI=body mass index. a Age- and sex- adjusted differences (β coefficient) b Age- and sex- adjusted OR 95% Confidence interval in parentheses. Differences in BMI by linear regression a General populavon OR of obesity by logis7c regression b RA 1.03 (0.51, 1.55) 1.62 (1.28, 2.05) PsO 1.80 (1.34, 2.26) 1.84 (1.50, 2.26) PsA 3.39 (3.00, 3.77) 2.71 (2.31, 3.18) Bhole VM et al. Rheumatology (Oxford). 2012;51:

9 Obesity and the risk of psoria7c arthri7s: a popula7on- based study Love TJ, et al. Ann Rheum Dis 2012;71:

10 Age of Onset of PsA Correlates With BMI at Age 18 Utah Psoriasis IniVaVve (UPI) 943 subjects; 50.2% women, 49.8% men PsoriaVc arthrivs in 26.5% Mean age at the onset of: Psoriasis PsA, Risk increasing linearly over Vme Psoriasis preceded PsA in 79% of pavents; they appeared at the same Vme in 11%; and PsA preceded psoriasis in 9.9%. Soltani- Arabshahi R et al. Arch Dermatol 2010;146:

11 Obesity is a nega7ve predictor of achieving and maintaining minimal disease ac7vity (MDA) MDA was achieved by 98 (36.3%) of the 270 PsA individuals (135 obese, 135 normal weight controls). The prevalence of obesity was higher in those that did not achieve MDA than in those that did (64.0% versus 25.5%; P < 0.001). Aher adjusvng for all the other variables, obesity was associated with a higher risk of not achieving MDA (hazard ra7o [HR] 4.90, 95% confidence interval [95% CI] ; P < 0.001). The HR of not achieving MDA was 3.98 (95% CI , P < 0.001) and 5.40 (95% CI , P < 0.001) in subjects with first- degree (BMI <30) and second- degree (BMI 30-35) obesity, respecvvely. Among the 98 subjects who had achieved MDA at the 12- month follow- up, the presence of obesity was associated with a poor probability of sustained MDA at the 24- month follow- up (HR 2.04, 95% CI ; P = 0.014). Di Minno MN, et al. ArthriVs Care Res (Hoboken) Jan;65(1):141-7

12 Obesity is a nega7ve predictor of achieving and maintaining minimal disease ac7vity (MDA) MDA was achieved by 98 (36.3%) of the 270 PsA individuals (135 obese, 135 normal weight controls). The prevalence of obesity was higher in those that did not achieve MDA than in those that did (64.0% versus 25.5%; P < 0.001). Aher adjusvng for all the other variables, obesity was associated with a higher risk of not achieving MDA (hazard ra7o [HR] 4.90, 95% confidence interval [95% CI] ; P < 0.001). The HR of not achieving MDA was 3.98 (95% CI , P < 0.001) and 5.40 (95% CI , P < 0.001) in subjects with first- degree (BMI <30 ) and second- degree (BMI 30-35) obesity, respecvvely. Among the 98 subjects who had achieved MDA at the 12- month follow- up, the presence of obesity was associated with a poor probability of sustained MDA at the 24- month follow- up (HR 2.04, 95% CI ; P = 0.014). Di Minno MN, et al. ArthriVs Care Res (Hoboken) Jan;65(1):141-7

13 Therapy of psoriasis in obese pa7ents is impaired Obesity increases the risk of liver and renal toxicity to methotrexate and cyclosporin High body mass index is associated with a reduced short- term clinical response to all systemic treatments1 Biologics with a fixed- dose regimen (etanercept, adalimumab, alefacept) may have compromised efficacy in heavier individuals1,2,3 1. Naldi L, et al. Dermatology. 2008; 217: Clark L, and Lebwohl M, et al. J Am Acad Dermatol. 2008; 58: Puig L. JEADV 2012

