scholarly journals Life-Threatening Adverse Reaction after Self-Initiated, Off-Label Use of High Dose Nicotinamide for the Treatment of Friedreich’s Ataxia

2015 ◽  
Vol 2 (3) ◽  
Author(s):  
Nicolas Garin ◽  
Pierre Arnold
Keyword(s):  
Adverse Reaction ◽  
Friedreich’S Ataxia ◽  
Friedreich's Ataxia ◽  
High Dose ◽  
Off Label Use ◽  
Off Label ◽  
Life Threatening ◽  
Label Use

Subcutaneous Alemtuzumab Combined with Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allo-SCT In CLL with 17p- or Refractory to Fludarabine – Interim Analysis of the CLL2O Trial of the GCLLSG and FCGCLL/MW

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 920-920 ◽  
Author(s):  
Stephan Stilgenbauer ◽  
Florence Cymbalista ◽  
Véronique Leblond ◽  
Alain Delmer ◽  
Thorsten Zenz ◽  
...  
Keyword(s):  
Disease Progression ◽  
Board Of Directors ◽  
Research Funding ◽  
Remission Rate ◽  
High Dose ◽  
Off Label Use ◽  
Advisory Committees ◽  
Off Label ◽  
Oral Dexamethasone ◽  
Label Use

Abstract Abstract 920 CLL refractory to purine analogues (e.g. fludarabine, F) or with 17p- is associated with very poor prognosis. Alemtuzumab is active in F-refractory CLL, and has proven efficacy in patients (pts) with 17p-. However, outcome of F-refractory CLL is still poor in terms of remission rate and duration of remission. The multinational, multicenter CLL2O trial aims at achieving a higher remission rate by adding high-dose dexamethasone to alemtuzumab, and prolongation of remission duration and survival by alemtuzumab maintenance or allogeneic stem-cell transplantation (allo-SCT). Pts with CLL refractory (no PR/CR or PR/CR < 6 months) to F-based (e.g. FR, FC, FCR) or similar chemotherapy (i.e. pentostatin, cladribine, bendamustine), or exhibiting 17p- (untreated or at relapse) were eligible if they had “active disease”. Treatment was with subcutaneous alemtuzumab 30 mg weekly × 3 for 28 days, combined with oral dexamethasone 40 mg on days 1–4 and 15–18, and prophylactic pegfilgrastim 6 mg days 1 and 15. Depending on the remission status, pts were treated for up to 12 weeks. If CR was documented at 4 or 8 weeks, or at least SD was achieved at 12 weeks, consolidation was scheduled with either allo-SCT or alemtuzumab maintenance with 30mg weekly every 14 days for up to 2 years (yrs). Decision for one of the two consolidation options was at discretion of patient and physician. From January 2008 to July 2010, 80 pts were enrolled at 22 centers and 79 were eligible; F-refractory (n=31), 17p- without prior therapy (n=31), and 17p- in relapse (n=17). Median age was 65 yrs in the F-refractory (range 38–76) and 17p- 1st-line group (36-76), and 60 yrs for the 17p- relapse group (54-73) with male predominance (F-refractory 74%, 17p- 1st-line 71%, 17p- relapse 82%). In the 17p- 1st-line and relapse groups, 52% and 50% were stage Binet C and exhibit reduced performance status (ECOG 1–2), compared to 81% Binet C and 60% ECOG 1–2 for the F-refractory cohort. Pretreated pts had received a median of 2 prior lines (F-refractory 