Wednesday, July 10, 2024

Biologics For Psoriasis In India

Safety Profile Of Apremilast

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Laboratory Monitoring While Using Apremilast

In clinical trials on the efficacy and safety of apremilast, laboratory parameters did not show any significant derangements. Also, there was no evidence of cumulative or organ-specific toxicity.50 According to the prescribing information for apremilast, no laboratory monitoring is required.41 However, in a consensus study on the use of apremilast in psoriasis, published in 2020,8 and a real-world study by Mayba and Gooderham,7 it was recommended that laboratory monitoring should be carried out only in selected cases.

Based on the evidence, clinical experience, and survey results, the experts recommended that:

  • Laboratory monitoring in the form of complete blood count should be conducted at least once or twice a year in patients receiving apremilast. In patients on combination therapy, laboratory monitoring guidelines of the other agent should be adhered to.
  • Additional laboratory monitoring should be conducted according to the patients underlying disease.
  • From the above findings and less rigorous pre-screening, apremilast therapy is more convenient than other conventional therapies.

Common Side Effects of Apremilast

Based on the above findings and clinical experience with the use of apremilast, the experts opined that most of these AEs are mild in severity and resolve with time and appropriate pharmacotherapy, as also noted in the published literature.78

Dose Titration of Apremilast

Traditional Treatments Arent Working

Traditional treatment options for psoriasis include topical creams, corticosteroids, cyclosporine, retinoids, methotrexate, and phototherapy. People with mild to moderate psoriasis can usually manage their disease well with topical treatments. But these treatments often dont work well enough for those with moderate to severe cases. Some treatments may also lose effectiveness over time.

If you have moderate to severe psoriasis and your current treatment regimen isnt working, its time to start considering a biologic. The American Academy of Dermatology suggests taking a biologic agent if you have moderate to severe psoriasis that hasnt improved using more traditional systemic agents or you cant tolerate those treatments because of side effects.

Effectiveness Of Apremilast In Combination With Systemic Drugs

According to the survey results, a combination of apremilast is documented with other anti-psoriatic agents, such as methotrexate, acitretin, cyclosporine, and other biologic therapy. This was corroborated by the published literature.16

Methotrexate was found to be most commonly prescribed drug, along with apremilast, followed by cyclosporine. This combination has been previously proven as a good and effective combination for the treatment of psoriasis. It has also been proven that methotrexate and apremilast can be coadministered without any effect on the pharmacokinetic exposure of either agent.17 The panel suggested that the combination of cyclosporine and apremilast could be a viable option in severe psoriasis by virtue of rapid relief with cyclosporine, followed by apremilast continued for a longer duration to maintain remission.

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Main Cytokines And Cell Types In Plaque Psoriasis

Disturbances in the innate and adaptive cutaneous immune responses are responsible for the development and sustainment of psoriatic inflammation . An activation of the innate immune system driven by endogenous danger signals and cytokines characteristically coexists with an autoinflammatory perpetuation in some patients, and T cell-driven autoimmune reactions in others. Thus, psoriasis shows traits of an autoimmune disease on an inflammatory background , with both mechanisms overlapping and even potentiating one another.

The main clinical findings in psoriasis are evident at the outermost layer of the skin, which is made up of keratinocytes. However, the development of the psoriatic plaque is not restricted to inflammation in the epidermal layer, but rather is shaped by the interaction of keratinocytes with many different cell types spanning the dermal layer of the skin. The pathogenesis of psoriasis can be conceptualized into an initiation phase possibly triggered by trauma , infection, or drugs and a maintenance phase characterized by a chronic clinical progression .

The pathogenesis of psoriasis.

The activation of the adaptive immune response via the distinct T cell subsets drives the maintenance phase of psoriatic inflammation . Th17 cytokines, namely IL-17, IL-21, and IL-22 activate keratinocyte proliferation in the epidermis.

Minimum Time Required For Showing Efficacy And Extent Of Remission In Plaque Psoriasis

(PDF) Biologicals in the treatment of psoriasis: The ...