14 High BMI May Impair Clinical Response to Systemic Treatment Na7onwide cohort analysis in Italy evaluated the effect of BMI on pa7ents receiving systemic treatments for psoriasis a OR for achieving PASI Week 8, n=2, < OR for achieving PASI Week 16, n=2, < BMI, kg/m 2 BMI, kg/m 2 a Analysis included pavents receiving cyclosporine, MTX, PUVA, and biologics. Primary end point: proporvon of pavents that achieved PASI 75 at Weeks 8 and 16. For pavents with a BMI >30: 30% decrease in response rates. 8 weeks: P=0.001 and 16 weeks: P< for BMI <20 vs 30. BMI=body mass index; OR=odds ravo; PASI=Psoriasis Area and Severity Index; MTX=methotrexate; PUVA=psoralen plus ultraviolet A. Naldi L et al. Dermatology. 2008;217:

15 Effect on Treatment: Overweight Pa7ents May Be Undertreated Overweight pavents are perceived as difficult to treat and may experience: Decreased efficacy of some biologics Increased risk of some adverse events Clinical evidence in the treatment of heavy and overweight/obese pavents is not robust. Fat cat by Eduardo Botero. Rambla del Raval, Barcelona Bremmer S et al. J Am Acad Dermatol. 2010;63:

16 Is weight reduc7on helpful in the management of psoriasis in obese pa7ents?

17 Psoriasis remission aper bariatric surgery The evidence Hossler EW, et al. The effect of weight loss surgery on the severity of psoriasis. Br J Dermatol. 2013;168: Farias MM et al. Psoriasis Following Bariatric Surgery: Clinical EvoluVon and Impact on Quality of Life on 10 pavents. Obes Surg 2012;22: Hossler EW et al. Gastric bypass surgery improves psoriasis. J Am Acad Dermatol 2011;65: Pérez- Pérez L et a. Severe psoriasis, morbid obesity and bariatric surgery. Clin Exp Dermatol 2009;34:e de Menezes Etnger JE et al. Remission of psoriasis aher open gastric bypass. Obes Surg 2006;16:94-7. Higa- Sansone G et al. Psoriasis remission aher laparoscopic Roux- en- Y gastric bypass for morbid obesity. Obes Surg 2004;16:

18 Weight loss improves the response of obese pa7ents with moderate- to- severe chronic plaque psoriasis to low- dose cyclosporine therapy PASI (mean ± SD) * * * * * Body weight (kg; mean ± SD) * * * * * Months CSA + Diet 60 0 CSA Months *p<0.001 (Cochran- Mantel- Haenszel analysis). Differences in mean values of PASI and body weight along Vme were evaluated using mixed effects regression models for longitudinal data. A significant Vme by treatment interacvon was found for PASI (p<0.001). Also, when body weight was considered, a significant Vme- by- treatment interacvon was found (p<0.001). Subjects who underwent a low- calorie diet showed a significant reducvon in mean body weight up to 4 months; in the cyclosporine alone group body weight was fairly stable during the period considered. Gisondi P, et al. Am J Clin Nutr. 2008; 88:

19 Effect of Weight Loss on the Severity of Psoriasis (Treatment Unchanged) 60 of 69 eligible overweight pavents with psoriasis (BMI, 27-40; aged years). Interven7ons: The intervenvon group received a low energy diet (LED) ( kcal/d) for 8 weeks to induce weight loss, followed by 8 weeks of reintroducvon of normal food intake, reaching 1200 kcal/d. Jensen P, et al. JAMA Dermatol May 29:1-7

20 DiMinno MN, et al. Ann Rheum Dis Jun 14. Weight loss and achievement of MDA in pa7ents with psoria7c arthri7s star7ng treatment with TNFα blockers 5% weight loss in 74 (58.7%) subjects; 10% weight loss in 26 (20.6%); the remaining 52 subjects experiencing a <5% weight loss (n=41) or 2 kg weight gain (n=11). MDA was more ohen achieved by HD than by FD subjects (HR=1.85, 95% CI to 3.345, p=0.043). N= % 59.5% 23.1% Regardless of the type of diet, aher 6 months of treatment with TNFα blockers, 5% of weight loss was a predictor of the achievement of MDA (OR=4.20, 95% CI 1.82 to 9.66, p<0.001), but not in those with the peripheral subset (OR=1.94, 95% CI 0.25 to 15.1, p=0.525).