1–6; 17p- relapse 1–5), and 5 pts had received prior SCT. In the F-refractory group, 16% of pts had 11q- and 52% had 17p-. IGHV was unmutated in 64% of 17p- groups and 72% in the F-refractory group. The median levels of ß2-MG / TK were 4.35 / 35.40 in the 17p- groups and 4.12 / 22.65 in the F-refractory group. Treatment data are currently available for 50 pts who completed induction therapy; F-refractory (n=19),17p- 1st-line (n=22), 17p- relapse (n=9). Full treatment duration (12 weeks) could be achieved in 47% F-refractory, 67% 17p- relapsed and 82% 17p- 1st-line pts. In the latter cohort, early stop of therapy was mainly correlated with CR, while in the F-refractory cohort with disease progression (n=2) and infections (n=5, 4 with no documented response). Response rates (ORR / CR) were 47% / 0% in the F-refractory cohort, 78% / 0% in the 17p- relapsed, and 100% / 23% in the 17p- 1st-line cohorts (as compared to this, ORR / CR was 71.4% / 4.8% with FCR in the 17p- 1st-line group of CLL8). Adverse events during treatment were mostly grade 1/2 apart from hematotoxicity. Grade 3/4 non-CMV infection occurred in 35% of F-refractory, 12% of 17p- relapsed, and 16% of 17p- 1st-line pts. CMV reactivation was observed in 32 % of the 17p- 1st-line pts, and less for the pretreated groups (F-refractory 16%, 17p- relapsed 18%). All CMV episodes were successfully treated, and there was no CMV-related death. Among 18 pts documented to receive alemtuzumab maintenance treatment, so far 3 SAEs have been reported: ITP (n=1, twice in the same pt), and fever / diarrhea / thyroiditis (n=1). At a median follow-up of 41.9 weeks (maintenance 54.7 weeks, allo-SCT 29 weeks), there were 7 (37%) deaths in the in the F-refractory cohort, 2 due to disease progression, and 5 due to infection. For the 17p- relapsed group, 3 progressions and 3 deaths were reported, with one case in each treatment option (SCT/maintenance), and one pt in salvage therapy. In the 17p- 1st-line cohort, 4 progressions occurred, 2 pts died, both in maintenance therapy. At 12 months, estimated overall survival was 54%, 66% and 100% in the F-refractory, 17p- relapse, and 17p- 1st-line cohorts, respectively. Accrual is currently ongoing with a target enrolment of 122 pts and updated results will be presented at the meeting. Disclosures: Stilgenbauer: Amgen: Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Genzyme: Consultancy, Honoraria, Research Funding; GSK: Consultancy, Honoraria, Research Funding; Mundipharma: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Sanofi Aventis: Research Funding. Off Label Use: off-label use of diagnostic tests and therapeutic agents. Leblond:ROCHE: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MUNDIPHARMA : Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CELGENE: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Zenz:Roche: Honoraria; Boehringer: Honoraria; GSK: Honoraria; Celgene: Honoraria. Choquet:ROCHE : Consultancy. Hallek:Roche: Honoraria, Research Funding. Döhner:Pfizer: Research Funding.

