Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Muscle spasms, Psoriasis, Psoriatic arthropathy, Therapeutic product effect decreased
Clinical narrative: Otezla was not working /on Enbrel, medication stopped working/Otelza doesn't seem to work /having big flare-up/ Otezla not working; leg cramps; spots coming back and her elbows are bad /she is having a big flare-up right now/had flare recently/ flare up on her back; she is having a big flare-up right now/Psoriatic spondylitis/Psoriatic arthropathy/ flares recently/flare up on her back; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021026430), license party for etanercept (ENBREL).  This solicited report (USASL2021026430) was reported to Amgen on 17/FEB/2021 by a consumer from a commercial program (PSP10464) and involves a 60-year-old female patient whose spots were coming back and her elbows were bad again [PT: psoriasis] and Otezla was not working like it used to/ her body got used to Enbrel so the medication stopped working [PT: therapeutic product effect decreased] while receiving Otezla, Enbrel. No historical medical condition was reported. The patient's current medical condition included psoriasis vulgaris, arthropathic psoriasis and psoriatic spondylitis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On an unknown date, the patient's body got used to Enbrel, so the medication stopped working, and the patient took a break. The patient restarted Enbrel again and it helped/ worked. The patient began Otezla on an unknown date. The patient was no longer on Enbrel since starting Otezla. It was also reported that the patient saw huge improvements after the first month of being on Otezla, but since on an unknown date, the patient had spots coming back and her elbows were bad again. On an unknown date, Otezla was not working for the patient like it used to. The patient also said that Otezla stopped working. No treatment information was received. The outcome of the event psoriasis was reported as not recovered/not resolved. The outcome of the event therapeutic product effect decreased was reported as unknown. Action taken with Otezla was reported as unknown for the events psoriasis and therapeutic product effect decreased. Action taken with Enbrel was temporarily withheld for the event therapeutic product effect decreased. The consumer reported that the event therapeutic product effect decreased was possibly related to Otezla and Enbrel. The causal relationship between the event psoriasis and Otezla and Enbrel was not provided by the consumer. Follow up has been requested.  The reporter's assessment of the causal relationship of the event Psoriasis flare-up with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    Amgen's assessment: Event Drug effect decreased was assessed as non-serious and related to etanercept. Event Psoriasis flare-up was assessed as non-serious and unrelated to etanercept.  Follow-up (23Feb2021): New information received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021026430), license party for etanercept (ENBREL).  In this follow up, it was stated that the patient did not know the lot number. The patient stated that she had an appointment with her prescriber on 23Feb2021 and would discuss about staying on Otezla and also going back on Enbrel if that would be a better solution for her situation.  Causality assessment for Drug effect decreased per company (Amgen) was Yes, while for Psoriasis flare-up per company (Amgen) was No.  Follow-up (19Mar2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021026430), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 19/MAR/2021: This case was upgraded to serious. In additional information it was reported that the patient was having a big flare-up right now/ psoriatic spondylitis/ psoriatic arthropathy [PT: psoriatic arthropathy, psoriasis], Otelza did not seem to work like it did in the beginning/ having a big flare-up [PT: therapeutic product effect decreased] while receiving Otezla. Since JAN/2021, about two months prior to the report, Otezla did not seem to work like it did in the beginning and she had been having a big flare-up. The patient planned to make an appointment with her doctor in coming week to discuss this information. The outcome of the event psoriatic arthropathy was reported as not recovered/not resolved. Action taken with Otezla was reported as unknown for the event psoriatic arthropathy. The causal relationship between the event psoriatic arthropathy and Otezla and Enbrel was not provided by the consumer.  The reporter's assessment of the causal relationship of the events Psoriatic arthropathy aggravated, Psoriasis flare-up with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen Comment: This individual case report does not change the safety profile of the product.  Amgen Causality Assessments: Psoriatic arthropathy aggravated, Psoriasis flare-up assessed as unrelated to etanercept while Drug effect decreased assessed as related to etanercept.  Follow-up (23Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021026430), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 23/APR/2021: This follow-up information was reported by the consumer. It was reported that a 60 years old patient's Otezla was not working as well as it used to [PT: therapeutic product effect decreased] while receiving Otezla and Enbrel. The patient's current medical condition included arthropathic psoriasis unspecified. On an unknown date, the patient reported that Otezla was not working as well as it used to. The patient did not speak with a clinician, so lot number could not be obtained. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Amgen comment: This individual case report does not change the safety profile of the product.  Amgen Causality assessment: Drug effect decreased is related to etanercept. Psoriasis flare-up and Psoriatic arthropathy aggravated are unrelated to etanercept.  Follow-up (24Sep2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021026430), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 24/SEP/2021: In this follow-up information it was reported that the patient had flares recently [PT: Psoriatic arthropathy, and PT: psoriasis], she feels Otezla was not working for her symptoms [PT: therapeutic product effect decreased] and leg cramps [PT: muscle spasms] while receiving Otezla and Enbrel. On an unknown date, the patient felt Otezla was not working for her symptoms. The patient stated that flares recently and also had leg cramps. The outcome of the events muscle spasms was reported as unknown. Action taken with Otezla was reported as unknown for the event muscle spasms. Action taken with Otezla was reported as unknown for the event muscle spasms. The causal relationship between the event muscle spasms and Otezla was not provided by the consumer. The causal relationship between the events muscle spasms and Enbrel was not provided by the consumer. The reporter could not read and could not find lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that apremilast, etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events (EXCEPT therapeutic product effect decreased) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Amgen Causality assessment: Drug effect decreased is related to etanercept. Psoriasis flare-up and Psoriatic arthropathy aggravated, and Leg cramps are unrelated to etanercept.  Follow-up (02Dec2021): This is a solicited follow-up report from a contactable consumer, from License Party (Amgen). Other Identifiers: US-AMGEN-USASL2021026430, US-AMGEN INC-21-0115586-SR-01, US-AMGEN INC-21-0081217-SR-01, US-AMGEN INC-21-0267244-SR-01, US-AMGEN INC-21-0048293-SR-01, US-AMGEN INC-21-0332209-SR-01(Amgen).  ADDITIONAL INFORMATION RECEIVED ON 02/DEC/2021: The patient had flare up on her back [PT: psoriatic arthropathy and PT: psoriasis] while receiving Otezla, Enbrel. The patient's concomitant medication included methotrexate. The patient's co-suspect medication included Covid-19 Vaccine. On an unknown date in 2021, the patient had flare up on her back, but believes it was due to the Covid-19 Vaccine. The patient's physician had switched back to Enbrel and the patient was also taking methotrexate. The outcome of the events psoriatic arthropathy and psoriasis was reported as unknown.  Amgen's comment: This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Amgen.  The reporter's assessment of the causal relationship of the events (EXCEPT therapeutic product effect decreased) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   Amgen Causality assessment: Drug effect decreased is related to etanercept. Psoriasis flare-up and Psoriatic arthropathy aggravated, and Leg cramps are unrelated to etanercept.; Sender's Comments: Based on the available information provided, the causal association between the event drug effect decreased and etanercept, cannot be excluded. The said event is considered unrelated to BNT162B2. On the other hand, the events Psoriatic arthropathy aggravated, Psoriasis flare-up, and leg cramps are likely intercurrent or due to the patients underlying unreported medical conditions that are unrelated to the suspect drugs (etanercept and BNT162B2). Case to be reassessed should a follow-up information becomes available.