21 Predictors of Primary Failure (PGA >2) of Etanercept At 50 mg biw for 12 weeks, 170 of 347 pavents (49%) achieved PGA <2. 50 of 177 (28%) did not achieve PGA <3 (nonresponders) and received ustekinumab 90 mg at Weeks 16 and 20. Baseline features associated with nonresponse: Male sex (76.0% vs 70.8%) Heavier (99.3 kg vs 89.4 kg) PGA >3 (marked or severe): 64.0% vs 39.2% Prior biologic treatment: 26.0% vs 9.4% Lack of response, intolerance, or contraindicavon to at least 2 (EMA label: 64.0% vs 51.0%) or 3 (30.0% vs 13.1%) convenvonal systemic treatments PGA=Physician s Global Assessment; EMA=European Medicines Agency. Griffiths CE et al. J Am Acad Dermatol. 2010;62(suppl 1):AB137.

22 Efficacy of Salvage Biologic Treatments in Pa7ents Without Primary Response to Etanercept Ustekinumab 90 mg achieved PGA of 0 to 1 in 40% of pa7ents. 1 Adalimumab achieved PGA of 0 to 1 in 49% of pa7ents. 2 Infliximab achieved PGA of 0 to 1 in 65% of pa7ents and PASI 75 response in 55% of pa7ents Pa7ents achieving PGA of 0 to 1, % Apparently bewer (no head- to- head trials): might this be related to weight- based dosing? 0 Ustekinumab Adalimumab Infliximab PGA=Physician s Global Assessment; PASI=Psoriasis Area and Severity Index. 1. Griffiths CE et al. J Am Acad Dermatol. 2010;62(suppl 1):AB Strober B et al. J Am Acad Dermatol. 2010;62(suppl 1):AB Gowlieb AB et al. J Am Acad Dermatol. 2010;62(suppl 1):AB133.

23 The Effect of Infliximab is Independent of BMI Patients achieving PASI 75, % n= Integrated subgroup analysis of 3 clinical trials (N=1,462) a Normal (BMI <25) Overweight (BMI 25 to <30) Obese (BMI 30) Placebo Combined infliximab groups a Analysis of 3 placebo- controlled clinical trials (SPIRIT, EXPRESS, EXPRESS II). The common primary end point was the proporvon of pavents that achieved PASI 75 at Week 10. BMI=body mass index; PASI=Psoriasis Area and Severity Index; SPIRIT=Study of Psoriasis with Infliximab (REMICADE) InducVon Therapy; EXPRESS=European Infliximab for Psoriasis (Remicade ) Efficacy and Safety Study; EXPRESS II=EvaluaVon of Infliximab for Psoriasis in a Remicade Efficacy and Safety Study. Reich K et al. Psoriasis Forum. 2007;13:

24 Efficacy of Adalimumab Versus Etanercept Stratified by Weight. A subanalysis of data from REVEAL, CHAMPION, M10-114, and M ADA- treated pa7ents had significantly greater odds of achieving PASI 50, PASI 75, and PASI 90 than ETN- treated pa7ents. Adjusted chance of specified outcome ADA- treated pa7ents <100 kg ADA- treated pa7ents 100 kg PASI 50 PASI 75 PASI 90 Analysis was restricted to pavents with nonmissing values for PASI and DLQI. Adjusted efficacy refers to a least- squares (LS) means adjusted mulvvariate regression model, controlling for age, baseline BSA, DLQI, PASI, sex, biologic systemic use, nonbiologic systemic use, history of comorbidives, and symptomavc comorbidives. Missing values were imputed using the last- observavon- carried forward method. Sample was restricted to pavents with nonmissing baseline values and 1 nonmissing study values during the double- blind period. Sutdy period defined as Weeks Armstrong AW, et al. P th Annual Mee7ng of the American Academy of Dermatology, San Diego, CA, March