A study conducted on six patients with palmoplantar psoriasis showed that all the patients had improvement in disease within the first 4 weeks of treatment.25 The ACTIVE trial demonstrated the early onset of action of efficacy of apremilast in biologic-naïve patients with psoriatic arthritis.27 The UK National Institute for Health and Care Excellence recommends stopping apremilast if an adequate response is not attained by 16 weeks. An adequate response is defined as attainment of PASI 75 or PASI 50 with a five-point reduction in the Dermatology Life Quotient Index .28

When asked about the minimum time period to show efficacy, a consensus was generated that apremilast showed efficacy within 46 weeks of initiation of treatment, as evidenced by PASI 50 or an equivalent fall in BSA or physician global assessment in patients.

Overall, 86.7% of the clinicians in our survey reported that up to 50% of their psoriasis patients have complete clearance of disease within 16 weeks of apremilast therapy. However, the results of this survey also showed that the response of apremilast in the remaining patients was low to moderate. This has been proved by Verbenko et al, who pointed out the role of genetic polymorphisms as important factors for individual variations in drug response in psoriasis.29 Moreover, this rate of remission among Indian psoriasis patients as reported by the dermatologists is commensurate with worldwide trials.30

Table 2 Place of Apremilast in Psoriasis Management

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Biologics Treatment For Psoriasis In India

Theres nothing fun about having a flaky, itchy scalp. Some experience small flurries of flakes when their scalp is dry,

Biologics are protein-based drugs derived from living cells cultured in a laboratory. Biologic drugs are a relatively new class of treatment for.

The biologics currently in use for psoriasis in India are etanercept, infliximab and.

The decision to proceed with treatment must be made in.

The biologics currently in use for psoriasis in India are etanercept, infliximab and.

Patients with psoriasis may be considered eligible to receive treatment with.

Hoth Initiates Preclinical Gene Therapy Program with NC State for the Treatment of Asthma and Allergic Inflammation /PRNewswire/ Hoth Therapeutics, Inc. , a biopharmaceutical company focused on unique targeted therapeutics.

Various biologics currently used in the treatment of psoriasis have been listed in . The biologics and biosimilars which.

Dose reduction of biologics adalimumab, etanercept, and ustekinumab was not shown to be as effective as providing the usual doses for treatment of psoriasis, according to study findings published.

Parasramani SG, Pillai J. Biologics in psoriasis: Indian experience. Indian J Drugs Dermatol 2019 5:1-5.

Mumbai: Indian patients of psoriasis, a chronic, autoimmune skin.

The treatment cost for biologics ranges from Rs300,000 to Rs600,000 per.

/PRNewswire/ Allied Market Research recently published a report, titled, “Psoriatic Arthritis Treatment Market by Drug.

Patients With Hepatitis B Or C

Similarly to patients with HIV, management of psoriatic patients with chronic infections such as hepatitis B and hepatitis C is challenging because of the increased chances of reactivation of the disease and liver toxicities associated with anti-psoriatic therapies.65

Only three patients with chronic viral hepatitis treated with apremilast have been described in the published literature.62,66,67 From these reports, it was concluded that apremilast was associated with neither reactivation of disease, nor elevation of liver enzymes, nor viral load in active disease. Excessive alcoholism is associated with fatty liver and is also a trigger factor for psoriasis.68 It has been found that apremilast produces stable reductions in voluntary ethanol consumption and is rapidly distributed to plasma and tissues , suggesting its usefulness for medication development and repurposing efforts to treat alcohol misuse.69

Apremilast is not contraindicated in patients with active infections and does not have hepatotoxic effects hence, it can be used in severe hepatic impairment without dose reduction.65

Apremilast exerts an anti-fibrotic action in animal models by inhibiting pro-fibrotic factors such as transforming growth factor- and interleukin-13,70 which could potentially have a positive impact on liver fibrosis. In light of these data, apremilast is not only innocuous but also potentially beneficial in patients with commonly prevalent non-alcoholic fatty liver disease.