73 Off-label use and safety of drug use in vascular anomalies

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e53-e55
Author(s):  
Laurence Gariépy-Assal ◽  
Simon Marcoux ◽  
Jerome Coulombe ◽  
Julie Powell ◽  
Sandrine Essouri ◽  
...  
Keyword(s):  
Drug Use ◽  
Vascular Anomalies ◽  
Abnormal Development ◽  
Off Label Use ◽  
Significant Safety ◽  
Off Label ◽  
Safety Concerns ◽  
Increased Risk ◽  
Life Threatening ◽  
Label Use

Abstract Primary Subject area Clinical Pharmacology and Toxicology Background Vascular anomalies (VA) represent a heterogeneous group of disorders associated with an abnormal development and proliferation of blood and/or lymphatic vessels displaying variable clinical presentations and severity. Infantile hemangiomas, venous, and lymphatic malformations, for example, are commonly encountered in children. Other, less frequent diagnostics include Klippel-Trenaunay syndrome and PIK-3CA-related overgrowth spectrum (PROS). Severe phenotypes can alter organ function and/or lead to pain and chronic functional impairment, and are associated with significant morbidity and mortality. Management includes surgical, interventional radiology, and pharmacologic modalities. Drugs are administered by systemic (e.g., oral, intravenous) or local (topical, intralesional) routes, or by sclerotherapy (endovascular or percutaneous venous, lymphatic, or arterial injection). Off-label drug use is common in pediatrics and in rare diseases, two characteristics applying to vascular anomalies (VA). Off-label use is associated with an increased risk of adverse drug reactions. Objectives To quantify off-label drug use in VA and assess its safety. Design/Methods A guidelines search was conducted to extract a list of drugs used in VA management. The labelling status and safety of each drug was assessed based on the product monograph, Micromedex, and the FDA data. A drug was considered to have significant safety concerns if a black box warning (the FDA’s most stringent warning dedicated to serious or life-threatening risks) or if a serious adverse drug reaction was reported in at least 1% of the patients (leading to hospitalization, congenital malformation, persistent or significant disability or incapacity, life-threatening condition, or death). Results Among 87 drugs, 13 were unlicensed and 73 off-label. Figure 1 describes the reason for considering the 73 drugs off-label. Among 74 licensed drugs, only the oral solution of propranolol hydrochloride (Hemangeol®) for the treatment of infantile hemangiomas (IH) is approved. 98.9% of the drugs are used off-label or unlicensed. Except infantile hemangioma, all other VA are exclusively treated with off-label drugs. Significant safety issues concerned 73% of the drugs and were more frequent among systemic than locally delivered drugs (Figure 2). Conclusion This first study determining the rate of off-label drug use in vascular anomalies shows that off-label drug use in VA is the rule and not the exception. Significant safety concerns are common. It is needed to carefully weigh risk and benefits for every patient when using systemic and local treatments carrying safety concerns. Patients and families should be openly informed and involved in the decision-making process.

High-dose antihistamines for chronic spontaneous urticaria in adults

2018 ◽  
Vol 56 (4) ◽  
pp. 45-48
Keyword(s):  
Skin Disease ◽  
Second Generation ◽  
Chronic Spontaneous Urticaria ◽  
High Dose ◽  
Off Label Use ◽  
Off Label ◽  
Common Skin ◽  
Label Use

Chronic spontaneous urticaria (CSU) is a common skin disease characterised by intermittent weals (hives), angioedema or both lasting for at least 6 weeks.1-3 Second-generation antihistamines are widely used to manage symptoms but are not completely effective in many patients at licensed doses.4 Some guidelines recommend off-label use of high-dose antihistamines as the next therapeutic step.2,3 Here, we review the evidence supporting this recommendation.

Using Recombinant Activated Factor VII (rFVIIa) in Refractory Bleeding: A Community Hospital Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4048-4048
Author(s):  
Alaa Muslimani ◽  
Hamed Daw
Keyword(s):  
Multiple Myeloma ◽  
Blood Loss ◽  
Blood Cell ◽  
Red Blood Cell ◽  
Transfusion Requirement ◽  
Factor Vii ◽  
Off Label Use ◽  
Off Label ◽  
Life Threatening ◽  
Label Use