25 Efficacy of Adalimumab Versus Etanercept Stratified by Weight. A subanalysis of data from REVEAL, CHAMPION, M10-114, and M ADA- treated pa7ents had significantly greater odds of achieving PASI 50, PASI 75, and PASI 90 than ETN- treated pa7ents. Adjusted chance of specified outcome ADA- treated pa7ents <100 kg ETN- treated pa7ents <100 kg ADA- treated pa7ents 100 kg PASI 50 PASI 75 PASI 90 ETN- treated pa7ents 100 kg Analysis was restricted to pavents with nonmissing values for PASI and DLQI. Adjusted efficacy refers to a least- squares (LS) means adjusted mulvvariate regression model, controlling for age, baseline BSA, DLQI, PASI, sex, biologic systemic use, nonbiologic systemic use, history of comorbidives, and symptomavc comorbidives. Missing values were imputed using the last- observavon- carried forward method. Sample was restricted to pavents with nonmissing baseline values and 1 nonmissing study values during the double- blind period. Sutdy period defined as Weeks Armstrong AW, et al. P th Annual Mee7ng of the American Academy of Dermatology, San Diego, CA, March

26 Efficacy of Adalimumab Versus Etanercept Stratified by Weight. A subanalysis of data from REVEAL, CHAMPION, M10-114, and M ADA- treated pa7ents had significantly greater odds of achieving PASI 50, PASI 75, and PASI 90 than ETN- treated pa7ents. Adjusted chance of specified outcome ADA- treated pa7ents <100 kg ETN- treated pa7ents <100 kg PASI 75 PASI 90 ADA- treated pa7ents 100 kg ETN- treated pa7ents 100 kg Analysis was restricted to pavents with nonmissing values for PASI and DLQI. Adjusted efficacy refers to a least- squares (LS) means adjusted mulvvariate regression model, controlling for age, baseline BSA, DLQI, PASI, sex, biologic systemic use, nonbiologic systemic use, history of comorbidives, and symptomavc comorbidives. Missing values were imputed using the last- observavon- carried forward method. Sample was restricted to pavents with nonmissing baseline values and 1 nonmissing study values during the double- blind period. Study period defined as Weeks Armstrong AW, et al. P th Annual Mee7ng of the American Academy of Dermatology, San Diego, CA, March

27 Subanalysis of BELIEVE: PASI 75 at Week 16 by History of PsA and Baseline Weight Status Patients achieving PASI 75, % kg >71 to 84 kg >84 to 95 kg >95 kg Pa7ents with PsA Pa7ents without PsA ITT popula7on; nonresponder imputa7on. P values for pa7ents with PsA vs pa7ents without PsA: <71 kg, P=0.746; >71 to 84 kg, P=0.476; >84 to 95 kg, P=0.104; >95 kg, P= PASI=Psoriasis Area and Severity Index; PsA=psoria7c arthri7s; ITT=intent to treat. PASI 75 response rates in patients without a history of PsA were numerically higher than those with a history of PsA in each weight quartile. By history of PsA, patients in the highest weight quartile (>95 kg) had lower PASI response rates than those in the lower weight quartiles ( 95 kg). Paul C, et al. 70th Annual Meeting of the American Academy of Dermatology; March 2012; San Diego, CA, USA.