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Tumor Necrosis Factor Alpha Blockers In India

TNF plays a central role in the pathogenesis of psoriasis, psoriatic arthritis, and a number of other disease states. TNF is released from cells as a soluble cytokine following cleavage from its cell surface-bound precursor . Both sTNF and tmTNF are biologically active, and bind to either of the two distinct receptors: TNF receptor 1 and TNF receptor 2. This leads to NF-kB activation and or cell apoptosis. In addition, tmTNF can itself act as a ligand to induce cell activation, cytokine suppression, or apoptosis of the tmTNF bearing cell. Soluble forms of the TNF receptors also exist, and by binding and neutralizing sTNF, may act as natural TNF antagonists. There are currently two approved groups of biologic agents that target TNF: anti-TNF monoclonal antibodies , and sTNF receptors . Adalimumab is not currently available in India. Infliximab is a chimeric humanmurine monoclonal antibody Etanercept is a genetically engineered fusion protein composed of a dimer of extracellular portions of human TNFR2 fused to the Fc domain of human IgG1.

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ALZUMAb Infusion Process

Biocon, India’s largest publicly-held biotechnology firm, on Saturday launched its second novel ‘lab-to-market’ molecule, Alzumab, to treat chronic plaque psoriasis at a cost 50 per cent lower than the existing one.

The Biocon drug, at around Rs 7,500 a vial, will cost half as much as the currently available drugs – from Pfizer and J& J – to treat psoriasis, a skin disease that causes rough red areas where the skin comes off in small pieces. A patient is usually prescribed to consume more than 40 vials in a 24-week course.

Biocon is bringing Alzumab in the form of a vial after working on it for nearly a decade. The work had initially started in a joint effort with the Center of Molecular Immunology, Havana, but Biocon took control of the programme soon after and also bought out its partner a few years ago.

The company currently has the approval to market this drug in India but it plans to start the process to take it to restricted markets like the US through strategic partnerships. The company on Saturday said its total cost of bringing the drug to the Indian market was just a fraction of the $1 billion normally required to bring a novel drug to the market. However, the cost might increase exponentially as Biocon takes the drug to global trials. So, the company is looking for a partner to make parallel investments and take the drug to the global stage. The company’s management said it considered the drug a very valuable licensable asset.


Cost factor:

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Can Biosimilars Be Used With Other Treatments

It is important to tell your health care provider about all treatments, medicines, vitamins or supplements that you are taking.

Like all biologics, biosimilars can be used with other treatment options including topicals and phototherapy. The biologics Enbrel, Humira and Remicade are shown to be safe and effective when taken with methotrexate. This means that their biosimilars, including Erelzi, Amjevita, and Inflectra, may be safe and effective when taken with methotrexate.

  • With Inflectra being the biosimilar to Remicade, its use in combination with phototherapy may increase the risk for skin cancer.
  • No drugs that interact with biologics should be combined with their respective biosimilars.

Pretreatment Assessments And Monitoring

Recommendations for TB screening prebiologic from the british thoracic society

  • A pretreatment chest X-ray and Mantoux skin test currently remain the preferred screening tests in patients not on immunosuppression. Tuberculin testing is not valid in patients already established on immunosuppressive therapy . IGRA tests may have a role in this group and can be used, if practicable, although the positive and negative predictive values are unknown

  • The T-SPOT.TB test may be more sensitive in patients on immunosuppressive drugs. Patients with signs to suggest TB or a history of previous treatment for TB should be referred to a TB physician. Patients with test to support latent TB should be stratified for risk and considered for prophylactic antituberculous therapy further advice should be sought from a TB physician when necessary. When antituberculous therapy is indicated, patients should complete 2 months of treatment before commencing biologic therapy with either isoniazid , or rifampicin plus isoniazid , or rifampicin alone

  • During treatment and for 6 months following discontinuation, a high index of suspicion for TB should be maintained, especially in those at high risk. For patients on biologic therapies longer than 1 year who have negative screening tests for TB on initiation of therapy, annual assessment for TB may be considered in high-risk patients using whichever IGRA is locally available.

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Your Current Therapy Is Causing Side Effects

Psoriasis treatments like cyclosporine, corticosteroids, and methotrexate are known to cause side effects like mouth sores, nausea, upset stomach, and even skin cancer.

Biologics work in a more selective way than other psoriasis treatments. They target specific proteins in the immune system that have been proven to be associated with psoriasis. For this reason, they have fewer side effects than less targeted treatments.