Abstract Introduction: Recently, there has been an increase in using rFVIIa for uncontrolled bleeding in non hemophilic patients. While evidence-based guidelines exist for using rFVIIa in hemophilia, none are available for its off-label use. We report four cases who were treated with rFVIIa for massive uncontrolled hemorrhage. Method: Four [3 female (F) and one male (M)] critically ill patients with a median age of 59.25 years (range 49–78) exhibiting massive, life-threatening bleeding were treated with rFVIIa after conventional therapy [transfusion of fresh frozen plasma (FFP), red blood cell (RBC), platelet (Plt) and cryopreciptate (cryo)] had failed to control the blood loss. The starting dose was 90 μg/kg. If there was no response within 20 minutes, a second dose of 90 μg/kg was given. The median rFVIIa number of treatments were 4 (range 1–8). Treatment efficacy was evaluated after each dose and was based on : the amount of hemorrhage judged visually, and the number of red blood cell units required to maintain a stable hemoglobin level of &gt; 8g/dl. Clinical response was rated as complete (no transfusion requirement, or change from severe to minor type of bleeding), partial (decrease of hemorrhage from severe to moderate), or failure (no change of hemorrhage and/or no change in transfusion requirement). rFVIIa was given in conjunction with transfusion of packed RBC in order to avoid further loss of clotting factors. If there was no response after a total of &gt;200 μg/kg, the indications for rFVIIa administration were re-checked. Results: After administration of rFVIIa, three patients had a complete response with cessation of bleeding. There was a decrease in the transfusion requirements in the single non-responder case who later died of massive myocardial ischemia. Most studies have shown that use of rFVIIa yields better results when given earlier rather than later. Nevertheless, our first patient encounter showed good result despite initiation of the therapy 3 weeks after the onset of bleeding. Finally, patient number 3 showed the first successful reported use of rFVIIa for bleeding associated with multiple myeloma. Conclusion: rFVIIa is effective in the life-threatening emergencies. However, because of the potential thrombotic complications, off-label use should probably be limited to life-threatening blood loss not otherwise controlled by other interventions. Cost/benefit ratio should also be evaluated on a case by case basis. Age (years)/sex details of the caused of bleeding Bleeding sites Period between the bleeding and the rFVIIa infusion dose/frequency Transfusion requirement pre-/post-rFVIIa Transfusion requirement pre-/post-rFVIIa Response after rFVIIa treatment /Response after rFIIa treatement/ 78/F Coumadin toxicity (INR &gt;10) Gross hematuria, epistaxis, hematochezia, hematemesis 3 weeks 90 μg/kg, 4 doses RBC 17/4,Plt 18/3,FFP 26/2,Cry 5/0 6.8/10.2 Complete in 24 hours/Recovered (INR 1.9) 51/F colon adenocarcinoma (Post-surgical) Surgical incision, Intra-abdominal 48 hours 0 μg/kg, 3 doses RBC 16/3, FFP 5/1 4/10 Complete in 48 hours/Recovered 59/M Multiple myeloma, (PT 44.9, INR 4.5, PTT 37) Hematemesis, hematochezia, melena 72 hours 90 μg/kg, 1 dose RBC 13/2, FFP 4/0 6.5/9.8 Complete in 3 hours/Recovered 49/F Hepatitis C cirrhosis (liver failure). Hematemesis, melena 48 hours 90 μg/kg, 8 doses RBC 12/7, FFP 7/3 6/- Partial in 24 hours/Died

High-Dose Cyclophosphamide (Cy), Rituximab, and a Cancer Vaccine for Relapsed Classical Hodgkin's Lymphoma (cHL)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3954-3954 ◽  
Author(s):  
Yvette L. Kasamon ◽  
Richard J. Jones ◽  
Hyam I. Levitsky ◽  
Ivan M. Borrello ◽  
M. Victor Lemas ◽  
...  
Keyword(s):  
Median Time ◽  
Cancer Vaccine ◽  
Research Funding ◽  
Cell Phenotype ◽  
High Dose ◽  
Off Label Use ◽  
Local Skin ◽  
Platelet Recovery ◽  
Off Label ◽  
Label Use