28 Ustekinumab vs Etanercept (ACCEPT) PASI 75 Response Rates at Week 12 According to Baseline Weight ACCEPT 100 kg >100 kg Patients, % Patients, % Etanercept (n=251) Ustekinumab 45 mg (n=151) Ustekinumab 90 mg (n=244) 0 Etanercept (n=96) Ustekinumab 45 mg (n=58) Ustekinumab 90 mg (n=103) hwp:// _Product_Informa7on/human/000958/WC pdf. 47

29 Etanercept in Heavy- Weight Psoriasis Pa7ents Integrated, multistudy, post hoc analysis; N=1,187 a 60 P< PASI 75, % P< <89.36 kg kg Placebo n=414 Etanercept 50 mg weekly n=415 Etanercept 50 mg twice weekly n=358 a Analysis of 3 randomized, placebo- controlled trials evaluavng the efficacy of etanercept in pavents with psoriasis. The primary end point for these studies was the proporvon of pavents that achieved 75% improvement in PASI response from baseline at Week 12. PASI=Psoriasis Area and Severity Index. Gordon K et al. J Am Acad Dermatol. 2006;54:S101 S

30 Drug pharmacokine7cs are likely to be relevant! Adalimumab drug levels at 4 weeks predict responder status at 6 months with low or absent levels associated with failure to achieve PASI 50 AnV- adalimumab anvbodies are associated with non- response. Mahil SK, et al. Br J Dermatol Mar 29.

31 Is High Weight a Predictor of Poor Response to Ustekinumab? Ustekinumab pharmacokine7c analysis of pa7ents >100 kg from PHOENIX 1 and 2 Apparent Volume of Distribution of UST by Body Weight >100 kg vs 100 kg 30% decrease in steady-state trough serum concentrations 55% increase in apparent drug clearance 37% higher apparent volume of distribution N=1,937. PHOENIX=Psoriasis Followed by Long- Term Extension. Zhu Y et al. J Clin Pharmacol. 2009;49:

32 Ustekinumab in Higher- Weight Pa7ents Integrated subgroup post hoc analysis (N=1,996) a P<0.0001; 20% difference PASI 75 at Week 28, % n= kg >100 kg 74 Ustekinumab 45 mg Ustekinumab 90 mg a Phase 3, randomized, controlled analysis of pooled data from PHOENIX 1 and 2. PASI=Psoriasis Area and Severity Index; PHOENIX=Psoriasis Followed by Long-Term Extension. Lebwohl M et al. J Am Acad Dermatol. 2010;63:

33 Ustekinumab vs Etanercept (ACCEPT) PASI 75 Response Rates at Week 12 According to Baseline Weight ACCEPT 100 kg >100 kg Patients, % Patients, % Etanercept (n=251) Ustekinumab 45 mg (n=151) Ustekinumab 90 mg (n=244) 0 Etanercept (n=96) Ustekinumab 45 mg (n=58) Ustekinumab 90 mg (n=103) hwp:// _Product_InformaVon/human/000958/WC pdf. 52

34 Lebwohl M et al. J Am Acad Dermatol. 2010;63:571-9

35 Es7mates of PASI 75 Response Rates at Week 12 Decrease as Weight Increases Ustek docket b1-01- FDA

36 100- kg Cut- off Might Be Inadequate PASI 75 according to weight following 16 weeks of ustekinumab PASI 75, % < >110 Weight, kg 90 mg Laws PM et al. Br J Dermatol Sep 20.

37 Drug survival according to BMI (BIOBADADERM) Survival of biologic drug due to inefficacy or loss of efficacy : Log Rank test according to BMI group p= 0.04* Normal Overweight Obese Carrascosa JM, et al. Poster 070 3rd WPPAC, Stockholm RR of disconvnuavon associated to each 5 units increase in BMI: 1.14 (95%CI )

38

39 Effect of Biologic Treatment on Weight All 230 pa7ents received treatment 48 weeks. Mean baseline weight 80 kg (M+F) 44,6% of an7- TNF treated put on weight (5 kg average?). Not in pa7ents treated with MTX or efalizumab Etanercept > IFX or ADA, lean > obese. Weight gain remained beyond 48 weeks (decreased in IFX or ADA pa7ents) % of pavents 100% 80% 60% 40% >10% 5-10% <5% % 0% Saraceno R, et al. Pharmacol Res. 2008;57: etanercept 44% adalimumab 40% infliximab 48%