Biologics can still cause side effects, but they tend to be less severe. The most common side effects are minor irritation, redness, pain, or a reaction at the site of injection. Theres also a slightly higher risk of serious infections.

Another possibility is to take a combination of your current therapy along with a biologic. By combining treatments, you can improve the efficacy of your treatment and lower the dose. This helps to decrease side effects. certolizumab pegol , etanercept , adalimumab , and infliximab have been shown to be safe and effective when taken with methotrexate.

Indications For Stopping Therapy

Biologics use in Indian psoriasis patients Rajagopalan M ...
  • Patients fail to achieve an adequate response following treatment initiation or when treatment response is not maintained

  • A serious adverse event. Serious adverse events which may justify the withdrawal of treatment include malignancy , severe drug-related toxicity, and severe intercurrent infection

  • Pregnancy

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Significantly Less Progression Than With Phototherapy Alone

byNancy Walsh, Contributing Writer, MedPage Today June 23, 2021

Patients with moderate-to-severe plaque psoriasis who were treated with biologics were less likely to develop psoriatic arthritis than if they received phototherapy, Italian researchers reported.

Among psoriasis patients who were given treatment with biologic agents, the annual incidence rate for PsA was 1.20 cases per 100 patients compared with an incidence rate of 2.17 per 100 for those treated with phototherapy, according to Paolo Gisondi, MD, of the University Hospital of Verona, and colleagues.

In a multivariate analysis that adjusted for numerous factors including age and sex, as well as duration, localization, and severity of psoriasis, the hazard ratio for the development of PsA among patients receiving biologic treatment was 0.27 , they reported in Annals of the Rheumatic Diseases.

Up to one-quarter of individuals with psoriasis eventually develop PsA, often 5 to 10 years after the skin lesions first appear. “The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” Gisondi’s group wrote.

Among the biologics group, 17% received infliximab , 7% were given etanercept , 29% received adalimumab , 21% were taking the interleukin -12/23 inhibitor ustekinumab , and 26% were on the IL-17A inhibitor secukinumab .


Primary Source

How Biologics Are Going To Be The Driving Force For Indian Pharma

  • The author of this article is Dr R.B Smarta, Chairman and Managing Director, Interlink

As the healthcare scenario is experiencing the paradigm shift from cure to care, preventive health has received generous importance and hence the biologics. Growing demand for vaccines, monoclonal antibodies and biosimilars are creating excellent business space for Indian pharma.

Indian pharmaceutical sector has great potential to earn the identity of global hub for manufacturing biologics. The ability to invent globally competitive, affordable and novel vaccines and biosimilars is emerging as one of the greatest driving forces for Indian pharma. As the industry is shifting from chemical-based drugs to biosimilars and biologics, this scenario presents excellent opportunities for Indian pharma industry in the space of life sciences and biotechnology.

Till September 2019, India received over 98 biosimilars approvals in the domestic market, more than any other country. Moreover, the approvals which we are receiving for biosimilars in regulated market, further boosting the confidence and willingness of Indian pharma players to contribute in global market shares. Owing to the rising domestic demand, potential and investments in biologics in India, according to the reports, more than 40 biosimilars reached clinical development stage in India which is far more than that of United states and similar to European Economic Areas.

Vaccines establishing strong presence

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Specific Issues For Individual Agents


Injection site skin reactions occur in up to 37% of patients treated with etanercept, which are mild-to-moderate and generally do not require drug discontinuation.


Infusion-related reactions occur in 16% of patients treated with infliximab compared with 6% of patients treated with placebo. The majority of the infusion reactions are mild consisting of pruritus or urticaria. Some patients have moderate reactions consisting of chest pain, hypertension, and shortness of breath, and only rarely severe reactions with hypotension and anaphylaxis occur. Infusion reaction risk tends to correlate with the development of human antichimeric antibodies and can usually be managed by slowing the rate of infusion or stopping the treatment entirely. Concurrent treatment with methotrexate can reduce this reaction and antibody formation.


Infusion-related reactions are seen in 20% of patients. Rarely exfoliative dermatitis, erythrodermic psoriasis, adjustment disorder with anxiety, and bacterial arthritis can be noted.


Incidence of infective adverse events need continued vigilance particularly, with respect to potential for candida infection.

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