Abstract Abstract 3954 Background: Curative but less toxic regimens are needed for relapsed cHL, as autologous stem cell transplantation (auto SCT) carries ∼ 5% mortality risk and nearly 100% risk of infertility. Work at our institution showed that 1) high-dose Cy, equivalent to transplantation doses, can be given safely without SCT and the potential of reinfusing tumor cells, does not preclude any form of salvage SCT, and can spare fertility; and 2) unlike Hodgkin and Reed Sternberg (HRS) cells, cHL cancer stem cells may have a CD20+, memory B cell phenotype and circulate in surprisingly high frequencies (Jones RJ et al, Blood 2009;113:5920), potentially explaining rituximab's activity in this disease. Derived from the K562 cell line, the HL vaccine is a novel, allogeneic (allo), GM-CSF producing vaccine that expresses antigens commonly present in cHL including survivin. In addition, the vaccine expresses the EBV antigens LMP2 and EBNA1, commonly present in EBV+ cHL. Patients and Methods: A phase I/II study of high-dose therapy and immunotherapy for relapsed cHL was developed with curative intent. Eligibility included chemosensitive relapse (chemosensitivity testing was not required for low-volume relapse), no prior SCT, no primary refractory disease, and adequate end-organ function. Chemotherapy consisted of rituximab 375 mg/m2 IV on d 1 and 4, high-dose Cy (50 mg/kg/d IV on d 8–11) with mesna, filgrastim, and rituximab 375 mg/m2 IV weekly for 4 weeks upon platelet recovery. HL vaccine (1 × 10exp8 cells/dose) was administered 1 d after Cy completion and 4, 8, 12, 16, and 24 weeks later. Consolidative radiation was permitted. All treatment was intended to be outpatient. Results: Clinical outcomes of the first 25 pts accrued are described. Median age was 40 (range 18–67) y; 10 were female. Stage was IIB-IV in 14 pts (56%) upon diagnosis, and 9 pts (36%) relapsed with extranodal disease. HRS cells were CD20+ in 4/25 cases (16%), EBV+ in 6/24 evaluable cases (25%). Median time between first-line therapy completion and relapse was 12 (range 2–94) mo; 22 pts had CR or PR and 2 had stable disease to salvage therapy consisting chiefly of ICE or ESHAP (median 2 cycles, range 1–4), and 1 had untested relapse. With median 31 (range 7–53) mo follow-up for all pts, actuarial 1 y and 2 y overall survival is 100%, while actuarial event-free survival is 79% at 1 y and 66% at 2 y following high-dose Cy (Figure). The regimen was well-tolerated, and there was no treatment-related mortality. Eleven admissions occurred, 10 for infections (8 neutropenic, 2 non-neutropenic) which all resolved without sequelae, with 2 other neutropenic fevers managed without admission. One pt developed idiopathic protracted pancytopenia (gradually improving), cardiomyopathy, and chronic kidney disease. Vaccine toxicities were largely limited to mild local skin reactions. Median time to neutrophil recovery after the last dose of Cy was 17 (range 10–26) d; median time to sustained platelets >= 20,000/μL, without transfusion in the preceeding week, was 21 (range 0–46) d, with 5 pts not requiring platelet transfusion. Grade 3 or 4, late-onset neutropenia, presumably rituximab-related, was documented in 11 pts (44%; grade 4 in 5 pts) at a median of 3 (range 1–18) mo following study initiation. In the 7 relapsed pts, median time to relapse was 7 (range 5–16) mo after high-dose Cy; 1 died of disease after auto and allo SCT, 1 died in the course of allo SCT, 1 is alive with disease after allo SCT, 3 are event-free 7 mo - 3 y after allo SCT, and 1 has allo SCT planned. Early stopping rules for safety and efficacy have not been met. One pt had a successful pregnancy 33 mo after high-dose Cy. Conclusion: A novel outpatient regimen incorporating high-dose Cy and rituximab produces encouraging outcomes on preliminary analysis in relapsed cHL pts. Early efficacy appears comparable to that of auto SCT, with potentially less toxicity. Analyses of immunologic endpoints and HL biomarkers are in progress. Disclosures: Kasamon: Genentech: Research Funding. Off Label Use: Rituximab, cyclophosphamide: off-label use. Cancer vaccine: investigational. Levitsky:HL vaccine: Patents & Royalties. Borrello:HL vaccine: Patents & Royalties. Swinnen:Genentech: Consultancy, Research Funding.

Gemcitabine, Busulfan and Melphalan (GemBuMel) Is a New High-Dose Chemotherapy (HDC) Regimen with High Activity In Refractory Hodgkin's Lymphoma (HL) Patients Receiving An Autologous Stem-Cell Transplant (ASCT): A Contemporaneous Comparison with BEAM and Busulfan/Melphalan (BuMel)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 690-690 ◽  
Author(s):  
Yago Nieto ◽  
Paolo Anderlini ◽  
Uday Popat ◽  
Ping Liu ◽  
Borje S Andersson ◽  
...  
Keyword(s):  
Research Funding ◽  
Hodgkin’S Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Fixed Dose ◽  
High Dose ◽  
Cell Transplant ◽  
Off Label Use ◽  
Prognostic Features ◽  
Off Label ◽  
Label Use