40 An7- TNF Treatment Increases Body Weight Body weight increased in increments of 1.5 ± 2.7 kg (mean ± SD; P=0.0002) and 2.5 ± 3.3 kg (P=0.004) in pavents treated with etanercept and infliximab, respecvvely. No significant change (0.6 ± 1.4 kg; P=0.4) was measured in pavents treated with methotrexate. Body mass index increased by 0.5 ± 0.5 point (P=0.01) and 0.8 ± 1 point (P=0.003) in pavents treated with etanercept and infliximab, respecvvely. No change (<0.2 ± 0.5; P=0.06) was noted in pavents treated with methotrexate. About one- fourth of pa7ents experienced weight gain of 4 to 10 kg. TNF=tumor necrosis factor. Gisondi P et al. J Eur Acad Dermatol Venereol. 2008;22:

41 An7- TNF Treatment Is Associated With Increased Body Weight Aper 24 Weeks in Pa7ents With Pso (75%) and PsA (60%) Patients, % Increased weight Unchanged weight Decreased weight Pso PsA Body weight changes in Pso and PsA pavents aher anv- TNF therapy. Each group was subdivided depending on the percentage of pavents with increased, unchanged, or decreased weight with respect to the baseline (Pso: n=20; PsA: n=20). TNF=tumor necrosis factor; Pso=psoriasis; PsA=psoriaVc arthrivs. Renzo LD et al. Dermatol Ther. 2011;24:

42 Florin V et al. 23 May J Eur Acad Dermatol Venereol. doi: /j x. Effect of Infliximab Treatment: Weight Gain Larger in Nonobese Pa7ents BMI <25 kg/m 2 BMI 25 kg/m 2 between groups n Weight gain at 1 year, kg Weight Gain in Pa7ents Treated With IFX as a Func7on of BMI Change in body weight at 1 year (mean), % EffecVve aher 1 year of treatment 4 ( 4, 10) 1.3 ( 8, 10) a +6.4 ( 5.3, 17.3) +1.2 ( 8.1, 8.9) a PASI (81.2%) 15 (78.9%) : differences; a P<0.05. Percent weight increase from baseline IFX=infliximab; BMI=body mass index; PASI=Psoriasis Area and Severity Index Control IFX n= Differential percent weight increase from baseline after 1 year in control (MTX-, cyclosporine-, or acitretin-treated) patients, normal-weight IFX-treated patients, and overweight IFX-treated patients. *P=0.008 between IFX-treated BMI groups. * BMI <25 BMI >25

43 Infliximab and weight gain MulVcentric French study:191 pavents treated with infliximab for at least one year. Nearly 50% of them suffered from weight gain (>2% above baseline); their mean weight change was 7.8%, and in 10% the weight increment was 10% or more. Male sex, psoriasis severity and low baseline BMI were associated with greater weight increment on univariate analysis, whereas dietary management during infliximab treatment and simultaneous methotrexate intake provided protec7on against weight gain on mul7variate analysis. Mahé E, et al. J Eur Acad Dermatol Venereol Dec 28. doi: /jdv

44 Ustekinumab does not increase body mass index in pa7ents with chronic plaque psoriasis: a prospec7ve cohort study A prospecvve, mulvcenter study: 7- month treatment with ustekinumab (n=79) or infliximab (n=83). Patients treated with infliximab showed a significant (p< 0.001) increase in BMI (2.1%±4.5, mean ± SD) and body weight (+2.5±3.3 kg) compared to patients treated with ustekinumab (0.1%±3.3; 0.6 Kg±1.1). 45% of patients treated with infliximab had a BMI increase greater 2% compared to only 11% of those receiving ustekinumab (p=0.01). Gisondi P, et al. Br J Dermatol Jan 16.