Abstract Abstract 690 Background: BEAM is considered standard HDC for primary refractory or relapsed HL. However, pts with refractory HL have <30% chance of long-term event-free survival (EFS), underscoring the need for more active HDC regimens. Methods: We developed a new HDC regimen of gemcitabine (Gem), busulfan (Bu) and melphalan (Mel) (GemBuMel) exploiting their synergy. Bu was given as 4 daily doses on days −8 to −5 targeting an AUC of 4,000/d. Mel was given at 60 mg/m2/d on d-3 and d-2. Gem was infused over 3 hours at a fixed dose rate of 10 mg/m2/min (total dose 1875 mg/m2) on days −8 and −3 immediately preceding Bu and Mel, respectively. We compared the subset of refractory HL pts enrolled in this trial with all other refractory HL pts treated at MDACC with HDC during the same time period, who were eligible for the GemBuMel trial but either received BEAM off protocol or were enrolled in a separate trial of BuMel. All of these pts met ≥1 of the following criteria of refractory disease: primary induction failure (PIF) (defined as less than PR to 1st line chemotherapy), CR1 <6 mo, >1 relapse or progressive disease (PD) at HDC. Pts with relapsed but not refractory HL were not included in this analysis. Results: We analyzed 115 pts treated in one of the following three cohorts: 1) GemBuMel (N=51) since 01/07, median follow-up: 10 (2-43) mo; 2) BEAM (N=26) since 01/07, median f/u: 13 (3-56) mo; 3) BuMel (N=38) since 04/05, median f/u: 36 (17-56) mo. The GemBuMel cohort had significantly higher % PIF, median # prior relapses, % PET + tumors at HDC and % PD at HDC, with all other demographic and clinical features comparable (Table 1). There were no treatment-related deaths in any cohort. GemBuMel pts had improved EFS (Fig. 1) and OS (Fig. 2). GemBuMel was superior in patients with either PET- or PET+ tumors at HDC (Table 2). Cox proportional hazards regression models identified the use of a regimen other than GemBuMel (HR 2.38, P=0.02 for EFS; HR 8.25, P=0.009 for OS), >1 prior relapse (HR 2.91, P=0.006 for EFS) and B symptoms (HR 6.57, P=0.009 for OS) as independent adverse outcome predictors. Conclusions: Despite its worse prognostic features, the cohort of refractory HL pts treated with GemBuMel showed superior outcome to contemporaneous patients receiving BEAM or BuMel. A randomized trial of GemBuMel v BEAM is warranted. Disclosures: Off Label Use: Off-label use of gemcitabine for Hodgkin's lymphoma. Popat:Otsuka: Research Funding. Andersson:Otsuka: Consultancy. Champlin:Otsuka: Research Funding.

scholarly journals Treatment of Moderate to Severe Psoriasis With High-Dose (450-mg) Secukinumab: Case Reports of Off-Label Use

2017 ◽  
Vol 22 (1) ◽  
pp. 86-88 ◽  
Author(s):  
Jennifer Beecker ◽  
Jiyeh Joo
Keyword(s):  
Partial Response ◽  
Dose Escalation ◽  
High Body Mass Index ◽  
Severe Psoriasis ◽  
Response To Treatment ◽  
High Dose ◽  
Off Label Use ◽  
Off Label ◽  
First Case ◽  
Label Use

Treatment of moderate to severe psoriasis often requires systemic therapy, including biologics. Partial response to biologics and relapses are commonly managed with dose escalation. Secukinumab is a relatively new biologic that is currently used to treat moderate to severe psoriasis. There has been no literature published on dose escalation of secukinumab. This article describes the off-label use of a higher dose of secukinumab (450 mg every 4 weeks) instead of the standard dosing (300 mg every 4 weeks) in 2 patients with moderate to severe psoriasis. The first case involves a male patient with a high body mass index (BMI) (≥30 kg/m2) and severe psoriasis who was started on secukinumab at 450 mg following a partial response to treatment with the standard 300-mg dose. His psoriasis significantly improved with the higher dose of secukinumab. The second case discusses a female patient with treatment-resistant psoriasis and a BMI of 31.6 kg/m2 who initially achieved a complete remission with standard dosing of secukinumab. Later, her psoriasis relapsed and she was dose-escalated to secukinumab 450 mg in an attempt to recapture response, but this dose escalation was unsuccessful. In both cases, there were no adverse events observed with a higher dose of secukinumab. These cases demonstrate that dose escalation of secukinumab (450 mg rather than on-label 300 mg every 4 weeks) may be considered in selected patients with incomplete clearance, particularly for those with a high BMI. However, secukinumab dose escalation may not be as beneficial in patients with loss of efficacy.

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